RecruitingPhase 4NCT07744698

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

Efficacy and Safety of Metronomic Oral Paclitaxel Plus an Immune Checkpoint Inhibitor as Maintenance Therapy After First-Line Induction in Advanced Squamous Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer: A Multicenter, Multi-Cohort Exploratory Study

Sponsor

Anhui Provincial Cancer Hospital

Enrollment

107 participants

Start Date

Jul 24, 2026

Study Type

INTERVENTIONAL

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)Squamous Non-Small Cell Lung Cancer sqNSCLC

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PD-1/PD-L1 inhibitor (eg. Tislelizumab) and a drug called Paclitaxel Oral Solution for people with extensive-stage small cell lung cancer (es-sclc) and squamous non-small cell lung cancer sqnsclc. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel Oral Solution

* Paclitaxel oral solution will be administered orally at 100 mg/m² per dose three times weekly, on Monday, Wednesday, and Friday, approximately 1 hour after a meal. * For Paclitaxel oral solution, treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. If dose reduction is required, the first reduced dose level will be 75 mg/m² per dose and the second reduced dose level will be 50 mg/m² per dose. Once the dose has been reduced, dose re-escalation will not be permitted.

DRUGPD-1/PD-L1 inhibitor (eg. Tislelizumab)

The appropriate PD-1/PD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, eg. Tislelizumab, Pembrolizumab, Camrelizumab and Penpulimab, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert. The maintenance PD-1/PD-L1 inhibitor should generally be the same agent used during first-line induction treatment.