Does Time of Day for Immunotherapy Matter Before Lung Cancer Surgery?
Compares morning and afternoon immunotherapy infusions before surgery in adults with non-small cell lung cancer.
Key facts
- Who runs it
- Hunan Province Tumor Hospital
- Where
- Changsha, ChinaSee the 2 sites
- Trial code
- Registry title
- Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 186 people, planned
- Started
- 12 Aug 2026
- Expected to end
- 31 May 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy
- Record updated
- 13 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage II-III non-small cell lung cancer that can be removed by surgery and who have not yet had cancer drug treatment. It tests whether morning or afternoon infusion of immunotherapy works better.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer, stage II to III, confirmed by tissue or cell tests and removable by surgery.
- Earlier treatment
- No earlier drug treatment (immunotherapy, chemotherapy or targeted therapy) for this lung cancer.
- Biomarker or test result
- People with EGFR-sensitive mutations or ALK/ROS1 rearrangements cannot join.
Main reasons for not taking part
- EGFR-sensitive mutation or ALK/ROS1 rearrangement
- Brain metastases that are uncontrolled or cause symptoms
- Another cancer within the last 3 years (a few treated skin or cervical cancers are allowed)
- Active autoimmune disease needing drugs that suppress the immune system
- Active HBV, HCV or HIV infection, or pregnancy or breastfeeding
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Presence of EGFR-sensitive mutations (e.g., exon 19del, L858R) or ALK/ROS1 rearrangements
- Participants meeting any of the following criteria will be excluded:
- Presence of uncontrolled or symptomatic brain metastases
- Pregnant or breastfeeding women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Hunan Cancer HospitalChangsha, ChinaContact: Yongchang Zhang, MDTaking people
- Hunna Cancer Hospital, Clinical Trails CenterChangsha, ChinaContact: Yongchang Zhang, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Morning infusion groupTreatment being tested
• Intervention / treatment: * Immune checkpoint inhibitor (one of approved PD 1 agents per investigator choice; e.g., toripalimab / pembrolizumab) administered in the morning window (08:00-11:00) for all ICI infusions during neoadjuvant treatment. * Combined with platinum based chemotherapy per institutional standard (examples: nab paclitaxel 260 mg/m² IV Day 1 Q3W + carboplatin AUC 5 IV Day 1 Q3W; or paclitaxel/cisplatin regimens per local practice). * Neoadjuvant treatment cycles: 4 cycles as per treating physician and local guideline; surgery scheduled after assessment. * Supportive care per routine practice.
Treatment: Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy
- Afternoon infusion groupExisting treatment, for comparison
• Intervention / treatment: * Same systemic regimen as Arm 1, but all ICI infusions administered in the afternoon window (15:00-18:00). * Chemotherapy, number of cycles (4), and surgical decision follow the same rules as Arm 1. * Supportive care per routine practice.
Treatment: Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Does Time of Day for Immunotherapy Matter Before Lung Cancer Surgery?Generated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07251582, who can take part
- Record updated
- 13 August 2026