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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)

ConditionExtensive-stage Small-cell Lung Cancer
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • BL-B01D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Tislelizumab

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Carboplatin

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Etoposide

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

562 Participants
are divided into 2 treatment groups
Group A: BL-B01D1+TislelizumabExperimental treatment 2 interventions
Group B: Carboplatin+Etoposide +TislelizumabActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

Time frame
Up to approximately 24 months

Secondary outcomes

1

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.

Time frame
Up to approximately 24 months
2

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).

Time frame
Up to approximately 24 months
3

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.

Time frame
Up to approximately 24 months
4

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.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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