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

Completed · Phase 3

Conditions studied: Non Squamous Lung Cancer

In brief

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

Key facts

Study ID

NCT01154140

Run by

Pfizer

People needed

343

Starts

2011-01-13

Expected to finish

2016-11-30

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• CCTAP — Fontana, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion — Loma Linda, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• CCTAP — Los Angeles, California, United States
• Kaiser Permanente Southern California — San Diego, California, United States
• CCTAP — San Diego, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Research Pharmacy, Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Lynn Cancer Institute Center for Hematology Oncology — Boca Raton, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Cancer Institute of Florida — Orlando, Florida, United States
• Investigational Drug Services — Orlando, Florida, United States
• Georgia Cancer Specialists — Athens, Georgia, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Decatur, Georgia, United States
• Georgia Cancer Specialists — Macon, Georgia, United States
• Georgia Cancer Specialists — Marietta, Georgia, United States
• Georgia Cancer Specialists — Sandy Springs, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Al Fisher, Pharm D. — Harvey, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Monroe Medical Associates — Harvey, Illinois, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.