CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled / 33 target
Drug / intervention
Crizotinibdrug
Likely dose
Crizotinib 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04084717
NCT04084717Phase 2CompletedOn Track (0.4/mo)Completion was 18mo ago
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Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)

University Health Network, Toronto·interventional·Posted Sep 10, 2019·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating Crizotinib for Non-squamous Non-small-cell Lung Cancer and 4 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This is a phase 2 study of a drug called crizotinib in people with metastatic (the cancer has spread to other parts of the body) non-small cell lung cancer with a mutation (change) in genes called ROS1 or MET. The purpose of this study is to look at how effective crizotinib is at treating ROS1 or MET mutated non-small cell lung cancer. Crizotinib, also called XALKORI, is a chemotherapy drug that is currently approved for the treatment of ALK- or ROS1- positive advanced non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-squamous Non-small-cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, ROS1 Gene Rearrangement, MET Activating Mutation, MET Amplification
CountriesCanada
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedSep 10, 2019
Enrollment StartDec 3, 2019
Primary CompletionDec 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 6.8 years ago

Arms & Interventions

ROS1 Rearrangementexperimental

Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement will be assigned to this arm.

Drug: Crizotinib
MET-activating Mutation (exon 14)experimental

Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-activating mutation (exon 14) will be assigned to this arm.

Drug: Crizotinib
MET-amplificationexperimental

Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-amplification will be assigned to this arm.

Drug: Crizotinib

Interventions

Crizotinibdrug

Crizotinib is an orally administered, chemotherapy drug that works by blocking ALK, MET and ROS1 receptor tyrosine kinases from working. Participants will receive crizotinib, orally (by mouth), at a dose of 250 mg, twice per day, every day of each 28 day cycle.