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NCT05633602 · ClinicalTrials.gov registry record · Phase 3
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study
A Phase 3 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 3
- Development phase
- 838
- Enrollment target
- 20
- Study locations
NCT05633602: Active Phase 3 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, sponsored by SWOG Cancer Research Network.
NCT05633602 is a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 838 participants, above the 88-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (852% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05633602, a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 838 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Assessed in participants with stage IV or recurrent non-small cell lung cancer with acquired resistance to anti-PD-1 or anti-PD-L1 therapy randomized to ramucirumab and pembrolizumab or standard of care chemotherapy. Will use an intention-to-treat analysis and the comparison will be done using a stratified log-rank test. The distribution of overall survival will be estimated using the method of Kaplan-Meier and a Cox proportional hazards model will be used to estimate hazard ratios and associate
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Chemotherapy
- BIOLOGICAL Ramucirumab
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Tower Cancer Research Foundation - Beverly Hills
- Marshall Cancer Center - Cameron Park
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
Arkansas
- Highlands Oncology Group - Fayetteville - Fayetteville
- Mercy Hospital Fort Smith - Fort Smith
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
- Highlands Oncology Group - Springdale
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 838 participants |
| Start Date | 2023-03-14 |
| Est. Completion | 2028-03-15 |
| Phase | Phase 3 |
What the registry record for NCT05633602 still lists
NCT05633602 is an interventional study that assigns participants to a tested intervention. The registered 838 participants enrollment target is mid-sized for trials with a published cap, above the 88-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (852% higher).
The record links to 2 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05633602 names 20 study sites across 4 states, led by California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT05633602 about?
NCT05633602 is a clinical study titled "Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study". 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 tha...
What is the current status of trial NCT05633602?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 838 participants. The study started on 2023-03-14. Estimated completion is 2028-03-15.
What conditions does trial NCT05633602 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT05633602?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Chemotherapy (DRUG), Ramucirumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05633602?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05633602 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05633602's enrollment target sits among peer trials
838 1st of 81 higher than 81 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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