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)

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.

Primary Outcome

OS will be compared between arms and within the subgroups defined by the stratification factors and by PD-L1 subgroups. Distributions of OS will be estimated using the method of Kaplan-Meier. Hazard ratios for comparisons of OS will be estimated using a Cox Proportional Hazards regression model, with baseline hazard stratification using the stratification factors. Testing will be done using a stratified log-rank test. Confidence intervals (CIs) about medians will be estimated using the method of

Conditions Studied

Interventions

• PROCEDURE Biospecimen Collection
• PROCEDURE Computed Tomography
• DRUG Docetaxel
• BIOLOGICAL Cemiplimab
• DRUG Dexamethasone

Study Locations (20)