Study of Crizotinib for ROS1 and MET Activated Lung Cancer

  • STATUS
    Recruiting
  • End date
    Jun 26, 2025
  • participants needed
    50
  • sponsor
    University Health Network, Toronto
Updated on 26 January 2021
cancer
measurable disease
ROS1
crizotinib
squamous non-small cell lung cancer

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.

Description

The study consists of a screening period, study drug period, end of study drug visit and follow-up period.

During the screening period, participants will be asked to have tests and procedures done to make sure that they are eligible to continue in the study. Screening may take several visits. Participants found to be eligible to continue in the study, will then enter the study drug period where they will take the study drug and have tests and procedures done about once a week for safety and for research purposes.

Participants who stop the study drug completely for any reason, will be asked to return to the clinic for an end of study drug visit about 28 days after their last dose of study drug to have tests and procedures done for safety and for research purposes. Participants that are experiencing any side effects during this time, will be closely followed by their study Doctor until the side effects have resolved or stabilized.

Participants who discontinue study drug for any reason other than disease progression, will be asked to have radiological imaging every 8 weeks to follow up on the status of their disease, until disease progression or the start a new treatment for their cancer.

After their final visit, the study nurse will call participants approximately every 3 months to check on the status of their health.

Details
Condition ROS1 Gene Rearrangement, ROS1 Rearrangement, MET Amplification, Non-squamous Non-small-cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, MET Activating Mutation, Non-squamous Non-small-cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Treatment Crizotinib
Clinical Study IdentifierNCT04084717
SponsorUniversity Health Network, Toronto
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: MET Amplification or ROS1 Gene Rearrangement or Non-squamous Non-small-cell Lung Cancer or MET Activating Mutation or Stage IV Non-small Cell Lung Can...?
Do you have any of these conditions: Stage IV Non-small Cell Lung Cancer or MET Amplification or MET Activating Mutation or ROS1 Rearrangement or Non-squamous Non-small-cell Lung Cancer o...?
Histologically or cytologically confirmed diagnosis of stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement (cohort
or MET-activating mutation (exon 14) (cohort 2) or MET-amplification (cohort 3)
years of age or older
Measurable disease as per RECIST v1.1
Adequate hematologic, cardiac and organ function within 7 days of the proposed start date of treatment
Life expectancy >12 weeks
Have the ability to understand and the willingness to sign a written informed consent document
Eastern Cooperative Oncology Group (ECOG) performance status 2
No contraindication to Crizotinib therapy
Able to swallow and retain oral medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
No pregnant
Agree to use methods (as agreed upon by the study doctor and participant) before the study and for at least 120 days after the last dose of study drug to prevent pregnancy

Exclusion Criteria

Symptomatic untreated brain metastases
Had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g. targeted therapy or antibodies) or radiotherapy within 4 weeks prior to the proposed first dose of study treatment
Adverse events attributed to prior anti-cancer therapy > Grade 1 if clinically relevant
Receiving medications or substances known to be strong inhibitors or inducers of CYP3A4
Any known intolerance to agents structurally similar to crizotinib
Congenital long QT syndrome or persistent corrected QT interval by Fredericia formula (QTcF) 500 msec
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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