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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
University of Colorado Denver
Aurora, Colorado, United States
The Number of Participants With an Objective Tumor Response Rate
Participants' tumor response to treatment will be compared from initial/pretreatment scan to 6 week scan using RECIST 1.1
Time frame: 6 weeks
The Number of Participants With Pathologic Response Rate
Pathologic response rate is defined as \< 50% of viable tumor present histologically in the resected tumor specimen.
Time frame: 37 months
Number of Participants With an Objective Response Rate
Number of participants with response rate per RECIST 1.1
Time frame: 6 weeks post treatment
The Number of Participants With Disease-free Survival (DFS)
DFS is defined as the time from treatment to the first of either disease recurrence or death from any cause.
Time frame: 37 months
Overall Survival (OS) Measured in Months
OS is defined as the time from study enrollment to death from any cause.
Time frame: 37 months
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