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
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
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
Inclusion Criteria:
Exclusion Criteria:
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.
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.
Boston, Massachusetts 02215, United States
CABA, C1019ABS, Argentina
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310009, China
Homburg - Saar, 66421, Germany
Homburg - Saar, 66421, Germany
Regensburg, 93053, Germany
Sunto-gun, Shizuoka 411-8777, Japan
Chuo-Ku, Tokyo 104-0045, Japan
Distrito Federal, 14080, Mexico
Warsaw, 02-781, Poland
Omsk, Omsk Oblast 644013, Russia
Pesochniy Poselok, Sankt-Peterburg 197758, Russia
Seoul, 03722, South Korea
Las Palmas de Gran Canaria, Canary Islands 35016, Spain
Birmingham, WEST Midlands B9 5SS, United Kingdom