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A Prospective, Multicenter, Randomized Controlled Study on the Efficacy and Safety of Low-dose Carboplatin Combined With Nab-Paclitaxel and Delayed Administration of Serplulimab as First-line Treatment for Advanced Squamous Non-small Cell Lung Cancer

NCT07647094 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-06-15

No results posted yet for this study

Summary

This study is a multicenter randomized controlled clinical trial targeting subjects with advanced or metastatic squamous NSCLC with unknown or negative gene status, aiming to evaluate the efficacy and safety of first-line delayed administration of Serplulimab combined with a low-dose Nab-Paclitaxel doublet chemotherapy regimen.

Conditions

Interventions

DRUG

Serplulimab, Nab-Paclitaxel, Carboplatin

Standard Dose Group (Control Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 260 mg/m², carboplatin AUC5, and serplulimab 4.5 mg/kg. Low Dose Group (Experimental Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 195 mg/m², carboplatin AUC3.75, and intravenous infusion of serplulimab 4.5 mg/kg on the third day.

Sponsors & Collaborators

  • People's Hospital of Quzhou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07647094 on ClinicalTrials.gov