A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
Summary
This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) 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 pemetrexed/cisplatin or pemetrexed/carboplatin 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.
Timeline
- Start
- 2012-09-29
- Primary completion
- 2015-06-30
- Completion
- 2020-01-08
Outcome
Met primary endpoint
paper Crizotinib significantly prolonged PFS (hazard ratio, 0.402; 95% confidence interval [CI]: 0.286-0.565; p < 0.001). PMID 29966800 ↗
paper The median PFS was 11.1 months with crizotinib and 6.8 months with chemotherapy. PMID 29966800 ↗
release “met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC)” pfizer.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Crizotinib | Small molecule | 250 mg | Oral |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |