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Induction Chemoimmunotherapy in Combination With Chemoradiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-Small Cell Lung Cancer
Sponsor: Shanghai Chest Hospital
Summary
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.
Official title: A Phase I/II Multicenter Study Evaluating the Safety and Efficacy of Induction Chemoimmunotherapy Followed by Concurrent Chemoradiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2022-10-09
Completion Date
2028-12-31
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Induction chemoimmunotherapy
Phase I: Patients received platinum-based doublet chemotherapy plus a PD-L1 inhibitor every 3 weeks for 2-4 cycles. Phase II (experimental group): Patients received platinum-based doublet chemotherapy plus a PD-L1 inhibitor every 3 weeks for 2 cycles.
Concurrent chemoradiotherapy (cCRT)
Definitive thoracic radiotherapy delivered to the primary tumor and involved lymph nodes with concurrent platinum-based chemotherapy. Radiotherapy is administered at 50-60 Gy in 25-30 fractions using intensity-modulated radiotherapy techniques.
consolidation immunotherapy
PD-L1 inhibitor administered every 3 weeks after completion of radiotherapy for up to 1 year or until disease progression, unacceptable toxicity, or withdrawal of consent.
Locations (1)
Shanghai Chest Hospital
Shanghai, Xuhui, China