NCT07251582 Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer
| NCT ID | NCT07251582 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hunan Province Tumor Hospital |
| Condition | Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2026-08-12 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 186 participants in total. It began in 2026-08-12 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07251582 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07251582 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 186 participants.
Is NCT07251582 currently recruiting?
Yes, NCT07251582 is actively recruiting participants. Contact the research team at zhanglei1152@126.com for enrollment information.
Where is the NCT07251582 trial being conducted?
This trial is being conducted at Changsha, China, Changsha, China.
Who is sponsoring the NCT07251582 clinical trial?
NCT07251582 is sponsored by Hunan Province Tumor Hospital. The trial plans to enroll 186 participants.
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