A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy

Sichuan Baili Pharmaceutical Co., Ltd.2 sites in 1 country722 target enrollmentAugust 7, 2024

ConditionsSmall Cell Lung Cancer

InterventionsBL-B01D1 Topotecan

DrugsBL-B01D1 Topotecan

Overview

Phase: Phase 3
Intervention: BL-B01D1
Conditions: Small Cell Lung Cancer
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment: 722
Locations: 2
Primary Endpoint: Overall survival (OS)
Status: Active, not recruiting
Last Updated: 15 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 7, 2024

End Date

December 1, 2026

Last Updated

15 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the informed consent and follow the requirements of the protocol;
•Age ≥18 years old;
•Expected survival time ≥3 months;
•Patients with recurrent small-cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy;
•Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
•Must have at least one measurable lesion according to RECIST v1.1 definition;
•ECOG 0 or 1;
•Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
•No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
•The organ function level must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period, and no cell growth factor drugs are allowed;

Exclusion Criteria

•The patient has histological or cytologic evidence of non-small cell lung cancer or mixed components of small cell lung cancer/non-small cell lung cancer;
•Prior to randomization, chemotherapy, targeted therapy, or biological therapy were used within 4 weeks or 5 half-lives, small molecule targeted therapy was used within 5 days, or palliative radiotherapy was used within 2 weeks;
•Patients with recurrent small cell lung cancer who are eligible for curative local therapy;
•Received chemotherapy with TOP I inhibitor;
•Received anti-EGFR and/or HER3 antibody /ADC drugs;
•History of severe heart disease or cerebrovascular disease;
•Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
•Complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
•Diagnosis of active malignancy within 3 years before randomization;
•Hypertension poorly controlled by two antihypertensive drugs;

Arms & Interventions

BL-B01D1

Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Intervention: BL-B01D1

Topotecan

Participants receive Topotecan as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Intervention: Topotecan