A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC
Trial Parameters
Brief Summary
This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. ECOG performance score of 0-1. 3. Life expectancy ≥ 3 months. 4. Have at least one measurable tumor lesion per RECIST v1.1. 5. Subjects with histologically confirmed locally advanced or metastatic NSCLC. 6. Good level of organ function. 7. Provide archived or fresh tumor tissue for vendor test. Exclusion Criteria: 1. Subjects with active central nervous system metastases or meningeal metastases; 2. History of serious cardiovascular and cerebrovascular diseases; 3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; 4. Severe infection within 4 weeks prior to the first dose; 5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 6. Subjects with uncontrolled tumor-related pain; 7. Received \>30 Gy of non-thoracic radical radiation therapy within