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 (PROFILE 1014)
- Conditions
- Health Condition 1: null- Non Squamous Lung Cancer
- Registration Number
- CTRI/2012/01/002323
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 334
1.Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
2.Positive for translocation or inversion events involving the ALK gene locus
3.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
4.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.
1.Current treatment on another therapeutic clinical trial.
2.Prior therapy directly targeting ALK.
3.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.
4.Ongoing cardiac dysrhythmias of NCI CTCAE Grade greater than equal to 2, uncontrolled atrial fibrillation of any grade, or QTc interval greater than 470 msec.
5.Pregnancy or breastfeeding.
6.Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
7.Known HIV infection
8.Known interstitial lung disease or interstitial fibrosis
9.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Progression Free Survival [PFS] based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory)Timepoint: 35 months
- Secondary Outcome Measures
Name Time Method 1.Objective Response Rate [ORR ] documented by independent radiology laboratory, and Duration of Response [DR]Timepoint: 35 months;2.Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalitiesTimepoint: 35 months;3.Plasma concentrations of crizotinib (including its active moieties, if appropriate)Timepoint: 35 months;4.Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusionTimepoint: 35 months;5.Patient reported outcome measures of pain, dyspnea, or cough, disease/treatment-related symptoms, and general health status and Health Care Resource Utilization [HCRU]Timepoint: 35 months;6.Overall Survival [OS] at 6 months 12 months and overallTimepoint: 35 months