Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT05394233
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2022-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC
Sponsor:
Sichuan Cancer Hospital and Research Institute
Organization:
Study Overview
Official Title:
Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed for Untreated EGFR+ and High PD-L1 Expression Non-squamous NSCLC :a Phase II, Single-center, Single Arm Study
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
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:
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study
Detailed Description:
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study;
Research purposes:
Main purpose: To evaluate the median progression-free rate of tislelizumab combined with bevacizumab and platinum pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression Survival (middle progression free survival, mPFS)
Secondary purpose:
* Evaluation of objective response rate (ORR) according to RECIST version 1.1;
* Evaluation of disease control rate (DCR) according to RECIST version 1.1;
* Assess overall survival (OS);
* Assess Duration of Response (DOR);
* Evaluate the safety of the treatment using NCI-CTCAE v5;
Exploratory Purpose:
• Assess potential predictive biomarkers.
Research purposes:
Main purpose: To evaluate the median progression-free rate of tislelizumab combined with bevacizumab and platinum pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression Survival (middle progression free survival, mPFS)
Secondary purpose:
* Evaluation of objective response rate (ORR) according to RECIST version 1.1;
* Evaluation of disease control rate (DCR) according to RECIST version 1.1;
* Assess overall survival (OS);
* Assess Duration of Response (DOR);
* Evaluate the safety of the treatment using NCI-CTCAE v5;
Exploratory Purpose:
• Assess potential predictive biomarkers.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: