Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01639001
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2012-07-10
Brief Title:
A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
PHASE 3 RANDOMIZED OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXEDCISPLATIN OR PEMETREXEDCARBOPLATIN IN PREVIOUSLY UNTREATED EAST ASIAN PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE ALK GENE LOCUS
Status:
COMPLETED
Status Verified Date:
2020-11
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 is a Phase III Randomized Open-label Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens PemetrexedCisplatin or PemetrexedCarboplatin in First-Line ALK Anaplastic Lymphoma Kinase Positive East Asian Non-Small Cell Lung Cancer Patients The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexedcisplatin or pemetrexedcarboplatin in prolonging Progression Free Survival PFS in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK Anaplastic Lymphoma Kinase gene locus
Detailed Description:
None
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