Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378892
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-10
Brief Title:
A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer NSCLC With Exclusively Extracranial Disease Progression on Lorlatinib
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
Centro di Riferimento Oncologico - Aviano
Study Overview
Official Title:
A Multicenter Single-arm Phase II Interventional Study to Evaluate the Activity and Safety of the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer NSCLC With Exclusively Extracranial Disease Progression on Lorlatinib
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ALK-PPL
Brief Summary:
This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer NSCLC with exclusively extracranial disease progression on Lorlatinib Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles Subsequently patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression unacceptable toxicity death or withdrawal of consent
Detailed Description:
This is a multicentre phase II interventional prospective single arm non-randomised study focused on ALK NSCLC with extracranial progression on LorlatinibTreatment phase include the period starting from cycle 1 day 1 visit to discontinuation of study therapy and consists of two phases induction phase and maintenance phase Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles Subsequently patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression unacceptable toxicity death or withdrawal of consent
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