A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant… (NCT07178795) | Clinical Trial Compass
RecruitingPhase 3
A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC
China440 participantsStarted 2025-09-29
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. HER2 functional mutation confirmed by a central laboratory;
✓. Provide the most recent tumor tissue meeting the requirements for biomarker testing by the central laboratory;
✓. Must have at least one measurable target lesion as defined by RECIST v1.1;
✓. ECOG performance status score of 0 or 1;
Exclusion criteria
✕. 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;