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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)

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02201992
Protocol IDs
E4512 (primary)
NCI-2014-01507
U10CA180820
U10CA021115
Study Sponsor
ECOG-ACRIN Cancer Research Group

Summary

This phase III ALCHEMIST 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.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate whether adjuvant therapy with crizotinib will result in improved disease-free survival (DFS) for patients with stage IB >= 4cm, II and IIIA, ALK-positive non-small cell lung cancer (NSCLC) following surgical resection.

SECONDARY OBJECTIVES:
I. To evaluate and compare overall survival (OS) 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. Cycles repeat 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.

Eligibility

  1. Patients must have undergone complete surgical resection of their stage IIA, IIB, IIIA or IIIB non-squamous or squamous b NSCLC per American Joint Committee on Cancer (AJCC) 8th edition and have had negative margins. N3 disease is not allowed.
  2. 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
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  4. Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
  5. Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in EML4-ALK fusion) as defined by a Clinical Laboratory Improvement Act (CLIA)-approved test including: (1) translocation or inversion events involving the ALK gene locus (e.g. resulting in EML4-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay; (2) ALK protein expression by immunohistochemistry (IHC); or (3) ALK rearrangement identified by next generation (NextGen) sequencing; this must have been performed: * By a local 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)
  6. 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)
  7. Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
  8. No known interstitial fibrosis or interstitial lung disease
  9. No prior treatment with crizotinib or another ALK inhibitor
  10. 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
  11. 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
  12. Patients must be adequately recovered from surgery at the time of randomization
  13. The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
  14. 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
  15. 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
  16. Patients must have adequate organ function as defined by the following criteria within 2 weeks prior to randomization: * NOTE: it is strongly encouraged that these tests take place no more than one week prior to randomization to meet the 2 week requirement for randomization
  17. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  18. Total serum bilirubin =< 1.5 x ULN
  19. Absolute neutrophil count (ANC) >= 1500/mm^3
  20. Platelets >= 30,000/mm^3
  21. Hemoglobin >= 8.0 g/dL
  22. Serum creatinine =< 2 x ULN
  23. 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
  24. Patients may not be receiving any other investigational agents while on study

Treatment Sites in Georgia

Atlanta Cancer Care - Conyers


1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Doctors:

Richard A. Carter MD

Atlanta Cancer Care - Decatur


2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge


7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Atrium Health Navicent


Oncology Research, Atrium Health Navicent
777 Hemlock Street, MSC 123
(PACC 800 1st St, Ste 250)
Macon, GA 31201
4786332152
www.Atriumhealth.org

Study Coordinator:
Oncology Research Nurse
(478) 633-2152

Doctors:

Linda K. Hendricks MD
Bradley T. Sumrall MD
Harry F. Moore, Jr. MD

Cancer Center at DeKalb Medical Center


2675 North Decatur Road
Suite 410
Decatur, GA 30033
404-501-7789
www.dekalbmedical.org

Doctors:

Jayanthi Srinivasiah MD

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Georgia Cancer Specialists - CenterPointe


1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Macon-Coliseum


308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD

Northeast Georgia Medical Center - Gainesville


NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

Study Coordinator:
Trena Davis BSN, RN, CRCC
770-219-8822

Doctors:

Andre M. Kallab MD
Richard J. LoCicero MD
Padma C. Nadella MD
Charles H. Nash, III MD, FACP
Saloni H. Tanna MD
Christina A. Saurel MD

Piedmont Columbus Regional


1831 5th Ave
Columbus, GA 31901
www.columbusregional.com

Study Coordinator:
Jay Pitts, BS, CPhT
706-596-5426

Doctors:

Wilbur B. Bassett, Jr. MD
Andrew W. Pippas MD
Peter Q. Jiang MD
Suresh Nukala MD

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.