A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer
- Conditions
- Small Cell Lung Cancer
- Registration Number
- NCT06500026
- Lead Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 652
Inclusion Criteria:<br><br> 1. Voluntarily sign the informed consent and follow the requirements of the protocol;<br><br> 2. Age =18 years old;<br><br> 3. Expected survival time =3 months;<br><br> 4. Patients with recurrent small-cell lung cancer after failure of anti-PD-1/PD-L1<br> monoclonal antibodies and platinum-based chemotherapy;<br><br> 5. Consent to provide archival tumor tissue samples or fresh tissue samples of primary<br> or metastatic lesions within 3 years;<br><br> 6. Must have at least one measurable lesion according to RECIST v1.1 definition;<br><br> 7. ECOG 0 or 1;<br><br> 8. Toxicity of previous antineoplastic therapy has returned to = grade 1 defined by<br> NCI-CTCAE v5.0;<br><br> 9. No severe cardiac dysfunction, left ventricular ejection fraction =50%;<br><br> 10. The organ function level must meet the requirements on the premise that blood<br> transfusion is not allowed within 14 days before the screening period, and no cell<br> growth factor drugs are allowed;<br><br> 11. A serum pregnancy test must be performed within 7 days before the start of treatment<br> for premenopausal fertile women, and the result must be negative and must not be<br> lactating; All enrolled patients should take adequate barrier contraception during<br> the entire treatment cycle and for 6 months after the end of treatment.<br><br>Exclusion Criteria:<br><br> 1. The patient has histological or cytologic evidence of non-small cell lung cancer or<br> mixed components of small cell lung cancer/non-small cell lung cancer;<br><br> 2. Prior to randomization, chemotherapy, targeted therapy, or biological therapy were<br> used within 4 weeks or 5 half-lives, small molecule targeted therapy was used within<br> 5 days, or palliative radiotherapy was used within 2 weeks;<br><br> 3. Patients with recurrent small cell lung cancer who are eligible for curative local<br> therapy;<br><br> 4. Received chemotherapy with TOP I inhibitor;<br><br> 5. Received anti-EGFR and/or HER3 antibody /ADC drugs;<br><br> 6. History of severe heart disease or cerebrovascular disease;<br><br> 7. Unstable thrombotic events requiring therapeutic intervention within 6 months before<br> screening; Infusion-related thrombosis was excluded;<br><br> 8. Complete left bundle branch block, III degree atrioventricular block, frequent and<br> uncontrollable arrhythmia;<br><br> 9. Diagnosis of active malignancy within 3 years before randomization;<br><br> 10. Hypertension poorly controlled by two antihypertensive drugs;<br><br> 11. Patients with poor glycemic control;<br><br> 12. A history of ILD requiring steroid therapy, or current ILD or grade =2 radiation<br> pneumonitis;<br><br> 13. Complicated pulmonary diseases leading to clinically severe respiratory function<br> impairment;<br><br> 14. Patients with active central nervous system metastases;<br><br> 15. Severe infection within 4 weeks before randomization; There was evidence of<br> pulmonary infection or active pulmonary inflammation requiring clinical intervention<br> within 2 weeks before randomization;<br><br> 16. Patients with massive or symptomatic effusions or poorly controlled effusions;<br><br> 17. Imaging examination showed that the tumor had invaded or enveloped the large blood<br> vessels in the abdomen, chest, neck, and pharynx;<br><br> 18. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed<br> consent;<br><br> 19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4<br> weeks before signing the informed consent;<br><br> 20. Patients with inflammatory bowel disease, extensive bowel resection history, immune<br> enteritis history, intestinal obstruction, chronic diarrhea or Gilbert's syndrome;<br><br> 21. Patients with a history of allergy to recombinant humanized antibodies or to any of<br> the excipients of BL-B01D1;<br><br> 22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection<br> or hepatitis C virus infection;<br><br> 23. A history of severe neurological or mental illness;<br><br> 24. Subjects who were scheduled to receive live vaccine or received live vaccine within<br> 28 days before study randomization;<br><br> 25. Other circumstances that were assessed by the investigator as inappropriate for<br> participation in the trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS)
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS);Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DOR);Treatment Emergent Adverse Event (TEAE);Anti-drug antibody (ADA)