Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started

Description

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.

Official Title

A Randomized Phase III Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Observation for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Details

PRIMARY OBJECTIVES:

  1. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB >= 4 cm, II and IIIA, ALK-positive non-small cell lung cancer (NSCLC) following surgical resection.

SECONDARY OBJECTIVES:

  1. To evaluate and compare disease-free survival (DFS) associated with crizotinib.

II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.

III. To collect tumor tissue and blood specimens for future research.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation.

After completion of study treatment, patients are followed up every 6 months if < 4 or 5 years from study entry, and every 12 months if 5-10 or 6-10 years from study entry.

Keywords

ALK Gene Rearrangement ALK Gene Translocation ALK Positive Stage IB Non-Small Cell Lung Carcinoma AJCC v7 Stage II Non-Small Cell Lung Cancer AJCC v7 Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Crizotinib Clinical Observation Laboratory Biomarker Analysis

Eligibility

For people ages 18 years and up

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/mm3

  • Platelets >= 30,000/mm3

  • 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

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla, California, 92093, United States
  • Kaiser Permanente-San Diego Mission accepting new patients
    San Diego, California, 92108, United States
  • Kaiser Permanente-San Diego Zion accepting new patients
    San Diego, California, 92120, United States
  • Naval Medical Center -San Diego accepting new patients
    San Diego, California, 92134, United States
  • Kaiser Permanente-San Marcos accepting new patients
    San Marcos, California, 92069, United States
  • Kaiser Permanente-Irvine accepting new patients
    Irvine, California, 92618, United States
  • Saint Joseph Hospital - Orange accepting new patients
    Orange, California, 92868, United States
  • Kaiser Permanente-Anaheim accepting new patients
    Anaheim, California, 92807, United States
  • Kaiser Permanente-Riverside accepting new patients
    Riverside, California, 92505, United States
  • Eisenhower Medical Center accepting new patients
    Rancho Mirage, California, 92270, United States
  • Desert Regional Medical Center in progress, not accepting new patients
    Palm Springs, California, 92262, United States
  • Saint Jude Medical Center accepting new patients
    Fullerton, California, 92835, United States
  • Loma Linda University Medical Center accepting new patients
    Loma Linda, California, 92354, United States
  • Kaiser Permanente-Ontario accepting new patients
    Ontario, California, 91761, United States
  • Kaiser Permanente Hospital accepting new patients
    Fontana, California, 92335, United States
  • Kaiser Permanente-Bellflower accepting new patients
    Bellflower, California, 90706, United States
  • City of Hope Rancho Cucamonga accepting new patients
    Rancho Cucamonga, California, 91730, United States
  • Kaiser Permanente - Harbor City accepting new patients
    Harbor City, California, 90710, United States
  • Presbyterian Intercommunity Hospital accepting new patients
    Whittier, California, 90602, United States
  • Kaiser Permanente-Baldwin Park accepting new patients
    Baldwin Park, California, 91706, United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte, California, 91010, United States
  • Los Angeles County-USC Medical Center accepting new patients
    Los Angeles, California, 90033, United States
  • USC / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles, California, 90033, United States
  • City of Hope South Pasadena accepting new patients
    South Pasadena, California, 91030, United States
  • Keck Medical Center of USC Pasadena accepting new patients
    Pasadena, California, 91105, United States
  • Kaiser Permanente-Cadillac accepting new patients
    Los Angeles, California, 90034, United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles, California, 90027, United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center accepting new patients
    Burbank, California, 91505, United States
  • Kaiser Permanente - Panorama City accepting new patients
    Panorama City, California, 91402, United States
  • Kaiser Permanente accepting new patients
    Woodland Hills, California, 91367, United States
  • AIS Cancer Center at San Joaquin Community Hospital accepting new patients
    Bakersfield, California, 93301, United States
  • Hope Cancer Care of Nevada-Pahrump accepting new patients
    Pahrump, Nevada, 89048, United States
  • Cancer and Blood Specialists-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada - Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Las Vegas Cancer Center-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Nevada Cancer Specialists-Saint Rose accepting new patients
    Henderson, Nevada, 89052, United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin accepting new patients
    Las Vegas, Nevada, 89113, United States
  • Las Vegas Cancer Center-Medical Center accepting new patients
    Las Vegas, Nevada, 89148-2405, United States
  • 21st Century Oncology-Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Nevada Cancer Specialists-Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • 21st Century Oncology-Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • PCR Oncology accepting new patients
    Pismo Beach, California, 93449, United States
  • Radiation Oncology Centers of Nevada Southeast accepting new patients
    Las Vegas, Nevada, 89119, United States
  • Pacific Central Coast Health Center-San Luis Obispo accepting new patients
    San Luis Obispo, California, 93401, United States
  • Comprehensive Cancer Centers of Nevada-Summerlin accepting new patients
    Las Vegas, Nevada, 89144, United States
  • Summerlin Hospital Medical Center accepting new patients
    Las Vegas, Nevada, 89144, United States
  • Desert West Surgery accepting new patients
    Las Vegas, Nevada, 89102, United States
  • Nevada Cancer Specialists?Oakey accepting new patients
    Las Vegas, Nevada, 89102, United States
  • University Medical Center of Southern Nevada accepting new patients
    Las Vegas, Nevada, 89102, United States
  • 21st Century Oncology accepting new patients
    Las Vegas, Nevada, 89109, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Comprehensive Cancer Centers of Nevada - Central Valley accepting new patients
    Las Vegas, Nevada, 89169, United States
  • University Cancer Center accepting new patients
    Las Vegas, Nevada, 89169, United States
  • Cancer Therapy and Integrative Medicine accepting new patients
    Las Vegas, Nevada, 89121, United States
  • 21st Century Oncology-Vegas Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Ann M Wierman MD LTD accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada - Northwest accepting new patients
    Las Vegas, Nevada, 89128, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Nevada Cancer Specialists-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Shadow accepting new patients
    Las Vegas, Nevada, 89106, United States
  • Nevada Cancer Research Foundation CCOP accepting new patients
    Las Vegas, Nevada, 89106, United States
  • Radiation Oncology Centers of Nevada Central accepting new patients
    Las Vegas, Nevada, 89106, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills accepting new patients
    Las Vegas, Nevada, 89149, United States

Details

Status
accepting new patients
Start Date
Sponsor
ECOG-ACRIN Cancer Research Group
ID
NCT02201992
Phase
Phase 3
Lead Scientist
Lyudmila A. Bazhenova
Study Type
Interventional
Last Updated
December 7, 2017