A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy
Overview
- Phase
- Phase 3
- Intervention
- BL-B01D1
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 698
- Locations
- 2
- Primary Endpoint
- Overall survival (OS)
- Status
- Active, not recruiting
- Last Updated
- 15 days ago
Overview
Brief Summary
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily sign the informed consent and follow the requirements of the protocol;
- •Age ≥18 years old;
- •Expected survival time ≥3 months;
- •Patients with histologically or cytologically confirmed locally advanced or metastatic EGFR wild-type non-small cell lung cancer;
- •Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
- •Must have at least one measurable lesion according to RECIST v1.1 definition;
- •ECOG 0 or 1;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- •The organ function level must meet the requirements on the premise that blood transfusion is not allowed within 14 days before the screening period, and no cell growth factor drugs are allowed;
Exclusion Criteria
- •Previous histological or cytological evidence of small cell or mixed small/non-small cell components;
- •Patients with EGFR L858R mutation, EGFR 19DEL mutation or EGFR T790M positive;
- •Chemotherapy, targeted therapy, biological therapy, etc., and palliative radiotherapy or antineoplastic therapy within 2 weeks before randomization;
- •Previous ADCs with TOPI inhibitors as toxins, antibodies/ADCs targeting EGFR and/or HER3;
- •History of severe heart disease or cerebrovascular disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Active malignancy diagnosed within 3 years before randomization;
- •Hypertension poorly controlled by two antihypertensive drugs;
- •Patients with poor glycemic control;
Arms & Interventions
BL-B01D1
Participants receive BL-B01D1 as intravenous infusion for 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.
Intervention: BL-B01D1
Docetaxel
Participants receive Docetaxel as intravenous infusion for 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.
Intervention: Docetaxel
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: Up to approximately 24 months
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Secondary Outcomes
- Duration of Response (DOR)(Up to approximately 24 months)
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)