Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04292119
Status:
UNKNOWN
Last Update Posted:
2021-03-10
First Post:
2020-02-26
Brief Title:
Lorlatinib Combinations in Lung Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase IBII Study of Lorlatinib Combinations in Anaplastic Lymphoma Kinase-Rearranged Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
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:
This research study is evaluating Lorlatinib in combination with Crizotinib Binimetinib or TNO155 as a possible treatment for either anaplastic lymphoma kinase ALK-positive lung cancer or ROS1-positive lung cancer
This research study involves four study drugs
Lorlatinib
Binimetinib
Crizotinib
TNO155
This research study involves four study drugs
Lorlatinib
Binimetinib
Crizotinib
TNO155
Detailed Description:
This is a Phase III clinical trial of three investigational combinations for treatment of either anaplastic lymphoma kinase ALK-positive or ROS1-positive lung cancer The three drug combinations being tested are 1 Lorlatinib combined with Crizotinib and 2 Lorlatinib combined with Binimetinib and 3 Lorlatinib combined with TNO155
Lorlatinib is an oral ALK and ROS1 inhibitor The US Food and Drug Administration FDA has approved Lorlatinib for treatment of ALK-positive lung cancer The FDA has not approved Lorlatinib for treatment of ROS1-positive lung cancer
Crizotinib is an oral ALK and MET inhibitor The FDA has approved Crizotinib for treatment of ALK-positive lung cancer Crizotinib is not approved by the FDA for the treatment of MET-positive lung cancer This study will test crizotinibs ability to block MET signaling Crizotinib is not approved by the FDA for treatment of ROS1-positive lung cancer
Binimetinib is an oral MEK inhibitor The FDA has not approved binimetinib for treatment of ALK-positive or ROS1-positive lung cancer but it has been approved for other uses
TNO155 is an oral SHP2 inhibitor The FDA has not approved TNO155 for the treatment of any disease including ALK-positive or ROS1-positive lung cancer It is an investigational drug
The FDA has not approved the combination of Lorlatinib with Binimetinib Crizotinib or TNO155 as a treatment for any disease
The research study procedures include screening for eligibility and study treatment which will include evaluations and follow up visits
Patients will undergo screening and those who fulfill the eligibility criteria will be assigned to receive either the combination of Lorlatinib and Crizotinib the combination of Lorlatinib and Binimetinib or the combination of Lorlatinib and TNO155 Patients with ALK-positive or ROS1-positive lung cancer who have extra copies of the MET growth signal MET amplification will be assigned to receive the Lorlatinib and Crizotinib combination All other patients will be randomly assigned to receive one of the combinations
This study consists of 2 parts
Phase I
The investigators are looking to determine whether combining Lorlatinib with either Binimetinib Crizotinib or TNO155 is well tolerated and to understand how treatment with the two drugs affects cancer cells and impacts growth signals
Not everyone who participates in this research study will receive the same dose of the study drug The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated
Phase II
The Phase II study will test the safest doses of the combinations as established in the Phase I study in a larger group of patients
It is expected that about 96 people will take part in this research study
Lorlatinib is an oral ALK and ROS1 inhibitor The US Food and Drug Administration FDA has approved Lorlatinib for treatment of ALK-positive lung cancer The FDA has not approved Lorlatinib for treatment of ROS1-positive lung cancer
Crizotinib is an oral ALK and MET inhibitor The FDA has approved Crizotinib for treatment of ALK-positive lung cancer Crizotinib is not approved by the FDA for the treatment of MET-positive lung cancer This study will test crizotinibs ability to block MET signaling Crizotinib is not approved by the FDA for treatment of ROS1-positive lung cancer
Binimetinib is an oral MEK inhibitor The FDA has not approved binimetinib for treatment of ALK-positive or ROS1-positive lung cancer but it has been approved for other uses
TNO155 is an oral SHP2 inhibitor The FDA has not approved TNO155 for the treatment of any disease including ALK-positive or ROS1-positive lung cancer It is an investigational drug
The FDA has not approved the combination of Lorlatinib with Binimetinib Crizotinib or TNO155 as a treatment for any disease
The research study procedures include screening for eligibility and study treatment which will include evaluations and follow up visits
Patients will undergo screening and those who fulfill the eligibility criteria will be assigned to receive either the combination of Lorlatinib and Crizotinib the combination of Lorlatinib and Binimetinib or the combination of Lorlatinib and TNO155 Patients with ALK-positive or ROS1-positive lung cancer who have extra copies of the MET growth signal MET amplification will be assigned to receive the Lorlatinib and Crizotinib combination All other patients will be randomly assigned to receive one of the combinations
This study consists of 2 parts
Phase I
The investigators are looking to determine whether combining Lorlatinib with either Binimetinib Crizotinib or TNO155 is well tolerated and to understand how treatment with the two drugs affects cancer cells and impacts growth signals
Not everyone who participates in this research study will receive the same dose of the study drug The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated
Phase II
The Phase II study will test the safest doses of the combinations as established in the Phase I study in a larger group of patients
It is expected that about 96 people will take part in this research study
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?:
False
Is an FDA AA801 Violation?:
None