Condition: Non-Small Cell Lung Cancer · Locally Advanced Non-Small Cell Lung Cancer · Unresectable Stage III NSCLC · Sponsor: Shanghai Chest Hospital
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.
This description comes directly from the study's public registry record.
Wen Yu, MD · 021-22200000-3203 · yuzhiwen0827@163.com
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| Shanghai Chest Hospital | Shanghai, Xuhui, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07632365