Evaluation of Oral Paclitaxel, Immunotherapy, and SBRT Before Surgery in Older Adults with Resectable Stage IIA-IIIB Non-Small Cell Lung Cancer

What this Trial Is About

This trial focuses on patients aged 70 years or older with resectable stage IIA-IIIB non-small cell lung cancer NSCLC who do not have certain genetic alterations EGFR, ALK, ROS1. Researchers are evaluating a combination of oral paclitaxel solution, immune checkpoint inhibitors, and stereotactic body radiotherapy SBRT as a neoadjuvant treatment before surgery. The study aims to assess safety, tolerability, and preliminary effectiveness of this approach in older adults who may have higher risks from standard therapies. During Phase I, participants receive escalating doses of oral paclitaxel solution 80, 120, 160 mgm on Days 1 and 8 of each cycle, divided into morning and evening doses, combined with an anti-PD-1 or anti-PD-L1 monoclonal antibody and SBRT delivered as 8 Gy per fraction for 3 fractions. Phase II enrolls more participants at the recommended dose to further assess antitumor activity. Participants suitable for surgery after neoadjuvant therapy may undergo radical lung cancer surgery, while others receive definitive radiotherapy. Participants will undergo tumor response assessments through pathology and imaging, surgical evaluation if operable, and long-term follow-up for event-free and overall survival. Researchers will monitor treatment-related adverse events, pathologic complete response, and biomarker changes including immune cells, circulating tumor DNA, and PD-L1 expression. The study duration extends through treatment and follow-up until 2028, with careful safety and efficacy evaluations at multiple timepoints.

Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC