Ignite Creation Date:
2024-05-06 @ 3:06 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02201992
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2014-07-21
Brief Title:
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations An ALCHEMIST Treatment Trial
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer Crizotinib Versus Observation for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase ALK Fusion Protein
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase ALK Mutations or changes in ALK can make it very active and important for tumor cell growth and progression Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival OS for patients with stage IB 4 cm II and IIIA ALK-positive non-small cell lung cancer NSCLC following surgical resection
SECONDARY OBJECTIVES
I To evaluate and compare disease-free survival DFS associated with crizotinib
II To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting
III To collect tumor tissue and blood specimens for future research
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive crizotinib orally PO twice daily BID on days 1-21 Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity
ARM B Patients undergo observation
After completion of study treatment patients are followed up every 6 months if 4 or 5 years from study entry and every 12 months if 5-10 or 6-10 years from study entry
I To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival OS for patients with stage IB 4 cm II and IIIA ALK-positive non-small cell lung cancer NSCLC following surgical resection
SECONDARY OBJECTIVES
I To evaluate and compare disease-free survival DFS associated with crizotinib
II To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting
III To collect tumor tissue and blood specimens for future research
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive crizotinib orally PO twice daily BID on days 1-21 Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity
ARM B Patients undergo observation
After completion of study treatment patients are followed up every 6 months if 4 or 5 years from study entry and every 12 months if 5-10 or 6-10 years from study entry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-01507 | REGISTRY | None | None |
| s16-02072 | None | None | None |
| E4512 | OTHER | None | None |
| E4512 | OTHER | None | None |
| U10CA180820 | NIH | None | None |
| U10CA180830 | NIH | None | None |
| U10CA021115 | NIH | None | None |
| U24CA196172 | NIH | CTEP | httpsreporternihgovquickSearchU24CA196172 |