Oral Paclitaxel with PD-1PD-L1 Inhibitor as Maintenance Therapy for Advanced Squamous Non-Small Cell and Extensive-Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of metronomic oral paclitaxel combined with a PD-1 or PD-L1 inhibitor as maintenance therapy in patients with advanced lung cancer who have not experienced disease progression after first-line chemoimmunotherapy. The study focuses on two groups one with advanced squamous non-small cell lung cancer and another with extensive-stage small cell lung cancer. This phase 4, open-label study aims to find better maintenance treatment options for these patients. Participants will receive oral paclitaxel at a dose of 100 mgm2 three times a week alongside the same immune checkpoint inhibitor used during their initial therapy, typically administered every three weeks. Treatment will continue until disease progression, unacceptable side effects, consent withdrawal, or other criteria for stopping are met. Two cohorts will be analyzed independently without direct comparison between them. During the study, participants will have tumor assessments approximately every six weeks and safety evaluations every three weeks. Researchers will measure progression-free survival as the primary outcome and also track tumor response, overall survival, adverse events, treatment tolerability, and quality of life. Additional exploratory analyses will include biomarker studies and immune-related factors. The total participation may last up to 36 months, with regular monitoring throughout.

Metronomic Oral Paclitaxel Plus PD-1/ PD-L1 Inhibitor Maintenance in Advanced Lung Cancer (PULSE Study)