A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SI-B001+SI-B003 With or Without Chemotherapy (SI-B001+SI-B003± Chemotherapy) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Phase Ib: To observe the safety and tolerability of the combination of SI-B001 and SI-B003, and to determine the recommended dose of phase II clinical study (RP2D) in the indication of locally advanced or metastatic non-small cell lung cancer. Phase II: To evaluate the efficacy of SI-B001+SI-B003 combination with or without chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer.
• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Subjects must agree to complete ctDNA testing during the screening period;
• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) patients;
• Agree to provide archived or fresh tumor tissue samples from primary or metastatic lesions;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Performance status score: ECOG ≤1;
⁃ Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
⁃ No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
⁃ Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug;
⁃ Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
⁃ Urine protein ≤1+ or ≤1000 mg/24h;
⁃ Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 24 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.