Clinical Trial

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

Study acronym: PULSE
Recruiting Phase 4
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Summary
This study will evaluate the efficacy and safety of metronomic oral paclitaxel combined with a PD-1 or PD-L1 inhibitor as maintenance therapy in patients with advanced lung cancer whose disease has not progressed after first-line chemoimmunotherapy. The study will include two independently analyzed cohorts. Cohort A will include patients with advanced squamous non-small cell lung cancer(sqNSCLC), and Cohort B will include patients with extensive-stage small cell lung cancer(ES-SCLC). All participants will receive oral paclitaxel three times weekly together with the same immune checkpoint inhibitor used during first-line induction therapy, whenever feasible. The primary outcome is progression-free survival. Other outcomes include tumor response, overall survival, adverse events, treatment tolerability, and quality of life. Approximately 107 participants will be enrolled across multiple study centers.
Trial Details
NCT Number NCT07744698
Lead Sponsor Anhui Provincial Cancer Hospital
Conditions Squamous Non-Small Cell Lung Cancer sqNSCLC, Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Enrollment 107 participants
Start Date 2026-07-24
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-04