NCT04591123

NCT04591123 is a clinical trial identifier for a study investigating the safety and efficacy of nivolumab in combination with chemotherapy for the treatment of resectable stage III non-small cell lung cancer. The trial, also known by its short title "CheckMate 77T," aims to determine if this combination therapy can improve event-free survival in patients who are candidates for surgery.

The study is a randomized, double-blind, placebo-controlled trial. Participants are assigned to one of two treatment arms: one receiving nivolumab plus chemotherapy followed by surgery and then nivolumab alone, and the other receiving placebo plus chemotherapy followed by surgery and then placebo alone. The primary endpoint is event-free survival, which is defined as the time from randomization until disease progression, recurrence, or death from any cause. Secondary endpoints include overall survival, pathological complete response, and major pathological response.

The trial is being conducted across multiple sites globally. Eligibility criteria include patients with histologically confirmed stage III (non-metastatic) non-small cell lung cancer, who are candidates for surgical resection and have not received prior systemic treatment for their current lung cancer. The study is sponsored by Bristol Myers Squibb. The first participant was enrolled in October 2020.