Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer

This prospective study aims to investigate whether the time of day when immune checkpoint inhibitors (ICIs) are administered affects the efficacy of neoadjuvant immunotherapy in patients with resectable stage II-III non-small cell lung cancer (NSCLC). Eligible patients will receive standard-of-care neoadjuvant ICI plus platinum-based chemotherapy and be randomly assigned to either a morning infusion group (08:00-11:00) or an afternoon infusion group (15:00-18:00). The primary objective is to compare the pathological complete response (pCR) rates between groups. Secondary outcomes include major pathological response (MPR) and event-free survival (EFS). The study will include independent imaging and pathology review for endpoint assessment.

NCT Number	NCT07251582
Lead Sponsor	Hunan Province Tumor Hospital
Conditions	Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC)
Enrollment	186 participants
Start Date	2026-08-12
Primary Completion	2028-10-31 (estimated)
Study Completion	2029-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-13