Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer
NCT03088930
ABOUT THIS STUDY
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1. Stage IA-IIIA NSCLC by 8th edition AJCC staging (that is deemed to be surgically resectable by a board certified thoracic surgeon.
2. Staging by PET-CT scan and MRI brain showing no evidence of metastatic disease (mediastinoscopy is not required unless imaging is indeterminate and is then considered standard of care)
3. Documented evidence of an ALK rearrangement (by FISH, IHC, or NGS), ROS1 rearrangement (by FISH or NGS), or MET oncogene as defined by MET exon 14 skipping (NGS), MET Y1003X mutation or MET gene fusion (NGS) in NSCLC tumor specimen by a CLIA-approved laboratory.
4. Measurable disease defined by RECIST 1.1 criteria.
5. Life expectancy of at least 24 months.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
7. Age ≥ 18 years
8. Have normal QT interval on ECG evaluation QT corrected Fridericia (QTcF) of ≤ 450 ms in males or ≤ 470 ms in females
9. Adequate organ function:
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥75,000/µL
- Hemoglobin ≥ 10g/dL
- AST /ALT ≤ 2.5 x upper limit of normal (ULN)
- Total serum bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x UNL
- Serum amylase/lipase ≤ 1.5 x UNL
10. Negative serum pregnancy test within 7 days of D1 of treatment in women of child bearing potential.
11. If fertile, willing to use highly effective form of contraception (defined as a combination of at least two of the following methods: condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during the dosing period and for at least 4 months after the dosing period.
12. Ability to provide signed informed consent and willing and able to comply with all study requirements.
1. Stage IIIB or IV NSCLC.
2. History or the presence of pulmonary interstitial disease, or drug-related
pneumonitis.
3. Malabsorption syndrome or other GI illness that could affect oral absorption of the
study drug
4. Inability to swallow oral medications
5. Have significant, uncontrolled or active cardiovascular disease, specifically
including but restricted to:
- Myocardial infarction (MI) within 6 months of trial enrollment
- Unstable angina within 6 months of trial enrollment
- Congestive heart failure (CHF) with 6 months prior to trial enrollment
- Any history of ventricular arrhythmia
- Cerebrovascular accident or transient ischemic attack within 6 months of D1 of
treatment
- Clinically significant atrial arrhythmia or severe baseline bradycardia defined
as resting heart rate < 50 beat per minute
- Uncontrolled hypertension defined as baseline SBP> 160 and DBP > 100 on 3
separate clinic visits or past history of hypertensive urgency, emergency or
encephalopathy
6. Have active infection requiring antibiotics
7. Pregnant or lactating female.
8. Prior treatment with an ALK, ROS1 or MET inhibitor
9. Any prior anticancer therapy for this diagnosis
10. Any active cancer diagnosis (basal or squamous cell cancers allowed) within the last 5
years for which the patient is receiving active therapy or which is untreated. Any
cancer diagnosis within the last 5 years that is considered "treated" and/ or on
surveillance may be included in the trial.
11. Have any condition or illness that, in the opinion of the investigator would
compromise patient safety or interfere with evaluation of the study drug (including
but not limited to HIV and HCV)
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Descriptive Information | |||||
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Brief Title ICMJE | Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer | ||||
Official Title ICMJE | A Phase II Trial to Evaluate Crizotinib in the Neoadjuvant Setting in Patients With Surgically Resectable, ALK, ROS1, or MET-oncogene Positive Non-small Cell Lung Cancer | ||||
Brief Summary | This study will evaluate the efficacy of crizotinib as induction therapy in participants with surgically resectable ALK rearrangement, ROS1 rearrangement, or MET exon 14 mutation positive NSCLC. | ||||
Detailed Description | Participants with stage IA-IIIA, surgically resectable lung adenocarcinoma with an activating alteration in ALK, ROS1 or MET will receive neoadjuvant treatment with crizotinib. This neoadjuvant treatment will last 6 weeks and on the last day of dosing of crizotinib, participants will undergo surgical resection, followed by 5 years of follow-up via chart review. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Lung Cancer, Nonsmall Cell | ||||
Intervention ICMJE | Drug: Crizotinib
Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary. Other Name: Xalkori | ||||
Study Arms ICMJE | Experimental: Neoadjuvant treatment with Crizotinib
Patients enrolled in this study will be treated with 6 weeks of induction therapy with crizotinib. On the last day of dosing, patients will then undergo surgical resection. 5 years of follow-up will be done via chart review. Intervention: Drug: Crizotinib | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE | 3 | ||||
Original Estimated Enrollment ICMJE | 18 | ||||
Estimated Study Completion Date ICMJE | January 31, 2022 | ||||
Estimated Primary Completion Date | January 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03088930 | ||||
Other Study ID Numbers ICMJE | 16-2025.cc | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Colorado, Denver | ||||
Study Sponsor ICMJE | University of Colorado, Denver | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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PRS Account | University of Colorado, Denver | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |