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Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist(Diphenhydramine)in Advanced and Metastatic Non-Small Cell Lung Cancer

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Oct 2026 to Nov 2026
    • Study completion date: Oct 2027 to Nov 2027
    • Start date: Nov 2024 to Dec 2024
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if diphenhydramine can improve the effectiveness and decrease the toxicity for the treatment of advanced and metastatic Non-small cell lung cancer (NSCLC) with PD1 inhibitor plus chemotherapy. The main questions it aims to answer are: * Dose diphenhydramine improve the effectiveness and survival of advanced and metastatic NSCLC treated with PD1 inhibitor and chemotherapy? * Dose diphenhydramine decrease the toxicity of PD1 inhibitor plus platinum-based chemotherapy? * Researchers will compare patients with or without diphenhydramine to see if diphenhydramine works to improve the effectiveness and decrease the toxicity. Participants will: * Take standard treatment (tislelizumab and platinum-based chemotherapy) with/without diphenhydramine(20mg qd d0-2)every cycle. * Visit the clinic once every six weeks for checkups and tests * Keep a diary of their symptoms and survival visit based on the protocol.
Trial Details
NCT Number NCT06704620
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions
(from sponsor)
Advanced and Metastatic NSCLC
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 430 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov