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.
Inclusion Criteria:
Exclusion Criteria:
drtiantian@ustc.edu.cn
Participants with histologically or cytologically confirmed, unresectable stage IIIB to IV squamous non-small cell lung cancer(sqNSCLC) who are not candidates for definitive chemoradiotherapy and who have completed four cycles of first-line treatment with a PD-1 or PD-L1 inhibitor, a platinum agent, and paclitaxel or nab-paclitaxel without disease progression will receive metronomic oral paclitaxel plus maintenance immune checkpoint inhibition.
Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer(ES-SCLC) who have completed four cycles of first-line treatment with a PD-1 or PD-L1 inhibitor, a platinum agent, and etoposide without disease progression will receive metronomic oral paclitaxel plus maintenance immune checkpoint inhibition.
panyueyin@ustc.edu.cn+86-0551-65327751
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