Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients must have undergone complete surgical resection of their stage IB (\>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed
* Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
* Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 \[EML4\]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5? and 3? ALK probes or the loss of the 5? probe; this must have been performed:
* By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR
* Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
* Women must not be pregnant or breast-feeding
* All females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* No known interstitial fibrosis or interstitial lung disease
* No prior treatment with crizotinib or another ALK inhibitor
* No ongoing cardiac dysrhythmias of grade \>= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval \> 470 msec
* No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined
* Patients must be adequately recovered from surgery at the time of randomization
* The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
* The maximum time requirement between surgery and randomization must be:
* 3 months (90 days) if no adjuvant chemotherapy was administered
* 8 months (240 days) if adjuvant chemotherapy was administered
* 10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered
* Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization
* NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study
* NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted
* Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
* Total serum bilirubin =\< 1.5 x ULN
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelets \>= 30,000/mm\^3
* Hemoglobin \>= 8.0 g/dL
* Serum creatinine =\< 2 x ULN
* Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =\< 1 with the exception of alopecia and the criteria outlined
* Patients must not have any history of locally advanced or metastatic cancer requiring systemic therapy within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer; patients must have no previous primary lung cancer diagnosed concurrently or within the past 2 years
* Patients may not be receiving any other investigational agents while on study
Primary outcome measure(s)
Overall survival (OS) — The time from randomization to death from any cause, assessed up to 10 years Distribution will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparison will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 5%. Other comparisons of groups will be made using the logrank test and Cox modeling. Estimate will be accompanied by the corresponding 90% confidence intervals.
Trial sites (1618)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Southern Cancer Center PC-Daphne
Daphne
Alabama
Southern Cancer Center PC-Mobile
Mobile
Alabama
Southern Cancer Center PC-Providence
Mobile
Alabama
Southern Cancer Center PC-Springhill
Mobile
Alabama
Anchorage Associates in Radiation Medicine
Anchorage
Alaska
Anchorage Radiation Therapy Center
Anchorage
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska
Alaska Oncology and Hematology LLC
Anchorage
Alaska
Alaska Regional Hospital
Anchorage
Alaska
Alaska Women's Cancer Care
Anchorage
Alaska
Anchorage Oncology Centre
Anchorage
Alaska
Katmai Oncology Group
Anchorage
Alaska
Providence Alaska Medical Center
Anchorage
Alaska
Fairbanks Memorial Hospital
Fairbanks
Alaska
Banner MD Anderson Cancer Center
Gilbert
Arizona
Kingman Regional Medical Center
Kingman
Arizona
Cancer Center at Saint Joseph's
Phoenix
Arizona
Banner-University Medical Center Phoenix
Phoenix
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Arizona
Mayo Clinic in Arizona
Scottsdale
Arizona
Banner Boswell Medical Center
Sun City
Arizona
Banner University Medical Center - Tucson
Tucson
Arizona
University of Arizona Cancer Center-North Campus
Tucson
Arizona
Mercy Hospital Fort Smith
Fort Smith
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
John L McClellan Memorial Veterans Hospital
Little Rock
Arkansas
Kaiser Permanente-Anaheim
Anaheim
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
California
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande
California
PCR Oncology
Arroyo Grande
California
Sutter Auburn Faith Hospital
Auburn
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
California
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
California
Kaiser Permanente-Baldwin Park
Baldwin Park
California
Kaiser Permanente-Bellflower
Bellflower
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
California
Mills-Peninsula Medical Center
Burlingame
California
+ 1578 more sites — see the full list on the official registry below.
More ECOG-ACRIN Cancer Research Group trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.