Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06704620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: