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A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer

NCT07802821 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 556

Last updated 2026-09-03

No results posted yet for this study

Summary

This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.

Conditions

  • Extensive-stage Small Cell Lung Cancer

Interventions

DRUG

QLC5508

QLC5508 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.

DRUG

QL2107

QL2107 will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for QL2107 will be 2 years.

DRUG

Tislelizumab

Tislelizumab will be administered intravenously once every 3 weeks. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for Tislelizumab will be 2 years.

DRUG

Carboplatin

Carboplatin will be administered intravenously once every 3 weeks. Carboplatin treatment will be administered for up to 4 cycles.

DRUG

Cisplatin

Cisplatin will be administered intravenously once every 3 weeks. Cisplatin treatment will be administered for up to 4 cycles.

DRUG

Etoposide

Etoposide will be administered intravenously once every 3 weeks. Etoposide treatment will be administered for up to 4 cycles.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-15
Primary Completion
2029-03-15
Completion
2030-06-15

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Entities

Drugs

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 NCT07802821 on ClinicalTrials.gov