Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHunan Province Tumor Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of EGFR-sensitive mutations (e.g., exon 19del, L858R) or ALK/ROS1 rearrangements.
Presence of uncontrolled or symptomatic brain metastases.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy
Other interventionPatients will be randomly assigned (1:1) to receive all ICI infusions during either the morning window (08:00-11:00) or the afternoon window (15:00-18:00), throughout the neoadjuvant treatment period.
Treatment groups
186 Participants
are divided into 2 treatment groupsGroup A: Morning infusion groupExperimental treatment 1 intervention
Group B: Afternoon infusion groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pathological Complete Response (pCR) rate
Proportion of patients achieving pathological complete response (no viable tumor cells in resected primary tumor and sampled regional lymph nodes) assessed on surgical specimen after completion of neoadjuvant therapy and surgery.
Time frame
At the time of surgery, approximately 6-9 weeks after randomizationSecondary outcomes
1
Event Free Survival (EFS)
Time from randomization to disease progression that precludes surgery, recurrence, or death from any cause, whichever occurs first.
Time frame
From date of randomization to event occurrence (disease progression, recurrence, or death), assessed up to 36 months2
Major Pathological Response (MPR) rate
Proportion of patients with ≤10% viable tumor cells in the resected primary tumor specimen.
Time frame
At the time of surgery, approximately 6-9 weeks after randomizationSponsors and contacts
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Source ClinicalTrials.gov