Timing of Immunotherapy for Non-Small Cell Lung Cancer
Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer
Recruiting
Phase 3Interventional Study
Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
156 (estimated)
Sponsor
Hunan Province Tumor Hospital · Other
Who this trial is looking for
This trial is looking for adults with stage II-III lung cancer who can receive immunotherapy and chemotherapy before surgery. Participants will receive treatment either in the morning or afternoon and will be monitored for their response.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have resectable stage II to III non-small cell lung cancer.
I can receive immunotherapy and chemotherapy before surgery.
I have a good performance status.
I have not had any prior cancer treatment for my current lung cancer.
I have good bone marrow, liver, kidney, and heart function.
I can attend scheduled visits and follow treatment plans.
I have signed informed consent to participate.
You may not be able to join if
I have EGFR-sensitive mutations or ALK/ROS1 rearrangements.
I have uncontrolled brain metastases.
I have had another type of cancer in the last 3 years, except for certain skin cancers.
I have previously received therapy for lung cancer.
I have severe allergic reactions to PD-1 or PD-L1 inhibitors.
I have an active autoimmune disease needing strong treatment.
I have current infections like active HBV, HCV, or HIV.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 infusi…
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.
Trial Locations
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Eligibility 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 co…
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.
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