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Using crizotinib to treat early-stage non-small cell lung cancer with ALK mutations after surgery

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

Phase 3 Interventional Eastern Cooperative Oncology Group · NCT02201992

This study is testing if the drug crizotinib can help people with early-stage non-small cell lung cancer that has ALK mutations live longer after their surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment168 (estimated)
Ages18 Years and up
SexAll
SponsorEastern Cooperative Oncology Group Research network
Drugs / interventionscrizotinib, chemotherapy, radiation, methotrexate
Locations1619 sites (Birmingham, Alabama and 1618 other locations)
Trial IDNCT02201992 on ClinicalTrials.gov

What this trial studies

This phase III trial investigates the effectiveness of crizotinib in improving overall survival for patients with stage IB-IIIA non-small cell lung cancer (NSCLC) that has been surgically removed and is positive for ALK fusion mutations. Patients are randomly assigned to receive crizotinib or undergo observation after surgery. The study aims to evaluate not only overall survival but also disease-free survival and the safety profile of crizotinib. Additionally, tumor tissue and blood samples will be collected for future research.

Who should consider this trial

Good fit: Ideal candidates are patients who have undergone complete surgical resection of stage IB (≥ 4 cm), II, or non-squamous IIIA NSCLC and are positive for ALK gene rearrangements.

Not a fit: Patients with non-ALK-positive lung cancer or those who have not had complete surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with ALK-positive non-small cell lung cancer after surgery.

How similar studies have performed: Other studies have shown promising results with crizotinib in treating ALK-positive lung cancer, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* 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:

  * 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
  * Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)
* 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
* Patients must be adequately recovered from surgery at the time of randomization
* The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
* 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
* 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
* 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

Where this trial is running

Birmingham, Alabama and 1618 other locations

+1569 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ALK Gene RearrangementALK Gene TranslocationALK PositiveStage IB Non-Small Cell Lung Carcinoma AJCC v7Stage II Non-Small Cell Lung Cancer AJCC v7Stage IIA Non-Small Cell Lung Carcinoma AJCC v7Stage IIB Non-Small Cell Lung Carcinoma AJCC v7Stage IIIA Non-Small Cell Lung Cancer AJCC v7
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.