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
Condition: Non Squamous Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: treatment; treatment
Intervention description: crizotinib 250mg orally continuous twice daily dosing; pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: open label; randomized Phase 3; first line treatment; non squamous lung cancer; ALK translocation event positive

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 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