A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
NCT03052608
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously irradiated. CNS metastases allowed if asymptomatic and not currently requiring corticosteroid treatment.
- Availability of an archival FFPE tissue specimen.
- No prior systemic NSCLC treatment.
- ECOG PS 0, 1, or 2.
- Age ≥18 years .
- Adequate Bone Marrow, Liver, Renal, Pancreatic Function
- Negative pregnancy test for females of childbearing potential
- Spinal cord compression unless good pain control attained
- Major surgery within 4 weeks prior to randomization.
- Radiation therapy within 2 weeks prior to randomization, including stereotactic or
partial brain irradiation. Whole brain irradiation within 4 weeks prior to
randomization
- Active bacterial, fungal, or viral infection
- Clinically significant cardiovascular disease, active or within 3 months prior to
enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,
bradycardia or congenital long QT syndrome
- Predisposing characteristics for acute pancreatitis in the last month prior to
randomization.
- History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial
fibrosis or interstitial lung disease
- Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical
cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate
cancer) within the last 3 years prior to randomization.
- Concurrent use of any of the following food or drugs within 12 days prior to the first
dose of lorlatinib or crizotinib.
1. known strong CYP3A inhibitors .
2. known strong CYP3A inducers
3. known P gp substrates with a narrow therapeutic index
- Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days
prior to the first dose of lorlatinib or crizotinib.
- Other severe acute or chronic medical or psychiatric condition, including recent or
active suicidal ideation or behavior, or laboratory abnormality that may increase the
risk associated with study participation or interfere with the interpretation of study
results
- Investigational site staff members directly involved in the conduct of the study and
their family members, or Pfizer employees, including their family members, directly
involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 2 weeks prior
to study entry and/or during study participation.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC | ||||||
Official Title ICMJE | A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER | ||||||
Brief Summary | A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population | ||||||
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 | Carcinoma, Non-Small-Cell Lung | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | Recruiting | ||||||
Estimated Enrollment ICMJE | 280 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | February 1, 2024 | ||||||
Actual Primary Completion Date | March 20, 2020 (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 and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Belgium, Canada, China, Czechia, France, Germany, Hong Kong, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States | ||||||
Removed Location Countries | Denmark | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03052608 | ||||||
Other Study ID Numbers ICMJE | B7461006 2016-003315-35 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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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 | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |