Last updated on February 2019

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)


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Clinical Study Identifier: NCT02201992

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Mount Vernon, OH United States
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Licking Memorial Hospital

Newark, OH United States
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Newark Radiation Oncology

Newark, OH United States
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Saint Charles Hospital

Oregon, OH United States
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Southern Ohio Medical Center

Portsmouth, OH United States
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North Coast Cancer Care

Sandusky, OH United States
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Flower Hospital

Sylvania, OH United States
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University of Toledo

Toledo, OH United States
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Mercy Saint Anne Hospital

Toledo, OH United States
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South Pointe Hospital

Warrensville Heights, OH United States
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University Pointe

West Chester, OH United States
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Saint Ann's Hospital

Westerville, OH United States
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Wright-Patterson Medical Center

Wright-Patterson Air Force Base, OH United States
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Mercy Hospital Oklahoma City

Oklahoma City, OK United States
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Bay Area Hospital

Coos Bay, OR United States
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Good Samaritan Hospital

Corvallis, OR United States
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Three Rivers Community Hospital

Grants Pass, OR United States
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Rogue Valley Medical Center

Medford, OR United States
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Kaiser Permanente Northwest

Portland, OR United States
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Bryn Mawr Hospital

Bryn Mawr, PA United States
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Geisinger Medical Center

Danville, PA United States
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Doylestown Hospital

Doylestown, PA United States
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Einstein Medical Center Montgomery

East Norriton, PA United States
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Easton Hospital

Easton, PA United States
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Ephrata Cancer Center

Ephrata, PA United States
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Ephrata Community Hospital

Ephrata, PA United States
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Adams Cancer Center

Gettysburg, PA United States
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Cherry Tree Cancer Center

Hanover, PA United States
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Jefferson Hospital

Jefferson Hills, PA United States
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Lewistown Hospital

Lewistown, PA United States
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Riddle Memorial Hospital

Media, PA United States
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Forbes Hospital

Monroeville, PA United States
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Allegheny Valley Hospital

Natrona Heights, PA United States
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Paoli Memorial Hospital

Paoli, PA United States
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Einstein Center One

Philadelphia, PA United States
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Allegheny General Hospital

Pittsburgh, PA United States
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UPMC-Magee Womens Hospital

Pittsburgh, PA United States
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UPMC-Presbyterian Hospital

Pittsburgh, PA United States
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UPMC-Saint Margaret

Pittsburgh, PA United States
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West Penn Hospital

Pittsburgh, PA United States
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UPMC-Shadyside Hospital

Pittsburgh, PA United States
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UPMC-Passavant Hospital

Pittsburgh, PA United States
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Community Medical Center

Scranton, PA United States
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Geisinger Medical Group

State College, PA United States
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Mount Nittany Medical Center

State College, PA United States
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Chester County Hospital

West Chester, PA United States
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UPMC Susquehanna

Williamsport, PA United States
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Lankenau Medical Center

Wynnewood, PA United States
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Newport Hospital

Newport, RI United States
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Rhode Island Hospital

Providence, RI United States
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Miriam Hospital

Providence, RI United States
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Roger Williams Medical Center

Providence, RI United States
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AnMed Health Cancer Center

Anderson, SC United States
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Gibbs Cancer Center-Gaffney

Gaffney, SC United States
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Saint Francis Hospital

Greenville, SC United States
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Greenville Memorial Hospital

Greenville, SC United States
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Saint Francis Cancer Center

Greenville, SC United States
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Self Regional Healthcare

Greenwood, SC United States
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South Carolina Cancer Specialists PC

Hilton Head Island, SC United States
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Spartanburg Medical Center

Spartanburg, SC United States
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Lexington Medical Center

West Columbia, SC United States
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Avera Cancer Institute

Sioux Falls, SD United States
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Memorial Hospital

Chattanooga, TN United States
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