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NCT06616584 · ClinicalTrials.gov registry record · Phase 2
Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 378
- Enrollment target
- 20
- Study locations
NCT06616584 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 378 participants, above the 94-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (302% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT06616584, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 378 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- BIOLOGICAL Cemiplimab
- DRUG Dexamethasone
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Tower Cancer Research Foundation - Beverly Hills
- Enloe Medical Center - Chico
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Fontana - Fontana
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- Kaiser Permanente-Fresno - Fresno
- Kaiser Permanente South Bay - Harbor City
- City of Hope at Irvine Lennar - Irvine
- Kaiser Permanente-Irvine - Irvine
Alabama
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis - Daphne
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland - Saraland
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alaska
- Katmai Oncology Group - Anchorage
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378 participants |
| Start Date | 2025-05-22 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06616584
The ClinicalTrials.gov registry entry for NCT06616584 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 378 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 94-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (302% higher). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06616584 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT06616584 about?
NCT06616584 is a clinical study titled "Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)". This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemi...
What is the current status of trial NCT06616584?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 378 participants. The study started on 2025-05-22. Estimated completion is 2028-12-31.
What conditions does trial NCT06616584 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 NCT06616584?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Cemiplimab (BIOLOGICAL), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT06616584?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06616584 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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