InTRAPid

A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

Objective

The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.

Study Arms

• Experimental: M7824
• Active Comparator: Pembrolizumab

Eligibility

• Histologically confirmed diagnosis of advanced NSCLC
• Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease
• Have measurable disease based on RECIST 1.1
• Have a life expectancy of at least 3 months
• Availability of either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
• PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay

NCT ID

NCT03631706