NCT07251582RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 12 Aug 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Hunan Province Tumor Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07251582
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 186
- From 12 Aug 2026 to the primary completion date, 31 Oct 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ.
- History of prior systemic therapy (immunotherapy, chemotherapy, or targeted therapy) for lung cancer.
Other illness
- Known severe allergic reactions to PD-1 or PD-L1 inhibitors (Grade ≥3 by CTCAE).
- Active autoimmune disease requiring systemic immunosuppression.
- Active infections, including active HBV, HCV, or HIV infection.
- Any comorbid condition or uncontrolled illness that, in the opinion of the investigator, may interfere with study participation or pose unacceptable risk.
Lab values
- Presence of EGFR-sensitive mutations (e.g., exon 19del, L858R) or ALK/ROS1 rearrangements.
Other
- Participants meeting any of the following criteria will be excluded:
- Presence of uncontrolled or symptomatic brain metastases.
- Pregnant or breastfeeding women.
Who the study is looking for
- Participants must meet all of the following criteria:
- Age ≥18 and ≤75 years at the time of enrollment.
- Histologically or cytologically confirmed diagnosis of resectable stage II to III non-small cell lung cancer (NSCLC).
- Deemed suitable for neoadjuvant immunotherapy combined with platinum-based chemotherapy and subsequent surgical resection based on multidisciplinary team (MDT) assessment.
- ECOG Performance Status of 0 or 1.
- No prior systemic antitumor therapy for the current NSCLC diagnosis.
- Adequate bone marrow, hepatic, renal, and cardiac function based on local laboratory standards.
- Willing and able to comply with scheduled visits, treatment plans, and other study procedures.
- Signed informed consent prior to participation.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Hunna Cancer Hospital, Clinical Trails Center Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.