Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04127110
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2019-10-14
Brief Title:
Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Activity of Lorlatinib Based on ALK Resistance Mutations on Blood in ALK Positive NSCLC Patients Previously Treated With 2nd Generation ALK Inhibitor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
ALKALINE
Brief Summary:
This study includes patients diagnosed with a metastatic non small cell lung cancer NSCLC with anaplastic lymphoma kinase ALK translocation The standard treatment for patients with metastatic non small cell lung cancer with ALK translocation is represented by personalized treatment with drugs called ALK inhibitors During the treatment with an ALK inhibitor the tumour can start to grow again because the tumour adapts to the drug and develops escape mechanisms becoming resistant At the tumour cells level the mechanisms underlying resistance can include the development of other alterations mainly mutations including in the ALK gene The alterations that developed depend on the drug the tumour has been exposed to
The alterations can be identified by analysing tumour tissue obtained through a biopsy however repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test Therefore in the last years new tests have been developed to identify the mutations in the blood
Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors
The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib based on the alterations found in their genes
The alterations can be identified by analysing tumour tissue obtained through a biopsy however repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test Therefore in the last years new tests have been developed to identify the mutations in the blood
Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors
The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib based on the alterations found in their genes
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003862-41 | EUDRACT_NUMBER | None | None |