About this trial
This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.
Eligibility criteria
Qualifiers
Voluntarily sign informed consent and agree to comply with the protocol requirements;
Aged ≥18 years and ≤75 years, regardless of gender;
Expected survival time ≥3 months;
Patients with non-small cell lung cancer;
Disqualifiers
SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;
Trial participants who subsequently receive only segmentectomy or wedge resection;
Trial participants deemed surgically inoperable by the study center's surgical evaluation;
Undergoing major surgery within 4 weeks prior to the first dose, among others;
Trial design
Treatments tested in this trial
- BL-B01D1
- Osimertinib
- Carboplatin
- Pemetrexed
- Cisplatin
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator