Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.
PRIMARY OBJECTIVE:
I. To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care.
SECONDARY OBJECTIVE:
I. To summarize reports of serious and unexpected high-grade (>= grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive chemotherapy per standard of care on study.
ARM B: Patients receive ramucirumab intravenously (IV) and pembrolizumab IV on study.
Inclusion Criteria:
Exclusion Criteria:
Sacramento, California 95817, United States
West Haven, Connecticut 06516, United States
Washington D.C., District of Columbia 20002, United States
Deerfield Beach, Florida 33442, United States
Miami, Florida 33136, United States
Highland Park, Illinois 60035, United States
Brighton, Michigan 48114, United States
Chelsea, Michigan 48118, United States
East China, Michigan 48054, United States
Grosse Pointe Woods, Michigan 48236, United States
Macomb, Michigan 48044, United States
Norton Shores, Michigan 49444, United States
Warren, Michigan 48093, United States
Ypsilanti, Michigan 48197, United States
Columbus, Mississippi 39705, United States
New Albany, Mississippi 38652, United States
Lebanon, New Hampshire 03756, United States
Elizabeth, New Jersey 07207, United States
Harrisburg, Pennsylvania 17109, United States
Mechanicsburg, Pennsylvania 17050, United States
Mount Pleasant, Pennsylvania 15666, United States
North Huntingdon, Pennsylvania 15642, United States
Collierville, Tennessee 38017, United States
Vancouver, Washington 98684, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States