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)

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT02201992
Trial Phases:	Phase III	Protocol IDs:	E4512 (primary) NCI-2014-01507 U10CA180820 U10CA021115
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	ECOG-ACRIN Cancer Research Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT02201992

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.

Patients in both arms also undergo computed tomography (CT) throughout the trial. Patients may undergo blood and tissue sample collection on the trial.

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.

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta
3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005
770-777-1315
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD

Silpa C. Reddy MD

Sreekanth C. Reddy MD

Ronald G. Steis MD

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 - Cumming
1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041
www.atlantacancercare.com

Doctors:

Sreekanth C. Reddy MD

Ronald G. Steis MD

Amelia B. Zelnak MD

Kelly A. May 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

Atlanta Cancer Care - Tower
5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342
404-303-3355
www.atlantacancercare.com

Doctors:

Colleen S. Austin MD

Silpa C. Reddy MD

Sreekanth C. Reddy MD

Kelly A. May 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 - Athens
125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com

Doctors:

Ranjana S. Bhargava MD

Priya Rudolph

Georgia Cancer Specialists - Canton
228 Riverstone Drive
Canton, GA 30114
www.gacancer.com

Doctors:

Louis Crain Garrot MD

Gena H. Volas-Redd MD

Lynn M. Zemsky MD

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 - Kennestone
790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com

Doctors:

Louis Crain Garrot MD

Gena H. Volas-Redd MD

Lynn M. Zemsky 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

Georgia Cancer Specialists - Stemmer
2712 Lawrenceville Highway
Decatur, GA 30033
770-496-5555
www.gacancer.com

Doctors:

Jayanthi Srinivasiah MD

Simbo O. Aduloju MD

Aaron R. Alizadeh MD

Kathleen E. Lambert MD

Gwinnett Medical Center
1000 Medical Center Boulevard
Lawrenceville, GA 30046
404-851-2340
www.gwinnettmedicalcenter.org

Study Coordinator:

Qun Zeng
678-312-3829

Doctors:

Allan Freedman MD

Christopher T. Hagenstad MD

Aldemar Montero MD

Alexander F. Saker, Jr. MD

P. Ravi Sarma MD, FACP

Philip D. Shrake MD

Satvir Singh MD

Kevin H. Peacock MD

Mohan Krishnamachary MD

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

Doctors:

Mark A. Taylor MD

Grant C. Lewis MD

Ronald Goldberg MD

Alison Spellman MD

Gary W. Thomas MD

Majd Chahin 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

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Study Coordinator:

404-303-3355

Doctors:

Pradeep C. Jolly MD

Cheryl F. Jones MD

Jayanthi Srinivasiah MD

Gena H. Volas-Redd MD

Amelia B. Zelnak MD

Simbo O. Aduloju MD

Premila Malhotra MD

Aaron R. Alizadeh MD

Kelly A. May MD

Ranjana S. Bhargava MD

Priya Rudolph

Kathleen E. Lambert 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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.