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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)
NCT06616584 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 378 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06616584 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06616584?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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