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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

NCT01154140•Pfizer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (249)

Tower Cancer Research Foundation

Beverly Hills, California, United States

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

Key Dates

Start Date

January 13, 2011

Primary Completion Date

November 30, 2013

Completion Date

November 30, 2016

Last Updated

November 6, 2017

Enrollment

343

ACTUAL participants

Conditions

Non Squamous Lung Cancer

Interventions

treatment

DRUG

treatment

DRUG