Comparing BL-B01D1 with Topotecan for 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

This study is testing whether a new treatment called BL-B01D1 works better than the standard drug Topotecan for people with recurrent small cell lung cancer who haven't responded to other therapies.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 714 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06500026 on ClinicalTrials.gov

What this trial studies

This phase III, randomized, open-label, multicenter trial evaluates the efficacy and safety of BL-B01D1 in patients with recurrent small cell lung cancer who have previously failed anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy. Participants will be randomly assigned to receive either BL-B01D1 or Topotecan. The study aims to determine which treatment provides better outcomes for patients with this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent small cell lung cancer after failing prior treatments.

Not a fit: Patients who have not experienced failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients with recurrent small cell lung cancer.

How similar studies have performed: Other studies have explored treatments for small cell lung cancer, but the specific approach of using BL-B01D1 is novel and has not been extensively tested.

Eligibility criteria

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;
11. A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal fertile women, and the result must be negative and must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

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;
11. Patients with poor glycemic control;
12. A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
13. Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
14. Patients with active central nervous system metastases;
15. Severe infection within 4 weeks before randomization; There was evidence of pulmonary infection or active pulmonary inflammation requiring clinical intervention within 2 weeks before randomization;
16. Patients with massive or symptomatic effusions or poorly controlled effusions;
17. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
18. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
20. Patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction, chronic diarrhea or Gilbert's syndrome;
21. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
23. A history of severe neurological or mental illness;
24. Subjects who were scheduled to receive live vaccine or received live vaccine within 28 days before study randomization;
25. Other circumstances that were assessed by the investigator as inappropriate for participation in the trial.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Li Zhang — Sun Yat-sen University
• Study coordinator: Sa Xiao, PHD

Conditions: Small Cell Lung Cancer