Exploratory Study of Adibelimab Combined With Famitinib and Chemotherapy for the Treatment of Patients With Driver Gene-Negative Locally Advanced or Metastatic NSCLC Progressing After PD-1 Monoclonal Antibody Combined With Chemotherapy

MA-NSCLC-#-037

This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance.

2024-03-30

2024-07-31

2026-12-31

Not yet recruiting

Early phase I

40

Inclusion Criteria: * Participants must be adults (≥18 years) who have signed an informed consent form. * They should have an ECOG performance status of 0-1. Diagnosed with stage IIIB-IV NSCLC and have progressed after PD-1 inhibitor treatment. * Expected to live at least 3 months and have at least one measurable lesion per RECIST v1.1. * Laboratory test results must meet specific criteria for blood counts, liver and kidney function, and coagulation parameters. * Patients with stable, treated brain metastases are eligible. * Women of childbearing potential and men with partners of childbearing potential must agree to use contraception. Exclusion Criteria: * Prior therapy with anti-PD-L1, anti-PD-L2, other immune checkpoint inhibitors, or specific cancer treatments. * Certain cancer types, known mutations, or recent use of systemic corticosteroids or immunosuppressive medications. * Active brain or leptomeningeal metastases without stability post-treatment, recent severe infections, or major surgery. * Other conditions that might interfere with the study, such as uncontrollable third-space fluid accumulations, active autoimmune diseases or infections, significant bleeding or thromboembolic events, serious heart conditions, severe allergies to study drugs, other active malignancies, HIV/AIDS, hepatitis B or C infection, or participation in another interventional clinical study within a specified period.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-03-29