Phase II Study of New Drug Combinations for Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating novel combination treatment options for adults with locally advanced or metastatic Non-Small Cell Lung Cancer NSCLC in this Phase II, multi-center, open-label study. The trial includes several sub-studies focused on specific NSCLC populations based on genomic alterations and PD-L1 expression levels. The study aims to assess the safety, tolerability, and preliminary antitumor activity of various drug combinations across approximately 80 centers worldwide. Participants will receive one of three investigational drug combinations administered by intravenous infusion rilvegostomig with or without ramucirumab for first-line NSCLC with non-actionable genomic alterations and varying PD-L1 expression levels, or Dato-DXd combined with ramucirumab with or without rilvegostomig for later-line NSCLC with actionable genomic alterations. Treatments continue until disease progression, unacceptable side effects, or withdrawal from the study. Each sub-study may include initial safety run-in cohorts followed by dose expansion cohorts. Throughout the study, participants will undergo regular evaluations including tumor imaging to assess response, clinical safety monitoring, and laboratory testing. Researchers will measure outcomes such as adverse events, objective response rates, progression-free survival, and overall survival over an average of three years. Pharmacokinetics and immunogenicity of the study drugs will also be monitored. Participation involves ongoing treatment and follow-up visits until study completion or discontinuation.

A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)