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). 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 medic

Trial Details

NCT ID
NCT06616584
Phase
PHASE2 / PHASE3
Sponsor
SWOG Cancer Research Network
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Biospecimen Collection
  • Cemiplimab
  • Computed Tomography
  • Dexamethasone
  • Docetaxel
  • Magnetic Resonance Imaging
Locations (sample)
  • Daphne, Alabama, United States|30.60353,-87.9036
  • Fairhope, Alabama, United States|30.52297,-87.90333
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Saraland, Alabama, United States|30.82074,-88.07056
  • Anchorage, Alaska, United States|61.21806,-149.90028

Key Eligibility Criteria

  • Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S…
  • Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT m…
  • Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
  • Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III dis…

For full eligibility, visit ClinicalTrials.gov.

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