Comparing Setidegrasib Versus Docetaxel for Adults with Advanced Non-small Cell Lung Cancer Having KRAS G12D Mutation Following Prior Chemotherapy and Immunotherapy

What this Trial Is About

Non-small cell lung cancer NSCLC is the most common lung cancer type, and this study focuses on people with NSCLC whose tumors have a specific faulty KRAS G12D gene mutation. Researchers are comparing a new drug called setidegrasib to the standard treatment docetaxel in adults with advanced or metastatic NSCLC who have already received chemotherapy and immunotherapy. The goal is to see if setidegrasib can help people live longer without their cancer worsening and to evaluate other effects on symptoms, tumor response, and safety. Participants in the study will be randomly assigned to receive either setidegrasib or docetaxel, both given through intravenous infusions. Setidegrasib is given on days 1, 8, and 15 of each 21-day cycle, while docetaxel is given on day 1 of each 21-day cycle. Treatment continues until the cancer progresses, side effects prevent continuation, or other stopping reasons occur. Some participants initially on docetaxel may switch to setidegrasib if their cancer worsens. Safety checks and monitoring occur regularly throughout the study. During the study, participants will have tumor scans every 6 weeks for the first year, then every 9 weeks until their cancer progresses. After progression, clinical staff will follow up by phone every 12 weeks. Researchers will assess how long participants live without cancer progression and overall survival, along with symptom changes, tumor response, quality of life, and side effects. The study may last up to several years, with ongoing evaluation of participant health and treatment effects.

A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation