This trial is a registrational phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with first-line treatment of HER2-mutant advanced or metastatic non-squamous non-small cell lung cancer.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Age at the time of signing the informed consent form is ≥18 years and ≤75 years, regardless of gender;
Expected survival time ≥12 weeks;
Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer;
Having undergone surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose or within 5 half-lives;
Pathological findings indicating non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
Concurrent presence of other driver gene mutations for which targeted drug therapy is available and approved for NSCLC indications;
Previous treatment with HER2-targeted therapy or ADC drugs with camptothecin derivatives as the toxin;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator