Clinical Trial VICCTHO1079
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
- Protocol No. VICCTHO1079
- Open Date: 07/27/2011
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To demonstrate that crizotinib is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin, in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK gene locus.
- Disease Sites: Non Small Cell
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Alimta; Carboplatin; Cisplatin; Crizotinib; PF-02341066; Pemetrexed
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01154140
- Secondary Protocol No: A8081014
Patients are being asked to take part in this research study because they have been diagnosed with Non-Small Cell Lung cancer (NSCLC). The main purpose of this study is to see whether a new investigational drug, called crizotinib, can keep their cancer from growing for a longer period of time compared to the currently available chemotherapy agents- pemetrexed/carboplatin or pemetrexed/cisplatin. Other purposes of study are to see whether patients taking crizotinib live longer, have fewer side effects, experience a higher quality of life and also to measure how much crizotinib is in their blood. Because this is a research study, crizotinib will be given to patients only during the study and not after the study has finished. Crizotinib is considered an investigational drug because it is not approved by any country Health Authority such as the Food and Drug Administration (FDA) for use outside clinical trials. About 334 people will take part in this study worldwide. About 5 people will take part at Vanderbilt.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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
• 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