Status:
COMPLETED
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
Lead Sponsor:
Pfizer
Conditions:
Non Squamous Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.
Eligibility Criteria
Inclusion
- Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
- Positive for translocation or inversion events involving the ALK gene locus
- No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
- Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome \[PRO\] measures.
- 18 years of age or older with the exception of India which has an upper age limit of 65 years old
Exclusion
- Current treatment on another therapeutic clinical trial.
- Prior therapy directly targeting ALK.
- Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade \>=2, uncontrolled atrial fibrillation of any grade, or QTc interval \>470 msec.
- Pregnancy or breastfeeding.
- Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
- Known HIV infection
- Known interstitial lung disease or interstitial fibrosis
- Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
Key Trial Info
Start Date :
January 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT01154140
Start Date
January 13 2011
End Date
November 30 2016
Last Update
November 6 2017
Active Locations (249)
Enter a location and click search to find clinical trials sorted by distance.
1
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
2
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211-1850
3
CCTAP
Fontana, California, United States, 92335
4
Loma Linda University Cancer Center
Loma Linda, California, United States, 92350