Skip to main content
Recurrent Lung Non-Small Cell CarcinomaDiagnostics and screeningCancerLungs and breathingProcedureBiologicalDrugPhase 2, Phase 3

What this study is

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.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Cemiplimab

    Intervention · BIOLOGICAL

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT

  • Dexamethasone

    Intervention · DRUG

    Given PO

  • Docetaxel

    Intervention · DRUG

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Ramucirumab

    Intervention · BIOLOGICAL

All of Cemiplimab, Docetaxel, Ramucirumab

Given IV

Study details

Official title
A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
Sponsor
SWOG Cancer Research Network
Conditions
Recurrent Lung Non-Small Cell Carcinoma · Stage IV Lung Cancer AJCC v8
Enrolling
378 people
Starts
2025-05-22
Est. completion
2028-12-31
Design
Open-label, randomized, parallel groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗