A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
NCT01639001
ABOUT THIS STUDY
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- Histologically or cytologically 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 for at least 2 weeks and are not taking any medications contraindicated in Exclusion Criteria
- 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.
- 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 CYP3A inducers/inhibitors Concurrent use
of drugs that are CYP3A substrates with narrow therapeutic indices.
- Known HIV infection
- History of extensive disseminated/bilateral or known presence of Grade 3 or 4
interstitial fibrosis or interstitial lung disease, including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior
radiation pneumonitis.
- Other severe acute or chronic medical conditions (including severe gastrointestinal
conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal
disease on hemodialysis, 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients | ||||||
Official Title ICMJE | PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF CRIZOTINIB VERSUS PEMETREXED/CISPLATIN OR PEMETREXED/CARBOPLATIN IN PREVIOUSLY UNTREATED EAST ASIAN PATIENTS WITH NON-SQUAMOUS CARCINOMA OF THE LUNG HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS | ||||||
Brief Summary | This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer Patients. The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma Kinase) gene locus. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | NSCLC (Non-small Cell Lung Cancer) | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Wu YL, Lu S, Lu Y, Zhou J, Shi YK, Sriuranpong V, Ho JCM, Ong CK, Tsai CM, Chung CH, Wilner KD, Tang Y, Masters ET, Selaru P, Mok TS. Results of PROFILE 1029, a Phase III Comparison of First-Line Crizotinib versus Chemotherapy in East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Oct;13(10):1539-1548. doi: 10.1016/j.jtho.2018.06.012. Epub 2018 Aug 14. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 207 | ||||||
Original Estimated Enrollment ICMJE | 200 | ||||||
Actual Study Completion Date ICMJE | January 8, 2020 | ||||||
Actual Primary Completion Date | June 30, 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | China, Hong Kong, Malaysia, Taiwan, Thailand | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01639001 | ||||||
Other Study ID Numbers ICMJE | A8081029 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |