Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05948462
Status:
WITHDRAWN
Last Update Posted:
2023-12-13
First Post:
2023-06-27
Brief Title:
Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive ALK Non-small Cell Lung Cancer NSCLC Who Progressed on Single-agent Lorlatinib
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase II Study of Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive ALK Non-small Cell Lung Cancer NSCLC Who Progressed on Single-agent Lorlatinib
Status:
WITHDRAWN
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn by pharmaceutical funding partner
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NSCLC
Brief Summary:
This clinical trial is an open-label single arm study evaluating the safest dose of lorlatinib in combination with standard of care chemotherapy in participants with metastatic anaplastic lymphoma kinase positive ALK NSCLC who progressed on prior therapy of lorlatinib alone The main goals of this study are to
Evaluate the safety and tolerability of lorlatinib in combination with standard of care chemotherapy
Evaluate how well the combination of lorlatinib and standard of care chemotherapy works to treat metastatic anaplastic lymphoma kinase positive ALK NSCLC
Evaluate the pharmacokinetics PK of lorlatinib when given in combination with standard of care chemotherapy
Evaluate the safety and tolerability of lorlatinib in combination with standard of care chemotherapy
Evaluate how well the combination of lorlatinib and standard of care chemotherapy works to treat metastatic anaplastic lymphoma kinase positive ALK NSCLC
Evaluate the pharmacokinetics PK of lorlatinib when given in combination with standard of care chemotherapy
Detailed Description:
Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 This studys aim is to evaluate the safety of lorlatinib given in combination with platinum-based standard of care chemotherapy in participants with metastatic anaplastic lymphoma kinase positive ALK non-small-cell lung cancer who progressed after receiving lorlatinib alone
There will be a lead-in portion for the first six participants treated Lead-in participants will receive an assigned starting dose of lorlatinib by mouth once daily throughout each cycle In addition a platinum-based standard of care chemotherapy regimen to include carboplatin or cisplatin as well as pemetrexed will be given intravenously every 3 weeks A cycle is defined as 3 weeks After tolerability is confirmed in the lead-in with the first 6 participants on trial the next 9 participants may begin at an increased starting dose of lorlatinib by mouth once daily After 4 cycles of oral lorlatinib and intravenous platinum-based standard of care chemotherapy and intravenous pemetrexed the participant will move into the maintenance regimen The maintenance regimen will include continuing on daily oral lorlatinib plus intravenous pemetrexed every 3 weeks until disease progression or intolerable toxicity or other reason for discontinuation
There will be a lead-in portion for the first six participants treated Lead-in participants will receive an assigned starting dose of lorlatinib by mouth once daily throughout each cycle In addition a platinum-based standard of care chemotherapy regimen to include carboplatin or cisplatin as well as pemetrexed will be given intravenously every 3 weeks A cycle is defined as 3 weeks After tolerability is confirmed in the lead-in with the first 6 participants on trial the next 9 participants may begin at an increased starting dose of lorlatinib by mouth once daily After 4 cycles of oral lorlatinib and intravenous platinum-based standard of care chemotherapy and intravenous pemetrexed the participant will move into the maintenance regimen The maintenance regimen will include continuing on daily oral lorlatinib plus intravenous pemetrexed every 3 weeks until disease progression or intolerable toxicity or other reason for discontinuation
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