PIVOT study is a multicenter, phase I/II clinical study designed to evaluate induction chemoimmunotherapy followed by concurrent chemoradiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Phase I consists of a single-arm safety lead-in study evaluating the safety and preliminary efficacy of the investigational regimen. If predefined safety criteria are met, the study proceeds to a phase II randomized controlled trial comparing induction chemoimmunotherapy followed by concurrent chemoradiotherapy and consolidation immunotherapy with the standard PACIFIC regimen. The objective of the phase II study is to determine whether the investigational treatment strategy improves progression-free survival while maintaining an acceptable safety profile compared with the standard PACIFIC regimen.
Age >18 years, male or female, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Unresectable stage III NSCLC (according to the 8th edition of the AJCC staging system).
No prior exposure to any other anti-tumor therapy.
Presence of small cell carcinoma components in the histological examination results.
Co-occurrence of EGFR mutation, ALK rearrangement, or ROS-1 rearrangement positivity.
History of other primary malignancies, with the following exceptions: Malignancies treated with curative intent with no known active disease and low potential for recurrence for ≥5 years prior to the first dose of investigational product (IP); adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease.
Active or documented history of autoimmune or inflammatory diseases (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [excluding diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, granulomatosis with polyangiitis [Wegener's syndrome], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.).
Shanghai Chest Hospital
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
RenJi Hospital
Collaborator