Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03088930|
Recruitment Status : Withdrawn (Low Accrual)
First Posted : March 23, 2017
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer, Nonsmall Cell||Drug: Crizotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 13, 2017|
|Actual Primary Completion Date :||May 30, 2018|
|Estimated Study Completion Date :||October 2021|
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.
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
- The number of participants with an objective tumor response rate [ Time Frame: 6 weeks ]Participants' tumor response to treatment will be compared from initial/pretreatment scan to 6 week scan using RECIST 1.1
- The number of participants with pathologic response rate [ Time Frame: 5 years follow-up ]Pathologic response rate is defined as < 50% of viable tumor present histologically in the resected tumor specimen.
- The number of participants with metabolic response rate [ Time Frame: 6 weeks post treatment ]FDG-PET scan will measure metabolic pre-and post-induction therapy response as per PERCIST criteria
- The number of participants with disease-free survival (DFS) [ Time Frame: 5 years follow-up ]DFS is defined as the time from treatment to the first of either disease recurrence or death from any cause.
- The number of participants with overall survival (OS) [ Time Frame: 5 years follow-up ]OS is defined as the time from study enrollment to death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088930
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Robert Doebele, MD, PhD||University of Colorado, Denver|