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RECRUITING
NCT07632365
PHASE1/PHASE2

Induction Chemoimmunotherapy in Combination With Chemoradiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-Small Cell Lung Cancer

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

RADIATION

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.

DRUG

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