About this trial
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
Age ≥ 18 years and ≤ 75 years, regardless of gender;
Expected survival time ≥ 3 months;
Unresectable Stage III non-small cell lung cancer;
Disqualifiers
SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;
The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy;
Major surgery within 4 weeks prior to the first dose;
Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies/ADCs targeting EGFR and/or HER3;
Trial design
Treatments tested in this trial
- BL-B01D1
- Osimertinib
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator