Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05633602
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2022-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.
SECONDARY OBJECTIVE:
I. To summarize reports of serious and unexpected high-grade (\>= grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive chemotherapy per standard of care on study.
ARM B: Patients receive ramucirumab intravenously (IV) and pembrolizumab IV on study.
I. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.
SECONDARY OBJECTIVE:
I. To summarize reports of serious and unexpected high-grade (\>= grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive chemotherapy per standard of care on study.
ARM B: Patients receive ramucirumab intravenously (IV) and pembrolizumab IV on study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-09319 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| S2302 | OTHER | SWOG | View | |
| S2302 | OTHER | CTEP | View | |
| U10CA180888 | NIH | None | https://reporter.nih.gov/quic… | View |