About this trial
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.
Eligibility criteria
Qualifiers
Sign the informed consent form voluntarily and follow the protocol requirements;
Age ≥18 years old;
Expected survival time ≥3 months;
Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;
Disqualifiers
Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;
Patients with previous systemic therapy;
Patients had received EGFR-TKI therapy;
Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;
Trial design
Treatments tested in this trial
- BL-B01D1
- Osimertinib
- Osimertinib
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator