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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 ALCHEMIST_E4512 (Crizotinib)
Overall Recruitment Status: Active, currently enrolling
 
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 ALCHEMIST_E4512 (Crizotinib)
 
Region Sponsors
Mid-Atlantic
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
ALCHEMIST MA-18-182
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
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;
 
Purpose
The purpose of the ALCHEMIST E4512 (Crizotinib) research study is to evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB = 4cm, II and IIIA, ALK-positive NSCLC following surgical resection.
 
Detailed Description
The investigators hypothesize that personalized adjuvant therapy with crizotinib after surgical removal of part or all of a tissue, structure or organ will result in improved overall survival (OS) compared to placebo in patients with stage IB > 4cm, II and IIIA, Anaplastic Lymphoma Kinase (ALK) positive Non-Small Cell Lung Cancer (NSCLC).
 
Gender Age Limit
Male & Female
 
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
  • 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
 
Exclusion Criteria
  • 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
  • Please contact study personnel for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • ALCHEMIST
  • Lung Cancer
  • E4512 (Crizotinib)
  • Oncology (Adult)
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenberg, RN
-301-816-6768
-leslie.k.greenberg@kp.org
-Burke Medical Center


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