Protocol Tracking Reports: Dashboard
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| Breast Cancer | ||
| S2511 Randomized Phase III trial of multimodality therapy versus standard of care systemic therapy in HER2 positive (HER2+) de novo (AJCC stage IV) oligometastatic breast cancer with response to initial chemotherapy |
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Capsule Summary Approval Date: 04/07/2025
Concept or Lol submit to NCI: 05/16/2025 Target Date: 03/14/2026 Drop Dead Date: 03/09/2027
Progress:
317
of 270 days
Current Status: 04/07/2026: Resubmission to CTEP addressing their Consensus Review was completed on 03/19. CTEP Approval-on-Hold status received on 04/03. Initial CIRB submission completed 04/07. 03/03/2026: CTEP Steering Committee review held on 02/19. CTEP Consensus Review comments were received on 02/25. The study team is currently addressing CTEP's comments as we work toward resubmission within the next two-weeks. 02/03/2026: The initial CTEP submission was completed on 01/28. Currently pending CTEP Consensus Review comments. 01/06/2026: PRC edits were received from SDMC on 12/13. The post-PRC protocol version was shared with the study team on 12/15 for review and final revision recommendations. Nationwide and IROC are also reviewing the post-PRC protocol with edits due this week. We are targeting submission to CTEP within the next 2–3 weeks. 12/02/2025: PRC set for 12/03; initial CTEP submission targeted for late December or early January. 11/04/2025: RaPID held on 10/30, ICD review set for 11/05, PRC scheduled for 12/03. 10/06/2025: RaPID call scheduled for 10/30; ICD Review scheduled for 11/05. 07/18/2025: BCSC approval received, RaPID call is pending scheduling. 07/01/2025: Pending receipt of the concept review comment(s)/decision. 06/17/2025: BCSC concept review scheduled. 05/16/2025: Concept submitted to BCSC. 05/13/2025: F&F Call occurred. 04/07/2025: Capsule Approved; Study Team Kick-off scheduled for 04/28. |
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| Cancer Care Delivery | ||
| S2424CD A Randomized Controlled Trial of an Intervention called Algorithm-Enabled Patients Activated in Cancer Care through Teams (A-PACT) to Improve Goals of Care Communication for People with Cancer |
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Capsule Summary Approval Date:
Target Date: 11/11/2025 Drop Dead Date: 05/31/2026
Progress:
425
of 255 days
Current Status: 4/6/26: Received draft of Justification for PI change. (Updated budget still to come). 3/30 and 4/1: Received study chair edits. Incorporating and will submit to DCP this week. (CRA liaisons to review revision prior to DCP submission to make sure the language is clear). 3/27/26: Had call with DCP to discuss revision. Came up with plan to clarify revision. There will be a change in PI leadership. (Dr. Manz leaving. Study chairs will submit PI change plan and updated budget.) 3/25/26: Pre-activation revision is disapproved. 3/13/26: DUA with Stanford is finalized. 3/6/26: Pre-activation Revision submitted. 3/3/26: Stanford IRB approved protocol. 2/24/25: Received DCP final approval. Also, after discussion with CCD leadership at DCP, they extended the absolute deadline to 5/31/26. SWOG new target activation date is 4/15/26. (Pending Stanford IRB approval of study and DUA sign off). 2/11/26: Received CIRB final approval. 2/4/25: Ashley Buscetta, DCP/CCD lead, scheduled a call to go over our response to CIRB letter. Call is likely cancelled due to the furlough, however, I sent her and her team the draft of our response. We will move forward with submission to CIRB on 2/4. 1/23/26: Received "Approval Pending Modifications" letter from CIRB. Study team disagrees with making the exploratory endpoint based on the Heard and Understood measure a co-primary endpoint of the study. Other item brought up by CIRB was to include the rationale for choosing hospitalization as the primary endpoint to the background of the study. 12/23/25: Request for extension approved by DCP. New absolute is 3/11/26. Working on pre-activation draft. Will provide to Cara for site initiation slide set. 12/15/25: Submitted Response to "Tabled" letter and updated protocol documents to CIRB. Awaiting response. Request for extension of 60 days submitted. 12/1/25: Received consensus review - status of "TABLED". CIRB is questioning choice of primary outcome. Study team will be pushing back and providing clarification and further rationale. We will not be changing the primary endpoint at this stage. Working on responses which are due back 12/15. 11/25/25: CIRB Review. 11/24/25: Received initial questions from CIRB. Responses returned. 11/4/25: Received Approval on HOLD. 10/15 and 10/17: Response to Pending letter submitted to DCP and accepted. Waiting on "Approval on Hold". Deadline to submit to NCI CIRB is 11/11 (for review on 11/25). Solicitation of sites is ongoing. 9/16/25: Received Pending Letter. Deadline for response and protocol changes is 10/16/25. 8/26/25: Re: status of DUA with Stanford.Stanford requires that the study be approved by CIRB in order to execute. I will keep an eye on timeline in case we need to submit a request for extension. Absolute deadline is 1/10/26. 8/26/25: Response to DCP Consensus Review submitted. 8/14/25: According to Rave Status call, target activation for this study was pushed to 12/1. 7/29/25: Call with Kate Castro's group to discuss consensus review. It was a good call with items clarified about R01 differences and inclusion of longitudinal exploratory aims with minimal site burden and cost. Request from DCP to list Member and Special member institutions (Stanford and Emory) as non-accruing sites on a limited institution table on the protocol. Deadline to submit response is 8/26. 7/21: DUA executed with Emory. 6/26/25: Received the DCP Consensus review. Deadline for response is August 26, 2025. Internal deadline for responses is 7/11. 5/20/25: Submitted to DCP. Awaiting DCP consensus review. 4/29/25: Received study chair edits. 4/28/25: Communicated with Shane that there will be DUA for this study (with Stanford and Emory). 4/15/25: Received PRC edits from Sarah. 3/26/25: Protocol reviewed by PRC. Comments due to me by 4/9/25. Goal is to submit protocol on 5/15/25. 3/21/25: Working toward 3/26/25 PRC. 2/19/25: NOA received. Grant start date is 3/1/25. New target activation date is 11/21/25. Absolute deadline is 1/10/26. 2/14/25: Post-rapid protocol and MCF circulated to study team for comments. Due 2/21/25. 1/31/25: Rapid call completed. Working on updates. NOA has not been received. 1/7/25: Trying to set the Rapid date for 1/31/25. Awaiting confirmation from Statisticians. 12/16/24: Kate Castro hosted R01 call. New grant start date will be 1/1/25. OEWG deadline has been updated. Target deadline is 9/23/25. Absolute deadline is 11/12/25. 12/13/24: Goal is to get the pre-RAPID study draft to the team prior to the holidays. 12/3/24: Received first draft of protocol and MCF. Asked Dr. Parikh to forward NOA document. 11/5/24: Drafting timeline. Drafting Study Assumptions Worksheet. Setting up poll for biweekly study team calls. Need to do: schedule risk assessment with Dana and set up F&F call, Start working on "Study Descriptions to facilitate PRO Permissions" spreadsheet. 10/29/24: Study chairs received their Just in Time request. Grant start date will likely be 12/1/24. (if grant start date is 12/1/24, looking at target activation of August 2025, and absolute deadline of October 2025. 9/9/24: Sent protocol template to study chairs. 8/1/24: Dr. Parikh hosted R01 check in. Went over next steps. Awaiting estimate for NOA (grant start date). Dr. Castro to host R01 expectations call in October. 6/28/24: Dr. Parikh received notification that the R01 scored in the 4th percentile therefore likely will be funded. We will await the funding decision but need to get started on next steps planning. 2/5/24: R01 submitted. 1/22/24: Approved by Triage. 11/14/23: PRO measures reviewed by PROCore Team. Recommendations distributed to study chairs on 11/15/23. |
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| comboMATCH | ||
| EAY191-S9 Phase 2 study of Inavolisib in combination with Ribociclib in PIK3CA aberrated Head & Neck + GYN cancers |
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Capsule Summary Approval Date: 08/11/2025
Concept or Lol submit to NCI: 11/21/2025 Target Date: 05/23/2026 Drop Dead Date: 05/18/2027
Progress:
157
of 180 days
Current Status: 4/7/26: Study team is working on first draft of protocol. Scheduling for study team KOC and RaPID in progress. Still pending drug commitment due to incorrect email addresses. 3/20/26: Concept approved by CTEP, pending drug commitment from GNE and Novartis. 2/20/26: Additional comments from CTEP received. Study team is working on edits. The concept will be resubmitted by 3/6/26. 1/26/26: Revised concept submitted to CTEP. 1/9/26: Conference call with CTEP. 12/16/25: Consensus review comments received from CTEP. CTEP identified "major issues that require further consideration" prior to concept approval. 11/24/25: Concept presented to SWOG exec committee (as an FYI) 11/21/25: Concept submitted to CTEP 10/15/25: Concept reviewed by stats PRC 8/11/25: Concept approved by ComboMATCH steering committee |
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| Early Therapeutics & Rare Cancers | ||
| S2505 Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB, Extremity, Resectable Soft Tissue Sarcoma |
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Capsule Summary Approval Date: 11/06/2024
Concept or Lol submit to NCI: 02/12/2025 Target Date: 01/30/2026 Drop Dead Date: 12/02/2026
Progress:
360
of 270 days
Current Status: 4/03/26: CIRB Initial Application submitted 4/02/26: CTEP approval on hold 3/24/26: Submitted revised protocol, consent, PI response to CTEP. 2/27/26: Received comments on protocol from NCI, team is working on response plan to send response to NCI by next week. 2/3/2026: Finalizing PI response to NCI consensus review comments, plan to resubmit to CTEP this week. 1/5/2026: STrS application was disapproved by triage/ Imaging proposal was approved by triage and will be be added to current version of the protocol. 12/15/2025: Received CTEP consensus comments. 12/2/2025: CTEP had a scheduled review 11/26/25, pending comments. 11/4/25: Pending CTEP consensus review comments on protocol and consent. Imaging proposal is pending triage review. 9/18/25: Protocol and consent have been submitted to CTEP for initial review. 9/2/25: Finalizing protocol and consent for initial CTEP review, plan is to submit next week. 8/5/25: 2nd call RaPID calls was completed 7/31/25. PRC is scheduled 8/13/25 7/1/25: RaPID scheduled 7/8/25, PRC is scheduled for 8/13/25. 6/2/25: 1st draft of protocol has been circulated, scheduling RAPID *end of June-Early July. 5/5/25: Concept was approved by CTEP. 4/29/25: Concept was resubmitted. 4/25/25: Call with CTEP occurred, reviewers were pleased with PI responses to their comments and asked for concept to resubmitted. 3/18/25: Concept Review comments "The Committee was supportive of the proposed trial; however, before this concept can be approved, the following major comments will need to be addressed and submitted with a Revised Concept. " Call with CTEP to discuss comments is scheduled for 4/7/25. 3/4/25: Concept was submitted to CTEP 2/12/25 2/4/25: Pending executive officer approval to submit concept to CTEP 11/6/24: Triage approved capsule S2310: 7/25/24: Call with CTEP to discuss disapproval letter, SC provided responses to disapproval 6/10/24: Received concept disapproval 3/29/24: concept was submitted to CTEP for review. 1/29/24: Triage approved |
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| Gastrointestinal Cancer | ||
| S2605 Preoperative Chemotherapy versus Surgery First (CRS-HIPEC) for High Grade Appendiceal Carcinoma. |
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Capsule Summary Approval Date: 09/24/2025
Concept or Lol submit to NCI: 12/16/2025 Target Date: 10/23/2026 Drop Dead Date: 07/20/2027
Progress:
94
of 270 days
Current Status: *10/17/2025: Triage Approval Letter received and SWOG study ID assigned (S2605). 10/22/2025: Met with Dr. Unger and Dr. Jones to review PRO-related feedback from the Triage Committee and outline revisions to strengthen the concept and address feasibility considerations. 10/24/2025: Held the first Study Team Kickoff Call to discuss proposed concept updates, confirm development priorities, and establish a preliminary timeline for Steering Committee submission. Week of 11/3/2025: Refining concept documents based on feedback and preparing the SAWS worksheet. Week of 11/17/2025 (Target): Planning to hold the F&F call; currently confirming availability with stakeholders 11/21/2025: F&F Call - notes and updated concept circulated on 11/24/25. 12/15/2025: submission to GISC 01/26/2026: NCI GI Steering Committee Review 2/10/2026: Received Outcome Letter - Pending Status [A major concern was the weakness of the supporting data in that the datasets were relatively small and entirely observational, raising the probability of substantial bias as the reason for the noted outcome differences between the two sequences.] 2/24/2026: Meeting with GI Steering Committee to review comments 3/2/2026: Concept resubmitted to PIO 3/16/2026: Final review of Concept. 04/06/2026: Received Approval letter from NCI - Will circulate an email to all stakeholders on 4/7, begin scheduling study team calls, and start developing the first draft of the protocol. Our target submission to PIO is July 2026. |
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| S2610 Randomized Phase III Study of Anti-EGFR Therapy plus Irinotecan vs Trifluridine-Tipiracil plus Bevacizumab for Previously Treated Metastatic RAS/RAF Wild Type, Right-sided Colon Cancer |
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Capsule Summary Approval Date: 02/19/2026
Concept or Lol submit to NCI: 03/23/2026 Target Date: 01/15/2027 Drop Dead Date: 04/20/2026
Progress:
10
of 270 days
Current Status: 5/08/26: F&F Scheduled 4/20/26: Concept will be reviewed by GISC 3/23/26: Concept submitted to GISC 2/19/26: Triage Approval Letter received and SWOG study ID assigned (S2610) |
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| Genitourinary Cancer | ||
| S2611 A Randomized Comparison of Intravesical TherapieS (ARCIS): A randomized phase III study of intravesical gemcitabine and docetaxel (GEM-DOCE) versus intravesical cretostimogene grenadenorepvec and gemcitabine (CRETO-GEM) for the treatment of bacille Calmette-Guerin (BCG)-unresponsive and BCG-exposed non-muscle invasive bladder cancer (NMIBC) |
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Capsule Summary Approval Date: 11/18/2025
Concept or Lol submit to NCI: 04/22/2026 Target Date: 02/14/2027 Drop Dead Date: 11/11/2027
Progress:
-20
of 270 days
Current Status: 11/18/25: Triage Approved 11/24/25: Risk assessment completed - communicate proactively w/new company (CG Oncology) 12/2/25: F&F call scheduled for 12/16 (calendar invite will be sent 12/2). GUSC review for January - deadline to submit is 12/24 1/6/26: Concept and LOS submitted on 12/17 for GUSC review on 1/21. Scheduling slides review/anticipated GUSC questions review for study team. 2/3/26: GUSC reviewed on 1/21, awaiting decision. 2/12/26: Concept withdrawn from GUSC. New study number: S2611. Plan to resubmit to GUSC after CORE-008 data is released and incorporated into concept (submit by 4/22 for 5/20 review). Dr. Agarwal (GU EO) will present brief study updates to SWOG triage on 3/9. |
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| S2613 Assessing the need for Pelvic Lymphadenectomy at the time of Prostatectomy for Prostate Cancer with PSMA-PET based Evaluation: A Multicenter, Randomized Phase III Clinical Trial |
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Capsule Summary Approval Date: 03/12/2026
Current Status: Triage approved 3/12/26. Risk assessment complete. F&F scheduled for 4/23. Internal study team kickoff call currently being scheduled. IROC kickoff call will occur before GUSC submission. GUSC submission planned for May 20 (June 17 review date). |
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| Leukemia | ||
| S2504 A Randomized Phase III Study of PIRtobrutinib plus R-CHOP vs. R-CHOP for Patients with Previously UntreateD RIchter TrAnsforMation (RT) (pirAMID) |
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Capsule Summary Approval Date: 01/08/2024
Concept or Lol submit to NCI: 09/13/2024 Target Date: 08/05/2025 Drop Dead Date: 07/31/2026
Progress:
538
of 270 days
Current Status: 01/22/2024: Triage approval letter received. 02/09/2024: Internal Study Team Meeting. 03/05/2024: Risk Assessment. 03/05/2024: PRO proposal submitted for March review. 03/12/2024: PROCore Review & recommendations submitted. 03/26/2024: F&F call. 04/24/2024: Kick-off call with Eli Lilly 04/29/2024: Submitted to LKSC 05/06/2024: Notified of 6/14 LYSC review, reached out to clarify that it should be LKSC, pending response. 06/03/2024: Verified that concept will remain under the Leukemia Committee at SWOG but will be reviewed by the LYSC. 06/14/2024: LYSC review. Major comments received from LYSC on 7/10/24. Will need to revise and resubmit for August or September LYSC meeting. NCI Teleconference: 7/29. S2421 concept was withdrawn, edits made, new study # is S2504. S2504 concept submitted 9/13. Reviewed by LYSC on 11/08. Concept approval 12/5/2024. Protocol first draft sent 12/17/24. RaPID: 1/24/25 F/u RaPID: 3/3/25 Stats PRC 3/19/25. CTEP submission 4/18/25, Amy is now PPM for this study. 05/16/2025: FDA comments received. 05/20/2025: Responses to FDA comments submitted. 05/22/2025: Additional FDA comments received. 05/27/2025: Responses Submitted. 05/28/2025: FDA approval received. 06/12/2025: Consensus Review Received. 07/18/2025: Re-submitted to CTEP. 8/06/2025: Second Consensus review received. 08/28/2025: Re-submitted to CTEP. 09/10/2025: CTEP Approval on Hold received. 09/12/2025: Initial CIRB Application submitted. 10/16/2025: CIRB Review date. 10/23/2025: CIRB comments received. 11/05/2025: Response to CIRB review submitted with amended protocol 11/11/2025: CIRB Approval. 12/10/2025: Target activation is 2/16/2025. 01/05/2026: CTEP Approval on Hold received; pending Funding Sheet Approval and Pre-Activation Revision will be submitted by the end of the month. 01/30/2026: Pre-Activation revision submitted to CTEP. 02/17/2026: Consensus Review on Pre-Activation Revision received. 02/20/2026: Pre-Activation revision re-submitted to CTEP. 03/24/2026: CIRB approval for Pre-Activation revision received. 05/01/2026: Target Activation Date. |
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| S2507 A Phase II Randomized Study of Blinatumomab with or without Revumenib for Patients with KMT2Ar B-ALL with persistent measurable residual disease (MRD) |
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Capsule Summary Approval Date: 04/22/2024
Concept or Lol submit to NCI: 02/04/2025 Target Date: 10/19/2025 Drop Dead Date: 10/14/2026
Progress:
373
of 180 days
Current Status: 02/07/2023: Capsule approved by Triage. 02/28/2023: Risk assessment completed. 03/06/2023: F&F occurred. 03/28/2023: LKSC submission pending further study edits, COG review, and ALL working group meeting. 07/17/2023: TM capsule triage review. 07/26/2023: TM capsule triage approved. 07/31/2023: Study chairs working funding for TM and COG is reviewing capsules. 8/29/2023: LKSC submission. 09/21/2023: CTEP PRC occurred, awaiting consensus review. 10/16/2023: NCI OEWG call scheduled. 10/16/2023: NCI OEWG call cancelled, pending rescheduled date. 10/23/2023: NCI OEWG call occurred, LKSC submission withdrawn. 01/04/2024: Re-design sent COG for formal Scientific Council and Developmental Therapeutics Committee review. Also sent to EO for determination of need for Triage re-review. 01/25/2024: COG Scientific Council Review received, still pending Developmental Therapeutics Committee Review. 02/22/2024: COG Developmental Therapeutics Committee Review received. Study team is working through edits and responses. 02/29/2024: Awaiting triage submission approvals. 04/22/2024: Undergoing triage review. 04/22/2024: Assigned new study number of S2434. 05/02/2024: Pending internal study team kick-off call. 05/22/2024: Internal study team kick-off call. 07/01/2024: Pharma Kick-Off call with Syndax scheduled. 07/22/2024: Pharma Kick-Off call with Amgen scheduled. 07/29/2024: F&F Call occurred, study team is making modifications to the LOI, blinatumomab will now be be CIV only and commercially supplied. Accrual has changed to 52. 08/27/2024: LOI submitted to LKSC. 10/10/2024: LOI reviewed by PRC. 10/29/2024: CTEP Review on Hold pending response to comments and NCI conference call. 11/12/2024: NCI teleconference call occurred. 11/20/2024: LOI Withdrawn from CTEP. 01/03/2025: Re-design finalized. 01/27/2025: Presented at Triage by Dr. O'Brien as an FYI. Reassigned new study number S2507. 02/04/2025: Concept submitted to LKSC. 03/25/2025: Pending new LKSC review date. 05/02/2025: LKSC approval received. 05/19/2025: Initial protocol draft circulated to study team. 06/30/2025: RaPID call scheduled. 07/30/2025: Stats PRC occurred. 08/05/2025: Aiming to submit to CTEP beginning of September. 09/05/2025: Protocol submitted to CTEP. 10/23/2025: FDA comments received. 11/07/2025: Responses to FDA comments submitted. 11/13/2025: FDA placed a partial clinical hold on the study. 11/17/2025: Responses to FDA hold comment submitted. 11/24/2025: Responses to FDA non-hold comments submitted. 11/24/2025: Meeting with Syndax to discuss trial funding and support. 12/17/2025: FDA approval to proceed received, removal of partial clinical hold. 12/29/2025: CTEP Consensus Review received. 01/30/2026: Consensus Review responses submitted to CTEP. 03/24/2026: 2nd Consensus Review received. Pending resubmission of study team responses. |
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| S2603 A Phase II Study of Nuvisertib and Decitabine-Cedazuridine for Myelodysplastic/myeloproliferative neoplasms (MDS/MPNs) |
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Capsule Summary Approval Date: 08/18/2025
Concept or Lol submit to NCI: 02/25/2025 Target Date: 07/26/2026 Drop Dead Date: 07/21/2027
Progress:
93
of 180 days
Current Status: 08/19/2024: Capsule Approved by Triage. 09/06/2024: Internal Study Team Call scheduled, Pharma kick-off call and F&F pending scheduling. 10/01/2024: Pharma Kick-off Call with Sumitomo scheduled. 10/31/2024: Risk Assessment completed. 11/19/2024: F&F call occurred. 12/11/2024: Concept finalized. 01/24/2025: Sumitomo letter of support obtained. Feedback on Concept received and responses sent. 02/25/2025: Submitted to LKSC; may be reviewed by PRC. 03/13/2025: Scheduled for PRC Review. 03/17/2025: Disapproved by CTEP. 05/06/2025: Call with NCI for disapproval comments. 05/15/2025: Study redesign in progress. 08/18/2025: Reviewed at Triage as an FYI and assigned a new study number S2603 (formerly S2502). 09/23/2025: mini-F&F call. 10/21/2025: Concept submitted to CTEP. 01/27/2026: LKSC review. 02/19/2026: Handover meeting with Andrea. 02/26/2026: LKSC Consensus Evaluation Received. 03/10/2026: Resubmission of the updated Concept to LKSC. 03/16/2026: Updated Concept presented as FYI at Triage. 04/28/2026: Scheduled date of LKSC re-evaluation of Concept. |
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| Lung Cancer | ||
| S2608 Sequencing of IMmunOtherapy and chemoradiotherapy in unresectable stage III Non-small cell lung cancer (SIMON): A Randomized Phase III Study |
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Capsule Summary Approval Date:
Current Status: 5/21/26 - TMSC Re-review 2/26/26 - TMSC Review 1/7/26 - CTEP submission for TMSC review on 2/26/26 1/5/26 - Triage approval 12/22/25 - Triage FYI review 12/9/25 - Stats PRC review 7/26/25 - We are waiting to hear who will lead the study, SWOG or ECOG. 6/15/25 - Dr. Zhao drafted a revised Phase II/III Concept design that does not pause the study. SWOG wants to know who will run the study, if it will be SWOG or another cooperative group, before additional effort is used on this study. 6/3/25 - Study team met with CTEP on 5/22/25 to discuss the Consensus Review comments for the Concept. CTEP prefers the study use durva and they are flexible on Phase II/III for PFS go/no-go as long as there is no break in accrual or a Phase III study. Stats is reviewing different design options. Additional discussions with CTEP, Stats, and AZ will take place before a final design is determined. 5/5/25 - Coordinating follow-up call with CTEP, SWOG, and AZ to discuss revised Phase III Registrational Concept 4/25/25 - Study team call with AZ to propose a revised Phase III Registrational Concept 4/7/25 - Concept Disapproval 4/1/25 - Risk Assessment 3/20/25 - TMSC Review Meeting (outcome of review anticipated by mid-April) 2/13/25 - Submitted concept to PIO for TMSC review. 2/10/25 - Triage review and approval. Rushed to Triage since ECOG submitted a similar concept to TMSC. Previously S2509. TMSC review on 2/26/26. Scheduling F&F call in April 2026. |
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| S2612 A phase II study of atezolizumab and JBI-802 for previously treated extensive stage small cell lung cancer (SCLC) |
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Capsule Summary Approval Date: 03/16/2026
Concept or Lol submit to NCI: 03/27/2026
Current Status: 4/16/26: NCI PRC Review 3/27/26: LOI Submitted to CTEP 3/16/26: FYI Triage Review and Approval 8/6/25: TMSC Disapproval 7/17/25: TMSC Review 5/28/25: Concept submitted to CTEP. CTEP requested the addition of a references section, which has now been included. Resubmitted on 6/3 4/28/25: Sent updated concept to Jubilant and GNE to confirm they are still agreement to move study forward 1/31/25: Sent study team the updated Version 4.3 concept form for them to fill out and review 1/17/25: Internal meeting to discuss next steps 11/8/24: Meeting with Jubilant and Dr. Starodub, who shared insights on his experience with the drug and protocol. 8/26/24: Exec. Cmte/ Triage Approved Formally, S2503 and S2410. Concept was initially disapproved by CTEP due to drug company support withdrawal. TMSC reviewed updated S2503 concept and did not approve due to insufficient differentiation from prior LSD1 ICI data and a shifting therapeutic landscape. Now the current design differs from S2503 in that it is single arm design (instead of randomized) with a smaller sample size. The drug is still LSD1+HDAC6 inhibitor. |
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| LungMAP | ||
| S1900N A Randomized Phase II Study of Sacituzumab Govitecan alone, Ivonescimab alone, or Sacituzumab Govitecan and Ivonescimab in Participants with Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study) |
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Capsule Summary Approval Date: 07/15/2024
Concept or Lol submit to NCI: 01/24/2025 Target Date: 08/12/2025 Drop Dead Date: 08/07/2026
Progress:
441
of 180 days
Current Status: Absolute Deadline: 8/7/2026 4/7/2026 - Awaiting contract execution with both Gilead and Summit. 3/3/2026 - CIRB Approval on 2/28/2026. CIRB Approval pending modification on 2/11/2026. Letter revised on 2/18/2026. Re-submitted on 2/24/2026. 2/3/2026 - CIRB review expected to occur on 2/5. 1/6/2026 - CTEP approval on hold for CIRB review received 1/5 after submission on 12/23. Absolute deadline extended from 5/9 to 8/7/2026. 12/2/2025 - CTEP Review comments received 11/25. Pharma sent edits on 12/1 for their review by 12/10. 11/4/2025 - Re-submission occurred 10/17, outside of FDA review window, but recalled 10/20 due to needed edit. Submitted to CTEP on 10/24. Anticipated activation date changed to 2/1/26 from 12/1/25 due to government shutdown. 10/6/2025 - Re-submitted to CTEP on 9/9. Comments received on 9/24. ST made updates and sent to pharma for review on 9/26. Review is pending, was expected 10/3. 8/29/2025 - NCI call occurred on 8/14. ST made updates by 8/25. Ops sent to pharma for review on 8/26. 8/5/2025 - Consensus Review received 7/30. Study Team met to discuss on 7/31. NCI call to review comments scheduled for 8/14. 6/30/2025 - Initial Protocol CTEP Review submitted on 6/26. 6/2/2025 - Stats PRC held on 5/21. Review comments pending. SCC reviews received 5/29. 5/6/2025 - Stats PRC planned 5/21. Nationwide/FMI review expected 5/6. 3/31/2025 - RaPID call scheduled for 4/4. 3/21/2025 - CTEP Approval with Stipulations given 3/21. 3/4/2025 - NCI call held on 3/3 to discuss protocol stipulations. Protocol development underway. First draft to study team expected by 3/7. 2/25/2025 - Concept Approval On-Hold given from CTEP on 2/25. 2/13/2025 - CTEP consensus review held on 2/13. 1/29/2025 - F&F held on 1/22. Stats PRC held on 1/15. Concept submitted to CTEP on 1/24. Protocol development starting while concept review pending. 1/6/2025 - Met with collaborators on 12/19. NCI Pre-Look meeting held on 12/23. Call with collaborators planned for 1/9. Stats PRC scheduled for 1/15. F&F scheduling in progress. Official concept submission goal of 1/24. 12/2/2024 - CTEP Pre-Look comments received on 11/21. ST met on 11/25 to discuss and are currently updating concept. Collaborators updated on 11/25 that ST is reviewing. 11/4/2024 - ST incorporated Sponsor feedback and concept submitted for CTEP Pre-Look on 10/28. CTEP response expected mid-November. Internal risk assessment planned on 11/6. Gilead's main concerns: Timeline and budget. Summit's main concerns: data outcome for Ivonescimab. 10/23/2024 - Summit proposed change to a 3-arm design that includes an Ivo-only arm. Study Team discussed with Gilead/Summit and has sent them the new concept design for review on 10/22. 9/30/2024 - Concept draft submitted for pharma review on 9/13. Study Team working on Gilead's review comments and awaiting Summit's review. 8/30/2024 - Internal Kick off Call held 8/30. Concept draft still in development with Study Team. 8/14/2024 - Concept draft expected by 8/31 from study team. 8/5/2024 - Admin Kick-Off call held on 8/5 with both Gilead and Summit. Scientific Kick-off call scheduled for 8/9. Internal call for Concept development scheduled for 8/8. 7/30/2024 - Admin Kick-Off Call scheduled for 8/5. Scientific Kick-Off Call scheduled for 8/9. 7/22/2024 - Study Chair Welcome Letters were sent out on 7/18. Planner group has been set up and shared. DSC approved: 7/15/2024 |
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| S1900P A Randomized Phase II Study of Sapanisertib plus Serabelisib plus Paclitaxel Versus Standard of Care Chemotherapy in Participants with NFE2L2, KEAP1 or PI3K Pathway-Positive Stage IV or Recurrent Squamous Cell Lung Cancer (ECOG-ACRIN Lung-MAP Sub-Study) |
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Capsule Summary Approval Date: 06/06/2025
Current Status: 4/7/26 - Study team met with Faeth on 3/24/26 to discuss update to the study design. The study team is revising the concept and will send it to Faeth to review. 3/13/26 - Study team met with CTEP to discuss the pre-look comments. 3/9/26 - CTEP call to discuss pre-look comments was rescheduled due to the availability of key participants. 3/3/26 - Study team is addressing CTEP's feedback. Call with CTEP on 3/9/26 to discuss comments. 2/20/26 - CTEP pre-look comments received. 2/3/26 - CTEP indicated the pre-look will be reviewed this week. Comments anticipated by 2/13/26. 1/26/26 - Bypassing a Feasibility & Finance (F&F) Call. SAW sent to SWOG budgets/contracts/legal teams for review. Risk Assessment in progress. 1/13/26 - Concept submitted to CTEP for pre-look 1/12/26 - Study team responded to Faeth's feedback. Faeth provided approval to move forward with CTEP pre-look submission. 1/8/26 - Draft concept feedback received from Faeth. 1/6/26 - Faeth's feedback was originally due 12/17/25, but they have requested an extension and their feedback is now due 1/7/26. Once Faeth and Lung-MAP finalize the concept it will be submitted to CTEP for a pre-look. 12/1/25 - Draft concept sent to Faeth for review. Faeth's feedback is due 12/17/25. 11/21/25 - Company Kick-Off Call 11/4/25 - The study team is incorporating minor edits into the stats section of the concept. The document is expected to be finalized soon. Faeth will be given the opportunity to review prior to pre-look submission. CTEP will not review new concepts until the government shutdown ends. 10/6/25 - Internal Kick-Off Call 9/25/25 - Study Chair, Co-Chair, Champion confirmed their willingness to participate 9/23/25 - Study Chair, Co-Chair, Champion invitations sent 9/19/25 - Study team met with Faeth to discuss the budget and study design options. Faeth confirmed their willingness to support concept and protocol development. 9/7/25 - FNIH sent a high-level budget proposal to Faeth 8/11/25 - Study team and FNIH sent draft concept and budget estimate to Faeth 8/4/25 - Study team sent initial concept draft to FNIH and SWOG for the budget estimate to be drafted 6/6/25 - DSC Approved. DSC Approval Letter sent to Faeth. Faeth asked to review draft budget and design options before committing to move forward with study development. Anticipated activation Q4 2026/Q1 2027 |
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| S1900Q A Phase II Study of Zongertinib with Trastuzumab Deruxtecan in HER2 Dysregulated Relapsed/Refractory Advanced Non-Small Cell Lung Cancer (Alliance Lung-MAP Sub-Study) |
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Capsule Summary Approval Date: 10/03/2025
Current Status: 4/7/2026 - Pre-Look submitted on 3/10 after additional changes. Pre-Look comments returned 4/6. Study Team discussing CTEP comments requiring design changes. 3/3/2026 - Pre-Look submission made 2/27/2026 but withdrawn same day to make edits. Pre-Look submission expected by 3/4/2026. 2/3/2026 - Study Team made edits to concept. Given to BI for review on 2/2 ahead of pre-look submission. Review expected by 2/16. 1/6/26 - Dr. Redman is drafting the study design for the concept. The Company Kick-Off Call is scheduled for 1/23/26. 12/10/25 - Initial BI portal submission completed. The study team is actively discussing key elements of the study design and gathering data necessary to make informed decisions regarding accrual, accrual rate, interim analyses, and related operational considerations. These factors will directly inform the overall budget. 11/24/25 - Statistical design is being drafted. The accrual total is needed to generate a high level budget estimate for the BI portal. 11/14/25 - Internal call to discuss the study design 11/7/25 - Internal Kick-Off Call 10/31/25 - Study team met with Boehringer Ingelheim to discuss portal usage 10/29/25 - Study Chair, Co-Chair, Champion invitations sent and all confirmed their willingness to participate. The study team confirmed they are working on the concept. 10/27/25 - Boehringer Ingelheim confirmed their willingness to support concept and protocol development 10/4/25 - DSC approval letter sent to Boehringer Ingelheim 10/3/25 - DSC Approved Anticipated activation Q4 2026/Q1 2027 |
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| Lymphoma | ||
| S2506 MOZART MZL: A Randomized Phase II Study with a Common Control Arm of Mosunetuzumab Monotherapy Evaluated Against Two Experimental Treatment Arms of Either Combination Mosunetuzumab and Zanubrutinib or Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients with Relapsed/Refractory Marginal Zone Lymphoma |
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|
Capsule Summary Approval Date: 12/23/2024
Concept or Lol submit to NCI: 02/14/2025 Target Date: 10/08/2025 Drop Dead Date: 10/03/2026
Progress:
384
of 180 days
Current Status: 4/2/26: The revised protocol was resubmitted to CTEP. Target activation has been updated to 6/1. 3/24/26: Additional CTEP consensus review comments received. 3/11/26: FDA Study May Proceed letter received. 3/3/26: The FDA requested additional information. That information was provided on 2/25/26. Pending updates from CTEP regarding the revised protocol. 2/9/26: IND was submitted to the FDA. 2/6/26: The revised protocol was submitted to CTEP. 2/3/26: Anticipated resubmission to CTEP 2/5. Target activation updated to 5/1/26. 1/9/26: BeOne LOA received. Plan is to submit the version of the protocol resubmitted to CTEP to the FDA. 1/8/26: Consensus review comments received. 1/6/26: Working with both BeOne and GNE on additional protocol edits. BeOne to provide cross-reference letter as soon as possible after protocol approval. Pending CTEP consensus review comments. 12/9/25: OWEG drop dead date adjusted to 10/3/2026. Target activation now 3/16/26. 11/7/25: Protocol submitted to CTEP. Pending cross-reference letter from BeOne for FDA submission. 11/4/25: Had touchbase calls with BeOne (10/20) and GNE (11/3). Anticipated submission to CTEP this week. 10/7/25: Received approval from GNE and BeOne. Finalizing protocol for submission to CTEP. 8/20/25: Stats PRC 8/1/25: RaPID call. Stats PRC scheduled for 8/20. 7/21/25: Meeting with BeOne to discuss updated budget. BeOne will forward updated budget to internal review for approval; unsure when to expect a response, but is also much more comfortable with udpates. 7/18/25: Meeting with GNE to discuss updated budget. GNE more comfortable with new budget, will submit to internal review committee for approval. GNE anticipates providing a response to their review by end of August/early September. 7/10/25: Internal study team meeting to discuss budget items. Both pharma partners expressed concern about proposed budget. The study team has agreed to reduce the number of PROs administered from 3 to 1 and to reduce the number of timepoints from 5 to 3. Revised budgets submitted to pharma partners. July 2025: RaPID to be rescheduled due to scheduling conflicts 5/19/2025: Internal KOC; study team responses submitted to CTEP 5/12/2025: Study team call with CTEP 4/22/2025: Concept approved by CTEP 4/11/2025: Concept to be reviewed by steering committee 2/14/2025: Concept submitted 1/20/2025: Risk Assessment: 12/23/2024: Triage approved |
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| Melanoma | ||
| S2601 Multicenter Selective Lymphadenectomy Trial III: A randomized phase 3 , International, Multicentre, Randomised, Controlled Trial of Selective Index Lymph Node Resection versus Therapeutic Lymph Node Dissection after Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma |
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|
Capsule Summary Approval Date: 07/17/2025
Concept or Lol submit to NCI: 10/30/2025 Target Date: 10/20/2026 Drop Dead Date: 10/15/2027
Progress:
97
of 270 days
Current Status: 3/16/26: Had call with NCI. Study team plans to submit response to NCI comments this week. Scheduling a min F & F call. 2/20/26: NCI provided comments on concept with a pending vote for the concept. Study team has call with NCI scheduled for 3/9/26 to discuss comments. We have a draft response ready for submission. 2/3/2026: Pending CTEP decision on concept, on 1/23/2026 Pi presented at MSCSC Meeting, and responded to reviewers comments. 1/6/2026: no updates, pending CTEP review scheduled 1/23/2026. 12/2/2025: Concept is scheduled to be reviewed by CTEP 1/23/2026. 11/4/2025: Concept was submitted to CTEP 10/30/2025. 10/6/2025: Finalizing concept and MIA supporting documents (letter of commitment and NCI Questions for New International Organizations) for CTEP submission. 9/2/2025: F & F is scheduled for 9/5/2025. 7/17/2025: Concept Triage approved |
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| Myeloma | ||
| S2508 Phase II Study of Optimal Induction and MRD Driven Maintenance Therapy for Patients with Newly Diagnosed High-Risk Multiple Myeloma (HRMM) |
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|
Capsule Summary Approval Date: 02/25/2025
Concept or Lol submit to NCI: 06/30/2025 Target Date: 11/24/2025 Drop Dead Date: 11/19/2026
Progress:
287
of 130 days
Current Status: 02/25/2025: Capsule approved by Triage. 02/25/2025: Internal Study Team Kick off call scheduling pending. 03/19/2025: Internal Study Team Kick off call. 04/21/2025: Internal SWOG NOC and Janssen call to discuss TM funding. 05/12/2025: F&F Call scheduled. 05/28/2025: LOI finalized. 06/17/2025: JNJ determination to support the TM outside of CRADA. 06/30/2025: LOI submitted to PIO. 07/30/2025: PRC comments received, must be re-submitted, 08/13/2025. 08/29/2025: Requested submission extension, LOI re-submitted 08/29/2025. 10/03/2025: Review on Hold received; pending 10/14 resubmission of revised LOI. 10/14/2025: LOI resubmitted to CTEP. 12/15/2025: LOI received CTEP Approval On Hold. Full Approval will be issued once the Drug Commitment Letter is received from Janssen. 01/06/2026: The first draft of the protocol is being written. RaPID is scheduled for 03/25/26. 01/07/2026: Janssen submitted signed Drug Commitment Letter to PIO/CTEP 01/13/2026: LOI Received CTEP Full Approval 02/03/2026 - Study team is working on the protocol. Stats PRC is scheduled for 04/15/26. 03/03/2026 - Study team is working on the protocol in preparation for RaPID on 03/25/26. Stats PRC is scheduled for 04/15/26. Target initial submission of the protocol to CTEP 05/20/26. 03/25/2026 - RaPID 03/31/2026 - Informed Consent Review Call 04/07/2026 - The study team is updating the post-RaPID draft of the protocol and ICF in preparation for Stats PRC on 04/15/26. Target initial submission of the protocol to CTEP 05/20/26. 09/01/2026: Target Activation |
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| S2604 A Phase III Study for Evaluation of Maintenance Cessation in Patients with Standard Risk Myeloma Achieving Minimal Residual Disease Negativity |
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|
Capsule Summary Approval Date: 09/08/2025
Concept or Lol submit to NCI: 11/04/2025 Target Date: 01/02/2027 Drop Dead Date: 09/28/2027
Progress:
23
of 270 days
Current Status: 09/08/2025: Triage Approved. 09/26/2025: Internal study team kick off call. 10/29/2025: F&F call. 11/04/2025: Concept submitted to MYSC. 04/07/2026: NCI Steering Committee Review scheduled. |
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| myeloMATCH | ||
| MM1-S06 MM1-S06, A Phase 2 Study of Novel Agents with Venetoclax and the DNMT1 Inhibitor Cedazuridine-Decitabine for Newly Diagnosed Acute Myeloid Leukemia/Myelodysplastic Syndromes with TP53 Mutations (NAVIGATE-TP53): A MyeloMATCH Substudy |
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|
Capsule Summary Approval Date: 12/01/2025
Current Status: Risk Assessment pending. Approved by triage 12/1/25. Reviewed by triage 11/24/25. |
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| MM1OA-S04 A Phase 2 trial of ASTX727 with standard duration versus shorter duration of venetoclax in genomically heterogenous AML among adults aged 60 or older and less fit for intensive therapy: a myeloMATCH substudy. |
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|
Capsule Summary Approval Date: 03/10/2025
Concept or Lol submit to NCI: 03/24/2025 Target Date: 01/17/2026 Drop Dead Date: 10/14/2026
Progress:
373
of 270 days
Current Status: CIRB approval 3/26/26. FDA Consensus Review received 3/24/26. 2nd Submission to CIRB 3/20/26. CIRB meeting planned for 3/5/26. Submitted to CIRB 2/12/26. 3rd Submission to CTEP 1/9/26. 2nd Consensus Review received 12/30/25. 2nd Submission to CTEP 11/19/25. 2nd NCI OEWG Teleconference 11/18/25. Consensus Review received 09/10/25. Submitted to CTEP 8/19/25. Concept Approved 8/5/25. PRC review 7/16/25. RaPID Call 6/24/25. NCI OEWG Teleconference 5/29/25. Internal Kick Off 5/20/25. LKSC approval "on hold" pending drug commitment 5/1/25. F&F Call 4/24/25. LKSC reviewed 4/22/25. Concept submitted to CTEP 3/24/25. Risk Assessment (email) 3/21/25. Reviewed and approved by triage 3/10/25. |
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| MM1OA-S05 A RAS-Activated Biomarker Driven Phase II Study Evaluating Addition of Tuspetinib to CPX-351 Induction Therapy in Older Fit Adults with Acute Myeloid Leukemia: A myeloMATCH Substudy |
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|
Capsule Summary Approval Date: 06/12/2025
Concept or Lol submit to NCI: 07/24/2025 Target Date: 05/23/2026 Drop Dead Date: 02/17/2027
Progress:
247
of 270 days
Current Status: PRC planned for 4/22/26. RaPID Call 3/30/26. Concept Approved 2/12/26. NCI OEWG Teleconference 11/25/25. Approval On-Hold 09/16/25. LKSC review 8/26/25. Concept submitted to CTEP 7/24/25. F&F Call 7/11/25. Risk Assessment (email) 6/26/25. Reviewed and approved by triage 6/9/25. |
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| Palliative Care | ||
| S2415 Acupuncture to Decrease Symptom Burden in Patients with Metastatic Breast Cancer |
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|
Capsule Summary Approval Date: 09/11/2023
Concept or Lol submit to NCI: 06/24/2024
Current Status: 3/15/2026 - First-round reviews for the R01 resubmission are in and scored well (impact score 25, percentile 12), appearing to be in a fundable range this cycle. Overall feedback was positive, with only minor questions around endpoints and feasibility—nothing that seemed to significantly impact enthusiasm. We’ll look to DCP for guidance on next steps. 10/15/2025 - R01 Re submission 9/26/25 - Pitch the PAC review of concept 7/25/25- Submission not funded. Will discuss re-submission next cycle. 10/17/24: R01 was reviewed (Score 31, Percentile: 15.0) 6/4/24: R01 Re submission 10/5/23: R01 Submission 9/11/23: Triage as FYI 8/16/23: Stats PRC |
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| Prevention, Screening, and Surveillance | ||
| S2609 A Multicenter, Double-Blind, Placebo-Controlled Randomized Phase III Trial of Finasteride to Prevent Recurrence in Patients with Low-Grade Intermediate-Risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) |
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|
Capsule Summary Approval Date: 01/05/2026
Current Status: 4/7/26: Concept withdrawn in order be be on the Steering Committee June agenda. 4/2/26: Concept submitted.Reboot Rx hired a consultant to help weigh options for procurement of finasteride and placebo. There are 2 paths being explored. 3/2/26: Reboot Rx announced that their philanthropist approved support for this study. 2/19/26: Reboot Rx is meeting with Hetero (generic manufacturer of finasteride) to discuss possibility of drug supply for this study. |
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| SWOG CTP | ||
| 21CTP.BREAST01 Molecular assessment and identification of ctDNA and optimizing treatment for HR-positive, Her2-negative metastatic breast cancer |
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|
Capsule Summary Approval Date: 02/12/2025
Concept or Lol submit to NCI: 12/24/2024 Target Date: 08/04/2025 Drop Dead Date: 05/01/2026
Progress:
449
of 180 days
Current Status: 04/07/2026: Resubmission to the CTP ERC was completed on 03/20, with an approval-on-hold status received on 03/31. Currently addressing NCA and other budget items with collaborating companies. Note that the FDA and WCG IRB submissions are contingent on the execution of the main study contracts. 03/03/2026: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 02/03/2026: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 01/06/2026: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 12/02/2025: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. 11/04/2025: Resubmission to CTP ERC is currently delayed as we await the final reviews and sign-offs from the pharma companies on the revised protocol draft. We are also pending review feedback on the NCA that was submitted for review on 10/24. 10/06/2025: CTP ERC Review held on 09/16. ERC comments were received on 10/02. The study team is currently addressing the ERC comments, along with FDA and pharma comments. 09/03/2025: Stats PRC scheduled. 08/06/2025: RaPID call occurred. 07/01/2025: Start up agreement executed 6/16. Study Team working on first drafts of protocol and consent. 06/03/2025: CTP ERC has approved concept, and pending startup agreement execution. 05/06/2025: CTP ERC has approved concept, and pending startup agreement execution. 04/01/2025: CTP ERC has approved concept, and pending startup agreement execution. 03/04/2025: CTP ERC has approved concept, and pending startup agreement execution. 02/04/2025: Study Team is working on the updated CTP ERC responses. 01/07/2025: Submitted the responses to the CTP ERC on 12/12/24. 12/03/2024: The study team is working on CTP ERC responses. 11/01/2024: The study team is working on CTP ERC responses. 10/01/2024: Received CTP ERC Capsule Outcome Review Letter on 09/23/24. The study team is working on responses. 09/03/2024: CTP ERC reviewed the concept on 8/20, pending ERC review letter. 08/06/2024: The capsule will be presented to CTP ERC on 8/20 for their review. 07/01/2024: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 06/04/2024: The updated capsule and budget have been submitted to AZ. The study team is pending approval of the capsule/budget and ERC approval. 05/07/2024: Negotiation discussions are ongoing with one of the collaborators (AZ). The study team is pending collaborator approval of the capsule and ERC approval. |
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| 26CTP.LEUK02 APEX-MF, A Randomized Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib for Treatment-Naive, Cytopenic Myelofibrosis |
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|
Capsule Summary Approval Date: 09/23/2025
Concept or Lol submit to NCI: 09/16/2025 Target Date: 06/20/2026 Drop Dead Date: 03/17/2027
Progress:
219
of 270 days
Current Status: 03/13/2026: GSK granted approval of protocol documents. 03/12/2026: SWOG ERC granted Approval on Hold. 03/06/2026: Protocol and ICD resubmitted for SWOG ERC and GSK review. 03/02/2026: ERC response letter received with comments from SWOG ERC. 03/02/2026: Study Team responses submitted to GSK. 02/27/2026: GSK response received with comments. 02/20/2026: Protocol and ICD resubmitted for SWOG ERC and GSK review. 02/04/2026: ERC response letter received with comments from SWOG ERC and GSK. 01/16/2026: Protocol and ICD submitted for SWOG ERC and GSK review. 12/17/2025: Stats PRC occurred. 11/19/2025: ICD review occurred. 11/12/2025: RaPID call occurred. 10/31/2025: SWOG CTP ERC approval received. 10/27/2025: First draft of consent sent to study team. 10/17/2025: Study Team responses submitted to ERC. 10/14/2025: Protocol RaPID scheduled. 10/13/2025: First draft of protocol sent to study team. 10/03/2025: ERC letter circulated and start-up agreement executed. Protocol development underway. 09/23/2025: Underwent SWOG CTP ERC review, received approval with responses required. |
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| Symptom Management and Survivorship | ||
| S2435 Phase III Trial of an App-delivered Sleep Coaching Intervention in Post-Treatment Survivors of Diverse Cancers and their Bedroom Partners |
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|
Capsule Summary Approval Date:
Current Status: **R01 RE-SUBMISSION for July 2025** PRC review 5/8. PRO Core team reviewed 5/14. Triage informally approved on 5/13. Pat Mize determined no need for mini F&F. R01 submitted June 5th. Response expected Q4 of 2024. Reassigned to a special panel that will meet on 11/21. Initial result expected soon after and comments expected late December. 11/22/24: Received an impact score of 34, 19th percentile. Waiting on summary statement before resubmission. 01/08/25: Summary statements received. Planned resubmission for July 2025. 01/21/25: Study team call to re-group. Targeting aims submission to DCP beginning of March and 7/5/25 resubmission for R01. 04/01/25: No new updates. Still planning on 7/5/25 resubmission for R01. 06/03/25: Received NCI DCP approval to resubmit R01 in July. 07/01/25: R01 currently on-track for resubmission by 7/7 (7/5 is a Saturday). 07/02/2025: R01 was resubmitted. 11/4/2025: R01 still under review, no updates (gov't shutdown). 11/21/25: R01 will be reviewed on 1/16/26. 1/6/2026: R01 will be reviewed on 1/16/26. 2/3/2026: R01 not discussed at the review meeting (categorized as "competitive - not discussed"). Awaiting summary statement as of 1/21. 2/16/2026: Dr. Sun asked DCP if they can resubmit the concept again as a new R01 submission. 3/30/2026: Study Team decided to revisit the population and will resubmit R01 in October. |
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