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) (NCT02201992)

🧪 Interventions in This Study

• Crizotinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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
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 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:
6. 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
7. Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
8. Women must not be pregnant or breast-feeding
9. 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)
10. Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception
11. 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
12. No known interstitial fibrosis or interstitial lung disease

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1618 Sites)

Showing the first 25 of 1618 sites.

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Southern Cancer Center PC-Daphne — Daphne, Alabama
• Southern Cancer Center PC-Mobile — Mobile, Alabama
• Southern Cancer Center PC-Providence — Mobile, Alabama
• Southern Cancer Center PC-Springhill — Mobile, Alabama
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Regional Hospital — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Fairbanks Memorial Hospital — Fairbanks, Alaska
• Banner MD Anderson Cancer Center — Gilbert, Arizona
• Kingman Regional Medical Center — Kingman, Arizona
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• Banner-University Medical Center Phoenix — Phoenix, Arizona
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona
• Mayo Clinic in Arizona — Scottsdale, Arizona
• Banner Boswell Medical Center — Sun City, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• Mercy Hospital Fort Smith — Fort Smith, Arkansas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.