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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer (NCT06437509) is a Phase 2 interventional studying Extensive-stage Small-cell Lung Cancer, sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Extensive-stage Small-cell Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 66 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Extensive-stage Small-cell Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subject volunteered to participate in the study and signed an willing to sign a consent form; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG score 0-1; 5. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology; 6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient 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. Who Should NOT Join This Trial: 1. Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors; 2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer; 3. Pathology suggested small cell carcinoma containing non-small cell carcinoma components; 4. Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ; 5. Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ; 6. QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ; 7. Active autoimmune conditions (where your immune system attacks your own body)s and inflammatory diseases ; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Subject volunteered to participate in the study and signed an informed consent; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG score 0-1; 5. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology; 6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient 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. Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors; 2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer; 3. Pathology suggested small cell carcinoma containing non-small cell carcinoma components; 4. Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ; 5. Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ; 6. QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ; 7. Active autoimmune diseases and inflammatory diseases ; 8. Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose; 9. Other malignancies that have progressed or require treatment within 5 years prior to the first dose; 10. Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening; 11. Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis; 13. Concurrent pulmonary disease leading to severe clinical impairment of respiratory function; 14. Patients with active central nervous system metastases; 15. Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions; 16. History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks; 20. Have participated in another clinical trial within 4 weeks prior to the first dose; 21. Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders; 22. Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest; 23. Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy; 24. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy; 25. Subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose; 26. Other conditions that the investigator considers unsuitable to participate in this clinical trial.

Treatments Being Tested

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

PD-1 monoclonal antibody

Administration by intravenous infusion for a cycle of 3 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shanghai East Hospital
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06437509), the sponsor (Sichuan Baili Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06437509 clinical trial studying?

This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06437509?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06437509?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06437509. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06437509. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.