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Clinical Trials in Israel / NCT02201992
Active, not recruiting Phase 3

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)

NCT02201992 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2015-03-23
Last updated
2025-12-19

Condition(s) studied

ALK Gene RearrangementALK Gene TranslocationALK PositiveStage IB Non-Small Cell Lung Carcinoma AJCC v7Stage II Non-Small Cell Lung Cancer AJCC v7Stage IIA Non-Small Cell Lung Carcinoma AJCC v7Stage IIB Non-Small Cell Lung Carcinoma AJCC v7Stage IIIA Non-Small Cell Lung Cancer AJCC v7

Investigational drug(s) / intervention(s)

Clinical ObservationCrizotinib →Laboratory Biomarker Analysis

Clinical Observation: Undergo observation

Crizotinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Study summary

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)

Trial sites (1618)

FacilityCityRegionStatus
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 Israel

Official registry record

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.

View NCT02201992 on ClinicalTrials.gov ↗ ← All trials in Israel