Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03456076
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2018-03-06
Brief Title:
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Open-Label Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB Tumors Equal to or Larger Than 4cm to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 active-controlled multicenter open-label Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting Participants in the experimental arm will receive alectinib at 600 mg orally twice daily BID taken with food for 24 months
Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles Following treatment completion participants will be followed up for their disease until disease recurrence At the time of disease recurrence participants will enter a survival follow-up until death withdrawal of consent or study closure whichever occurs earlier
Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles Following treatment completion participants will be followed up for their disease until disease recurrence At the time of disease recurrence participants will enter a survival follow-up until death withdrawal of consent or study closure whichever occurs earlier
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004331-37 | EUDRACT_NUMBER | None | None |