Actively Recruiting
Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer
Led by Hunan Province Tumor Hospital · Updated on 2025-11-26
156
Participants Needed
2
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at enrollment
- Histologically or cytologically confirmed resectable stage II to III non-small cell lung cancer (NSCLC)
- Suitable for neoadjuvant immunotherapy with platinum-based chemotherapy and surgery as assessed by a multidisciplinary team
- ECOG Performance Status of 0 or 1
- No prior systemic treatment for current NSCLC
- Adequate bone marrow, liver, kidney, and heart function per local labs
- Willing and able to follow study visits, treatments, and procedures
- Signed informed consent before participation
You will not qualify if you...
- Presence of EGFR-sensitive mutations or ALK/ROS1 rearrangements
- Uncontrolled or symptomatic brain metastases
- History of other cancers within 3 years except treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ
- Prior systemic therapy for lung cancer including immunotherapy, chemotherapy, or targeted therapy
- Severe allergic reaction to PD-1 or PD-L1 inhibitors (Grade 3 or higher)
- Active autoimmune disease requiring systemic immunosuppression
- Active infections such as hepatitis B, hepatitis C, or HIV
- Pregnant or breastfeeding women
- Any uncontrolled illness or condition that may interfere with study participation or pose risk according to the investigator
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Trial Site Locations
Total: 2 locations
1
Hunna Cancer Hospital, Clinical Trails Center
Changsha, Hunan, China, 410013
Actively Recruiting
2
Hunan Cancer hospital
Changsha, Hunan, China
Actively Recruiting
Research Team
Y
Yongchang Zhang, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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