This trial is a registrational randomized, open-label, multicenter Phase II/III study designed to evaluate the efficacy and safety of BL-B01D1 in combination with a PD-1/VEGF bispecific antibody in patients with locally advanced or metastatic non-squamous non-small cell lung cancer.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Age ≥ 18 years;
Expected survival time ≥ 3 months;
Patients with locally advanced non-squamous non-small cell lung cancer;
Presence of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma components, or squamous carcinoma components exceeding 10%;
Evidence suggesting the presence of EGFR-sensitive mutations, etc.;
Patients who have received prior systemic therapy;
Prior receipt of therapies targeting the mechanism of tumor immunity;
Parallel
BL-B01D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
PD-1/VEGF Bispecific Antibody
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Tislelizumab
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Pemetrexed
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Carboplatin
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Cisplatin
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Phase II: 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).
Phase II: Investigator-assessed Progression-free Survival (PFS)
Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.
Phase III: BICR-assessed 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.
Phase III: Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Phase II/III: 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.
Phase II/III: 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.
Phase II/III: 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.
Phase III: 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.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
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