| Protocol #: |
S1800E |
| Priority #: |
|
| Title: |
A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or without Cemiplimab for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study) |
| Disease Committee: |
LungMAP
|
| SCs: Drs. |
Saiama Waqar, M.D., Tianhong Li, M.D. |
| Notes: |
OEWG start date: 11/16/23
Drop Dead date: 5/9/25
4/25/24 - Initial protocol submission to CTEP
4/22/24 - Post-Stats PRC comments received from Regeneron
4/18/24 - SWOG and Regeneron met for their third planning call to prepare for the FDA formal meeting that is anticipated in mid-June.
4/11/24 - Updated post-Stats PRC protocol sent to Regeneron. Regeneron will need about 10 business days to review and provide comments. Initial protocol submission to CTEP anticipated in April.
4/9/24 - Stats PRC comments received from SDMC.
4/2/24 - Once Ops receives SDMC's Stats PRC edits, the protocol and consent will be updated and sent to Regeneron for review. Initial protocol submission to CTEP anticipated in April.
3/27/24 - Stats PRC
3/13/24 - RAPID
3/1/24 - Regeneron provided comments for the first protocol draft.
2/26/24 - Received CTEP Full Approval of Concept
2/20/24 - Regeneron signed and submitted the Drug Commitment Letter to CTEP.
2/15/24 - Updated first protocol draft sent to Regeneron for review. Their edits/comments are due 3/1/24.
2/6/24 - Study team comments for first protocol draft are being incorporated into the second draft. RAPID anticipated in March. The Regeneron legal team is of the understanding that NCI told Regeneron that execution of the CTPA would constitute the drug commitment and the Drug Commitment Letter as a stand-alone document for S1800E is not necessary. However, the signed Drug Commitment Letter is due to CTEP by 4/8/24. FNIH and the SWOG legal team are working to rectify the disconnect about what is required and when.
1/25/24 - First protocol draft sent to the study team for review. Edits/comments are due 2/1/24.
1/8/24 - The revised concept received Approval On Hold on 1/8/24. Full Approval of the concept is contingent upon CTEP's receipt of Regeneron's Drug Commitment Letter for cemiplimab.
12/5/23 - Regeneron is reviewing the revised phase II/III design and will provide their feedback to the Lung-MAP team in the coming week. If Regeneron approves this design, a revised official Concept will be submitted to CTEP in December. S1800E has not yet been added to the OEWG timeline.
11/27/23 - Call with Regeneron to review CTEP feedback and phase II/III design.
11/24/23 - Revised concept with phase II/III design sent to Regeneron.
11/21/23 - Received CTEP comments. CTEP stated they would not approve a straight phase III study without phase I and phase II data. CTEP suggested the study team modify the design to be a phase II/III.
11/16/23 - CTEP review of S1800E Concept and supplemental Study Design and Interim Analysis Plan.
11/15/23 - Study team submitted a S1800E Study Design and Interim Analysis Plan for CTEP review. This document supplements the S1800E Concept.
11/7/23 - Official Concept remains with CTEP. According to PIO, Phase III designs must be reviewed by TSMC. This does not align with the standard review procedure for Lung-MAP concepts. Ops has followed up with PIO/CTEP on a weekly basis to request the review date. After 4 weeks, a date still has not been identified.
10/30/23 - Feasibility & Finance Meeting
10/5/23 - Risk Assessment Call
10/3/23 - Scheduling Feasibility & Finance Meeting
9/21/23 - Official Concept with Phase III design submitted to CTEP
9/5/23 - SWOG Leadership has reviewed and approved the revised concept. The study team will meet with Regeneron on 9/18/23 to discuss Regeneron's review comments. Once Regeneron provides their approval the concept will be submitted to CTEP.
8/7/23 - The study team and Regeneron have agreed to move forward with a Phase III design. The concept is being updated in preparation for CTEP submission.
8/1/23 - The study team will meet with Regeneron again on 8/7/23 to continue discussing the statistical design.
7/11/23 - The study team had a call with Regeneron on 7/6/23. Their leadership team is supportive of the concept, but want to go back to assessing for primary endpoint in all-comers irrespective of PD-L1 status. They are still going back and forth on statistical issues (They want to increase the hazard ratio to 0.65 instead of 0.63 and sample size will probably need to go up to around 380). There is a follow up call on 7/17/23.
6/6/23 - Study team is meeting with Regeneron on 6/7/23 to discuss the study's updated statistical design.
5/2/23 - Study team met with Regeneron 5/1/23. Regeneron confirmed they will not support the study unless it is a Phase II/II and has the primary analyses population of PD-L1 >1%. The study team agreed to wait until Regeneron provides their internal review and approval of the Concept (planned for the end of May) before reaching out to CTEP again.
4/4/23 - Study has changed from a Phase II to a Phase II/III. Regeneron is interested in registrational intent. Last study call held 4/3/23. Regeneron is reviewing the concept and will have comments in the next 1-2 weeks. Study team is looking into eligibility updates.
3/6/23 - Call with CTEP scheduled for 03/09/23 to review pre-look comments. Still pending updates/edits from Regeneron on Concept. Study call scheduled for 03/09/23.
2/15/23 - Pre-look comments received from CTEP
2/7/23 - Revised Concept pending company review with feedback expected later this month. Revised Concept was submitted to CTEP for a second pre-look on 1/26/23. The study team will address CTEP's initial comments in conjunction with comments received from the company review and update the Concept in preparation for an initial submission.
1/26/23 - Revised Concept submitted to CTEP for pre-look
1/9/23 - Concept has been updated to include a stand-alone randomized Phase II design, and it has been sent to Regeneron for review.
9/8/22 - CTEP has put the pre-look on hold due to accrual concerns with Pragmatica.
7/22/22 - Concept Submitted to CTEP for pre-look
5/5/22 - Company KOC
4/1/22 - DSC approved |
I. CAPSULE SUMMARY:
It is the responsibility of the Study Coordinator to make sure that all capsule summary form requirements are completed prior to submission of the summary for executive review. (See Capsule Summary Template for requirements)
|
| Approval Date |
2022-04-01 |
| Comments |
4/1/22 - DSC Approved |
II. PROTOCOL DEVELOPMENT:
All of these steps must be completed before a protocol can be activated.
|
a. Letter of Intent:
Phase II w/NCI-supplied drug OR go to II.c
Applicable: Yes
|
| Primary Committee's Review |
Submission |
Approval
|
| |
|
|
| Comments |
|
b. Concept Submission Form:
Phase III only
Applicable: Yes
|
| Review |
Submission |
Approval |
| |
|
|
| Comments |
|
c. Initial Protocol Draft/Review:
This process may be repeated until the final protocol is drafted.
|
| Protocol Review |
Date/N/A |
| Study Coordinators/Committee Chair(s) |
|
| Statistical Center |
|
| Other Committee SCs (if needed) |
v |
| Drug Company (if needed) |
|
| Other Reviews |
|
| Draft Forms Inserted |
|
| Ops Consistency Check |
|
| NCI Protocol Submission Worksheet |
|
| PRC Review |
|
|
Intergroup CTSU:
QARC:
RPC:
|
| Comments |
3/13/24 - RAPID
3/1/24 - Received comments from Regeneron for first draft protocol
2/15/24 - Revised first draft protocol sent to Regeneron for review
1/25/24 - First draft protocol sent to the study team for review |
| d. Final Protocol Draft/Review: |
| Protocol Review |
Date/N/A |
| Study Coordinators/Committee Chair(s) |
|
| Statistical Center |
03/27/2024 |
| Others |
03/27/2024
|
CTEP/DCP
(copy for IND and contracts, if needed) |
| Submission: |
|
04/25/2024 |
| Consensus Review Received: |
|
|
| Consensus Review Response: |
|
|
| Approval on hold (if applicable): |
|
|
| Final Approval: |
|
|
|
CIRB
(if needed) |
| Submission: |
|
|
| CIRB Review Received: |
|
|
| CIRB Response Submitted: |
|
|
| Approval: |
|
|
|
| Final Ops Consistency Check |
|
| Final PRC Review (if needed) |
|
| Activation Amend (CTEP) |
|
| Final Forms Inserted |
|
| FFS Inserted |
|
| Activation Memo/HIPAA |
|
| Web Documents Prepared |
|
| Database Flags Set |
|
| Comments |
4/25/24 - Initial protocol submission to CTEP |
III. ADMINISTRATIVE:
(if needed) Contract and IND will be completed by Dir. of Ops and Pharm. Liaison.
|
| Budget for Drug Distribution |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Budget for Additional Support |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Budget for Correlative Studies |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Contract Signed |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| IND Assigned |
| Applicable? |
|
Date finalized |
| Yes |
|
|
|
| Other Last Minute Issues? |
Membership:
Intergroup:
Financial:
Correlates:
Drug Issues:
Other:
|
| Comments |
|
IV. ACTIVATION:
|
|
