Phase 2 Study of Defactinib and Avutometinib Combined with Nivolumab for Treating Advanced LKB1-Mutant Lung Adenocarcinoma Not Responding to Anti-PD1 Therapy

What this Trial Is About

Researchers are evaluating how well a combination of defactinib, avutometinib, and nivolumab works in treating patients with LKB1-mutant non-small cell lung cancer that has not responded to prior anti-PD1 therapy. This phase II trial focuses on patients with advanced lung adenocarcinoma that may have spread locally or to distant parts of the body. The study aims to determine the progression-free survival at six months and also assess response rates, overall survival, and treatment side effects. Biomarker studies will be conducted using tumor samples from participants. Participants receive defactinib orally twice daily for 21 days, avutometinib orally twice weekly on specific days for 21 days, and nivolumab intravenously on day 1 of each 28-day cycle. Treatment cycles continue until disease progression or unacceptable side effects occur. During the study, patients undergo biopsies, blood sample collections, and imaging tests such as computed tomography CT or positron emission tomography PET to monitor the disease and treatment effects. After finishing study treatment, participants are followed up every three months for up to five years to monitor their health and disease status. Researchers will track progression-free survival, overall survival, duration of response, and adverse events throughout this period. The study involves regular assessments and monitoring to understand the impact of the drug combination on advanced lung adenocarcinoma.

Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer