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)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • BL-B01D1
  • Tislelizumab
  • Carboplatin
  • Etoposide

Treatment groups

562 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator