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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)

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 386 → 413 locations Eligibility criteria expanded, about 52 words · Secondary endpoints: details revised at 5 of 5 entries · Study description shortened, about 23 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description shortened, about 23 words
  2. Trial sites expanded: 361 → 386 locationsv7
  3. Study sites: 322 to 361v6
  4. Study sites: 239 to 322v5
  5. Study sites: 80 to 239v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date changed from estimate of Jul 11, 2025 to May 22, 2025v3
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 80v2 Show 1 more changeShow less
    • Study sites: 0 to 80
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06616584
Lead Sponsor SWOG Cancer Research Network
Collaborators: Regeneron Pharmaceuticals, National Cancer Institute (NCI)
Conditions Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Enrollment 378 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov