Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer

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

Trial Details

NCT ID
NCT07251582
Phase
PHASE3
Sponsor
Hunan Province Tumor Hospital
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Time of Day-based Assignment for Infusion of Immune Checkpoint Inhibitor (e.g., toripalimab, or pembrolizumab) + platinum-based chemotherapy
Locations (sample)
  • Changsha, Hunan, China|28.19874,112.97087
  • Changsha, Hunan, China|28.19874,112.97087

Key Eligibility Criteria

  • 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 multidisciplinar…

For full eligibility, visit ClinicalTrials.gov.

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