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

NCT07744698 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Paclitaxel 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.

DRUG

PD-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.

Sponsors & Collaborators

  • Anhui Provincial Cancer Hospital

    lead OTHER

Principal Investigators

  • Yueyin Pan, MD, PhD · Anhui Provincial Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-24
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744698 on ClinicalTrials.gov