Ignite Creation Date:
2024-05-06 @ 5:51 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05456256
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2022-07-06
Brief Title:
A Study of LP-300 with Carboplatin and Pemetrexed in Never Smokers with Advanced Lung Adenocarcinoma
Sponsor:
Lantern Pharma Inc
Organization:
Lantern Pharma Inc
Study Overview
Official Title:
Phase II Trial of LP-300 in Combination with Carboplatin and Pemetrexed in Never Smoker Patients with Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment with Tyrosine Kinase Inhibitors The HARMONIC Study
Status:
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:
HARMONIC
Brief Summary:
The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population The primary objectives of this study are to determine progression-free survival PFS and overall survival OS in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone This has been designed as a multicenter open label phase II trial with 90 patients to be enrolled in the United States
Detailed Description:
Patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors TKIs will be eligible for enrollment The trial will proceed in two stages In the safety lead-in stage 6 patients will be enrolled and treated with the LP-300 co-administered in combination with carboplatin and pemetrexed In the absence of any safety signals in these patients the second stage of the trial protocol will begin This second stage consists of randomizing patients in a 21 allocation ratio to one of two arms investigational arm of carboplatin pemetrexed and LP-300 or the standard of care arm of carboplatin and pemetrexed Treatment of both groups will be on Day 1 of a 21-day cycle A total of 4 to 6 treatment cycles are planned number of cycles determined by PI discretion with the possibility of patients going into a pemetrexed maintenance phase afterwards
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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