This trial is a registrational Phase II/III randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1/VEGF bispecific antibody in first-line patients with locally advanced or metastatic 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 or metastatic squamous non-small cell lung cancer;
Prior histological or cytological evidence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
Indications of the presence of EGFR-sensitive mutations, among others;
Patients who have received prior systemic therapy;
Prior treatment with agents targeting the mechanism of tumor immune action;
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.
Paclitaxel
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Carboplatin
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Phase II: Investigator-assessed 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 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 II/III: Progression-free Survival (PFS)
Progression-free Survival (PFS) is defined as the time from randomization or start of treatment until the first documented evidence of disease progression or death from any cause, whichever occurs first.
Phase II/III: 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/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.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
