A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure
Overview
- Phase
- Phase 3
- Intervention
- Pemetrexed+Cisplatin or Carboplatin
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Enrollment
- 432
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- 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 non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure.
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;
- •Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer;
- •Documented classical EGFR mutations detected from tumor tissue or blood samples;
- •Had not received any systemic therapy other than EGFR-TKIs;
- •Radiographic disease progression documented during or after third-generation EGFR-TKI therapy for metastatic or locally advanced disease;
- •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 score 0 or 1;
Exclusion Criteria
- •The patient has histologic or cytologic evidence of small cell or mixed small/non-small cell component or squamous non-small cell lung cancer;
- •Chemotherapy, biological therapy, immunotherapy, etc., have been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy has been used within 5 days, palliative radiotherapy or anti-tumor therapy has been used within 2 weeks;
- •Previous treatment with: a. an ADC with TOPI inhibitor as toxin; b. any systemic therapy in the context of metastatic/locally advanced disease;
- •The history of severe cardiovascular and cerebrovascular diseases in the past six months prior screening;
- •Thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis more than 4 weeks later was excluded;
- •Complete left bundle branch block, III degree atrioventricular block, frequent and uncontrolled severe arrhythmia;
- •Other malignancies diagnosed within 3 years before randomization;
- •Hypertension poorly controlled by two antihypertensive drugs;
- •History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
- •Patients with poor glycemic control;
Arms & Interventions
Pemetrexed+Cisplatin or Carboplatin
Participants receive Pemetrexed +Cisplatin or Carboplatin in 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: Pemetrexed+Cisplatin or Carboplatin
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
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Secondary Outcomes
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)