Phase 2 Study of Rina-S as a Single Treatment for Adults with Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and behavior of Rina-S when used alone in people with locally advanced or metastatic non-small cell lung cancer NSCLC, specifically adenocarcinoma type. The study is a Phase 2, open-label trial involving about 240 participants across multiple countries. It includes participants with or without certain genetic changes in their cancer. The purpose is to understand how well Rina-S works against lung cancer, with no placebo group, and all participants receive the active drug. Participants will receive Rina-S by intravenous infusion as a single treatment. The treatment duration varies, with an average expected around 12 months. Treatment cycles last 3 weeks, and for each cycle, participants may attend between 1 to 5 clinic visits. If the cancer remains stable or improves without serious problems, participants can continue treatment as long as the study is ongoing. Multiple cohorts receive the drug as monotherapy. During the study, participants will attend site visits for various tests including blood draws, heart activity monitoring, and imaging such as X-rays to check treatment safety and effectiveness. Researchers will measure outcomes like tumor response rate, duration of response, disease control, progression-free survival, and overall survival over approximately 3 to 4 years. Pharmacokinetic and immunogenicity assessments will also be done during about 12 months. The total study period lasts until late 2028, with ongoing safety monitoring throughout.

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer