The primary objectives of the study are:
* To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells
* To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells
The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
✓. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
✓. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
✓. At least 1 radiographically measureable lesion per RECIST 1.1
✓. ECOG performance status of ≤1
✓. Anticipated life expectancy of at least 3 months
✓. Adequate organ and bone marrow function
Exclusion criteria
✕. Patients that have never smoked, defined as smoking \<100 cigarettes in a lifetime
✕
What they're measuring
1
Overall survival (OS)
Timeframe: From date of randomization until the date of death, assessed up to 68 months
2
Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
. Active or untreated brain metastases or spinal cord compression
✕. Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
✕. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
✕. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to randomization
✕. Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
✕. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization
✕. Another malignancy that is progressing or requires treatment