Study of Pembrolizumab With or Without Chemotherapy and Investigational Agents in Adults With Stage IV Non-Small Cell Lung Cancer NSCLC

What this Trial Is About

Researchers are evaluating the effectiveness and safety of pembrolizumab MK-3475 alone or combined with chemotherapy and investigational agents including vibostolimab MK-7684, boserolimab MK-5890, MK-4830, MK-0482, Ifinatamab Deruxtecan I-DXd, and HER3-DXd. This study focuses on treatment-naive adults with advanced Stage IV squamous or non-squamous non-small cell lung cancer NSCLC. It is part of a larger pembrolizumab umbrella master protocol called KEYMAKER-U01. Participants receive pembrolizumab intravenously every three weeks, combined with chemotherapy agents like carboplatin, paclitaxel, or pemetrexed depending on cancer type and investigational agents according to their assigned study group. Initial treatment cycles last about 12 weeks followed by maintenance therapy continuing up to approximately two years. Some groups receive doses of investigational agents at different intervals, and treatments may escalate or stop based on disease progression or side effects. During the study, participants undergo various assessments including tumor response evaluations using RECIST 1.1 criteria, safety monitoring for adverse events, and laboratory tests to measure drug concentrations. Regular visits occur throughout treatment for monitoring effects and side effects. The studys main outcomes include measuring objective response rates, adverse events, treatment discontinuations, and dose-limiting toxicities over periods up to 27 months. Participants may remain in the study for up to about two years or longer depending on treatment duration and follow-up requirements.

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)