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A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer

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

NCT06500026•Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the informed consent and follow the requirements of the protocol;
•2. Age ≥18 years old;
•3. Expected survival time ≥3 months;
•4. Patients with recurrent small-cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy;
•5. Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
•6. Must have at least one measurable lesion according to RECIST v1.1 definition;
•7. ECOG 0 or 1;
•8. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
•9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
•10. 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;
+1 more criteria

Exclusion Criteria

•1. 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;
•2. 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;
•3. Patients with recurrent small cell lung cancer who are eligible for curative local therapy;
•4. Received chemotherapy with TOP I inhibitor;
•5. Received anti-EGFR and/or HER3 antibody /ADC drugs;
•6. History of severe heart disease or cerebrovascular disease;
•7. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
•8. Complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
•9. Diagnosis of active malignancy within 3 years before randomization;
•10. Hypertension poorly controlled by two antihypertensive drugs;
+15 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

August 7, 2024

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

May 2, 2025

Enrollment

714

ESTIMATED participants

Conditions

Small Cell Lung Cancer

Interventions

BL-B01D1

DRUG

Topotecan

DRUG

Contacts

Sa Xiao, PHD

CONTACT

15013238943 xiaosa@baili-pharm.com

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Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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