A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07)

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 for Injection Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of BL-B01D1 in combination with tislelizumab versus platinum-based chemotherapy in combination with tislelizumab in first-line patients with extensive-stage small cell lung cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: BL-B01D1; Drug: Carboplatin; Drug: Tislelizumab; Drug: Etoposide

• Study Type: Interventional
• Enrollment (Estimated): 562
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
      • Contact: Qiming Wang
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai East Hospital
      • Contact: Caicun Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Age ≥ 18 years;
3. Expected survival time ≥ 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Patients with histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer;
6. Agree to provide archived tumor tissue specimens from the primary or metastatic lesions within 3 years, or fresh tissue samples;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
10. Organ function levels must meet the requirements;
11. Urinary protein ≤ 2+ or < 1000 mg/24h;
12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative; patients must not be breastfeeding. All enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.

Exclusion Criteria:

1. Pathology indicates small cell carcinoma containing non-small cell carcinoma components;
2. Patients who have previously received systemic treatment;
3. Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor;
4. Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug;
5. History of severe heart disease or cerebrovascular disease;
6. Receiving long-term systemic corticosteroid therapy at a dose >10 mg/day of prednisone or equivalent prior to the first dose;
7. Active autoimmune diseases and inflammatory diseases;
8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
9. Prolonged QT interval, complete left bundle branch block, etc.;
10. Diagnosis of active malignancy within 3 years prior to study randomization;
11. Hypertension inadequately controlled with two antihypertensive medications;
12. Poorly controlled diabetes mellitus;
13. History of interstitial lung disease (ILD)/pneumonitis requiring steroid therapy, etc.;
14. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;
15. Patients with active central nervous system (CNS) metastases;
16. Severe infection within 4 weeks prior to study randomization;
17. Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;
18. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;
19. Severe, non-healing wound, ulcer, or bone fracture within 4 weeks prior to signing informed consent;
20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
21. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea;
22. History of allergy to recombinant humanized antibodies or any excipient component of BL-B01D1;
23. History of autologous or allogeneic stem cell transplantation;
24. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
25. History of severe neurological or psychiatric disorders;
26. Receipt of other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;
27. Subjects planning to receive or having received live vaccines within 28 days prior to study randomization;
28. Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial due to complications or other circumstances.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BL-B01D1+Tislelizumab; Participants receive BL-B01D1+Tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.	Drug: BL-B01D1; Administration by intravenous infusion for a cycle of 3 weeks.; Other Names: BMS-986507; iza-bren; izalontamab brengitecan; Drug: Tislelizumab; Administration by intravenous infusion for a cycle of 3 weeks.
Active Comparator: Carboplatin+Etoposide +Tislelizumab; Participants receive Carboplatin+Etoposide +Tislelizumab in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.	Drug: Carboplatin; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Tislelizumab; Administration by intravenous infusion for a cycle of 3 weeks.; Drug: Etoposide; Administration by intravenous infusion for a cycle of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).	Up to approximately 24 months
Disease Control Rate (DCR)	Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.	Up to approximately 24 months
Duration of Response (DOR)	Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.	Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)	TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.	Up to approximately 24 months
Anti-drug antibody (ADA)	Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.	Up to approximately 24 months
Progression-free survival (PFS)	Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Coordination Complexes; Etoposide; Carboplatin; tislelizumab
• Other Study ID Numbers: BL-B01D1-314

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No