RecruitingPhase 3NCT07251582

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

A Prospective Study on the Effect of Infusion Timing of Immune Checkpoint Inhibitors on Pathologic Response in Patients With Resectable Stage II-III Non-Small Cell Lung Cancer Undergoing Neoadjuvant Therapy


Sponsor

Hunan Province Tumor Hospital

Enrollment

156 participants

Start Date

Dec 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether giving immunotherapy (a drug that activates the immune system) at a specific time during the day — morning vs. evening — affects how well it works against resectable (surgically removable) non-small cell lung cancer when given before surgery alongside chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed stage II or III non-small cell lung cancer that can be surgically removed - You have not yet received any treatment for your current lung cancer - You have been assessed by a multidisciplinary team as suitable for neoadjuvant (pre-surgery) immunotherapy and chemotherapy - Your general health (ECOG 0–1) and organ function meet study requirements **You may NOT be eligible if...** - Your tumor has EGFR mutations or ALK/ROS1 gene rearrangements (you would be directed to targeted therapy) - You have active brain metastases - You have had another cancer within the past 3 years - You have active autoimmune disease or are on immunosuppressants - You have active hepatitis B, C, or HIV - You are pregnant or breastfeeding - You have a known severe allergy to PD-1 or PD-L1 inhibitors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTime of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy

Patients will be randomly assigned (1:1) to receive all ICI infusions during either the morning window (08:00-11:00) or the afternoon window (15:00-18:00), throughout the neoadjuvant treatment period.


Locations(2)

Hunna Cancer Hospital, Clinical Trails Center

Changsha, Hunan, China

Hunan Cancer hospital

Changsha, Hunan, China

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NCT07251582