OncoMatch/Clinical Trials/NCT06500026
A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer
Is NCT06500026 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BL-B01D1 and Topotecan for small cell lung cancer.
Treatment: BL-B01D1 · Topotecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Patients with recurrent small-cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy
Must have received: anti-PD-L1 therapy
Patients with recurrent small-cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy
Must have received: platinum-based chemotherapy
Patients with recurrent small-cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy
Cannot have received: chemotherapy
Exception: not within 4 weeks or 5 half-lives prior to randomization
chemotherapy, targeted therapy, or biological therapy were used within 4 weeks or 5 half-lives
Cannot have received: targeted therapy
Exception: not within 4 weeks or 5 half-lives prior to randomization; small molecule targeted therapy not within 5 days
targeted therapy...within 4 weeks or 5 half-lives, small molecule targeted therapy was used within 5 days
Cannot have received: biological therapy
Exception: not within 4 weeks or 5 half-lives prior to randomization
biological therapy were used within 4 weeks or 5 half-lives
Cannot have received: radiation therapy
Exception: not within 2 weeks prior to randomization
palliative radiotherapy was used within 2 weeks
Cannot have received: topoisomerase I inhibitor
Received chemotherapy with TOP I inhibitor
Cannot have received: anti-EGFR antibody
Received anti-EGFR and/or HER3 antibody /ADC drugs
Cannot have received: HER3 antibody
Received anti-EGFR and/or HER3 antibody /ADC drugs
Cannot have received: antibody-drug conjugate
Received anti-EGFR and/or HER3 antibody /ADC drugs
Lab requirements
Blood counts
Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; blood transfusion is not allowed within 14 days before the screening period, and no cell growth factor drugs are allowed
Kidney function
Liver function
Cardiac function
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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