Phase II Study of Neoadjuvant and Adjuvant Multiple Therapies in Biomarker-selected Patients with Resectable Stages IB-III Non-small Cell Lung Cancer

What this Trial Is About

The trial investigates the effectiveness and safety of multiple therapies in participants with resectable stages IB, IIA, IIB, IIIA, or selected IIIB non-small cell lung cancer NSCLC tumors that meet specific biomarker criteria. This phase II study focuses on patients who have not been previously treated and aims to assess various targeted treatments based on tumor characteristics. Participants receive up to 8 weeks of neoadjuvant therapy with drugs such as alectinib, entrectinib, vemurafenib plus cobimetinib, pralsetinib, atezolizumab combined with stereotactic body radiation therapy SBRT, or divarasib before undergoing surgical resection according to standard care. After surgery, eligible participants with no disease progression or pathological response continue with adjuvant treatment, including chemotherapy cycles followed by up to 2 years of the respective study drug or other standard treatments depending on their cohort. Throughout the study, participants undergo clinical staging with CT, PET, and brain MRI scans, and evaluations including pathological response, adverse events, and survival outcomes. Researchers monitor tumor responses, disease-free and overall survival, and safety events for up to nine years. Treatment adherence, imaging, blood tests, and molecular analyses such as circulating tumor DNA clearance are part of the assessments during neoadjuvant, surgical, and adjuvant phases.

A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)