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A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)

NCT06500026 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2026-04-17

No results posted yet for this study

Summary

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent small cell lung cancer after failure of anti-PD-1/PD-L1 Monoclonal Antibodies and platinum-based chemotherapy.

Conditions

Interventions

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Topotecan

Administration by intravenous infusion for a cycle of 3 weeks.

Sponsors & Collaborators

  • Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Baili Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang · Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT06500026 on ClinicalTrials.gov