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Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 to 75

Infusion timing and pathologic response to neoadjuvant immunotherapy in resectable NSCLC

Official title: 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

Run by Hunan Province Tumor Hospital · NCT07251582 · Data updated 2026-11-12

This trial will test whether getting immunotherapy infusions in the morning versus the afternoon changes tumor response in people with resectable stage II–III non-small cell lung cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment186 (estimated)
SponsorHunan Province Tumor Hospital
Academic / other
Drugs / interventionschemotherapy, immunotherapy, toripalimab, pembrolizumab
Locations2 sites (Changsha, Hunan and 1 other locations)
StatusRecruiting
StartedAugust 12, 2026
Main results expectedOctober 31, 2028
Study endsMay 31, 2029
Registry record updatedAugust 13, 2026
Trial IDNCT07251582 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 with histologically confirmed resectable stage II–III NSCLC, ECOG 0–1, no prior systemic therapy, and who are candidates for neoadjuvant ICI plus platinum chemotherapy and surgery are eligible.

Probably not a fit

Patients with EGFR-sensitive mutations or ALK/ROS1 rearrangements, unresectable disease, prior systemic therapy for this diagnosis, or poor performance status are unlikely to be eligible or benefit from the timing comparison.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 study assigns patients with resectable stage II–III NSCLC to receive all immune checkpoint inhibitor infusions either in a morning window (08:00–11:00) or an afternoon window (15:00–18:00) alongside standard platinum-based neoadjuvant chemotherapy. The primary endpoint is pathological complete response (pCR) after surgery, with secondary endpoints including major pathological response (MPR) and event-free survival (EFS). Independent imaging and pathology review will be used for endpoint assessment. The trial is designed to provide prospective evidence on whether circadian timing of ICI administration affects neoadjuvant treatment efficacy.

Why it matters

Potential benefit: If morning versus afternoon infusion timing improves pathological response, patients could achieve higher pCR rates without changing drugs or increasing toxicity.

How similar studies have gone: Retrospective analyses in multiple cancer types have suggested better outcomes with morning ICI infusions, but prospective randomized evidence—especially in the neoadjuvant resectable NSCLC setting—is not yet available.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants must meet all of the following criteria:

1. Age ≥18 and ≤75 years at the time of enrollment.
2. Histologically or cytologically confirmed diagnosis of resectable stage II to III non-small cell lung cancer (NSCLC).
3. Deemed suitable for neoadjuvant immunotherapy combined with platinum-based chemotherapy and subsequent surgical resection based on multidisciplinary team (MDT) assessment.
4. ECOG Performance Status of 0 or 1.
5. No prior systemic antitumor therapy for the current NSCLC diagnosis.
6. Adequate bone marrow, hepatic, renal, and cardiac function based on local laboratory standards.
7. Willing and able to comply with scheduled visits, treatment plans, and other study procedures.
8. Signed informed consent prior to participation.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

1. Presence of EGFR-sensitive mutations (e.g., exon 19del, L858R) or ALK/ROS1 rearrangements.
2. Presence of uncontrolled or symptomatic brain metastases.
3. 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.
4. History of prior systemic therapy (immunotherapy, chemotherapy, or targeted therapy) for lung cancer.
5. Known severe allergic reactions to PD-1 or PD-L1 inhibitors (Grade ≥3 by CTCAE).
6. Active autoimmune disease requiring systemic immunosuppression.
7. Active infections, including active HBV, HCV, or HIV infection.
8. Pregnant or breastfeeding women.
9. Any comorbid condition or uncontrolled illness that, in the opinion of the investigator, may interfere with study participation or pose unacceptable risk.

Where it's running

  • Hunna Cancer Hospital, Clinical Trails Center
    Changsha, Hunan, China     Recruiting
  • Hunan Cancer hospital
    Changsha, Hunan, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.