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)

NCT07502300 | Not Yet Recruiting Phase 3

• 1 other identifier: BL-B01D1-314
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression-free survival (PFS)

  Up to approximately 24 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (2)

BL-B01D1+Tislelizumab

EXPERIMENTAL

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; Drug: Tislelizumab

Carboplatin+Etoposide +Tislelizumab

ACTIVE COMPARATOR

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: Tislelizumab; Drug: Carboplatin; Drug: Etoposide

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

BL-B01D1+Tislelizumab

Tislelizumab DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1+Tislelizumab; Carboplatin+Etoposide +Tislelizumab

Carboplatin DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Carboplatin+Etoposide +Tislelizumab

Etoposide DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Carboplatin+Etoposide +Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Age ≥ 18 years;
• Expected survival time ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Patients with histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer;
• Agree to provide archived tumor tissue specimens from the primary or metastatic lesions within 3 years, or fresh tissue samples;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
• Organ function levels must meet the requirements;
• Urinary protein ≤ 2+ or \< 1000 mg/24h;
• 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.

You may not qualify if:

• Pathology indicates small cell carcinoma containing non-small cell carcinoma components;
• Patients who have previously received systemic treatment;
• Previous treatment with ADC drugs where the small molecule toxin is a topoisomerase I inhibitor;
• Use of immunomodulatory drugs within 14 days prior to the first dose of the study drug;
• History of severe heart disease or cerebrovascular disease;
• Receiving long-term systemic corticosteroid therapy at a dose \>10 mg/day of prednisone or equivalent prior to the first dose;
• Active autoimmune diseases and inflammatory diseases;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;
• Prolonged QT interval, complete left bundle branch block, etc.;
• Diagnosis of active malignancy within 3 years prior to study randomization;
• Hypertension inadequately controlled with two antihypertensive medications;
• Poorly controlled diabetes mellitus;
• History of interstitial lung disease (ILD)/pneumonitis requiring steroid therapy, etc.;
• Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;
• Patients with active central nervous system (CNS) metastases;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tislelizumab; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (2)