Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456138
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Brief Title:
Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC
Sponsor:
Shanghai Chest Hospital
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant Advanced Non-small Cell Lung Cancer Patients a Multi-center Open-label Phase 12 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Lung cancer is the most common cause of cancer-related death worldwide Approximately 85 to 90 of lung cancer cases are non-small cell lung cancer NSCLC of which KRAS is one of the most common driver genes occurring in 25-30 of lung adenocarcinomas and 3-5 of squamous cell carcinomas KRAS-mutant NSCLC had been considered undruggable in past decades This research sought to address a significant challenge in treating NSCLC with KRAS mutations which are notoriously difficult to target effectively Here we proposal that the combined use of anlotinib and trametinib combined with tislelizumab may form an effective strategy for the treatment of KRAS-mutant NSCLC patients
Detailed Description:
This is a phase 12 open-label multi-center study aimed at exploring the potential therapeutic efficacy of tislelizumab intravenous trametinib oral and anlotinib oral in KRAS-mutant advanced non-small cell lung cancer patients The primary objectives were safety recommended phase 2 dose RP2D in Phase I and PFS in Phase II The secondary aim of the study is to evaluate the progression-free survival PFS overall survival OS adverse events AEs and duration of response DOR of the combined strategy in these patients If the RP2D is reached in Phase I Phase II will be started if RP2D is not reached in Phase I Phase II will not be started The number of subjects is determined according to the actual situation of dose climbing All patients will be of histo- andor cytopathology confirmed Determination of the KRAS mutation type will be performed in the pathological department of Shanghai Chest Hospital Shanghai Jiao Tong University School of Medicine Both ARMS method or targeted sequencing are acceptable It is not acceptable for subjects with the presence of other driver gene mutation All eligible subjects must have adequate renal hepatic and hematologic function as defined in inclusion criteria
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?:
None
Is an FDA AA801 Violation?:
None