A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC
Trial Parameters
Brief Summary
This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. No gender restrictions; 3. Age at the time of signing the informed consent form ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Patients with locally advanced or metastatic non-squamous non-small cell lung cancer; 6. Confirmed known HER2 overexpression; 7. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years; 8. Must have at least one measurable lesion meeting the RECIST v1.1 criteria; 9. ECOG performance status score of 0 or 1; 10. Toxicities from prior anti-tumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; 11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 12. Organ function levels must meet the requirements; 13. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnanc