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.
This study is a prospective, single-arm clinical investigation. It aims to assess the effectiveness of the Adibelimab monoclonal antibody in combination with Famitinib and chemotherapy for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) without driver mutations, who have progressed following initial treatment with PD-1 monoclonal antibodies and chemotherapy. The study's primary focus is on evaluating progression-free survival (PFS) among the 40 participants, spanning from December 2023 to December 2026. It intends to explore the therapeutic potential of switching from PD-1 to PD-L1 inhibitors in overcoming immune resistance and identify subgroups that may particularly benefit from this treatment strategy, thereby providing insights into personalized therapy for advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Adibelimab (1200mg, IV, every 3 weeks) combined with Famitinib (20mg, daily, orally) and Albumin-bound Paclitaxel (260mg/m2, Day 1, every 3 weeks)
Progression-free survival time (PFS)
the time from the start of the first dose of medication to the first occurrence of disease progression (as confirmed by the researcher according to RECIST v1.1 standards) or death from any cause, whichever occurs first.
Time frame: 4 months
Objective Response Rate
Objective Response Rate
Time frame: 4 months
Duration of Response
Duration of Response
Time frame: 4 months
Overall Survival
Overall Survival
Time frame: 4 months
Treatment-Related Adverse Events
Incidence rates of Treatment-Related Adverse Events, Serious Adverse Events and Treatment-Emergent Adverse Events
Time frame: 4 months
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