NCT06704620

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

Safety and Effectiveness of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer: A Prospective, Randomized-controlled, Multi-center, Open-label, Phase-III Trial.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced and Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	Diphenhydramine	Diphenhydramine intramuscular injection 20mg qd d0-2 Q3W
DRUG	Tislelizumab	Tislelizumab intravenous infusion 200mg d1
DRUG	Pemetrexed	Pemetrexed intravenous infusion 500mg/m2 d1
DRUG	Albumin paclitaxel	Albumin paclitaxel intravenous infusion 260mg/m2 d1
DRUG	Carboplatin	Carboplatin intravenous infusion AUC5 d1
DRUG	Cisplatin	Cisplatin intravenous infusion 75mg/m2 d1

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2024-11-26
• Last updated: 2024-12-16

Locations

1 site across 1 country: China