Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04084717
Previous Study | Return to List | Next Study

Study of Crizotinib for ROS1 and MET Activated 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084717
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE September 8, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date September 28, 2020
Actual Study Start Date  ICMJE December 3, 2019
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • Response Rate [ Time Frame: 5 years ]
    Via RECIST 1.1
  • Progression-free survival [ Time Frame: 5 years ]
    Via RECIST 1.1
  • Average Time-to-treatment Failure [ Time Frame: 5 years ]
    Time from randomization to treatment discontinuation for any reason
  • Edmonton Symptom Assessment Scale (ESAS) Score [ Time Frame: 5 years ]
    Patient related symptom improvement evaluated by ESAS
  • EQ5D-3L Questionnaire Score [ Time Frame: 5 years ]
    Patient preference/health related utility evaluated by EQ5D-3L Questionnaire
  • Overall survival [ Time Frame: 2 years ]
    Number of days from the date of randomization to the date of death
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2019)
  • Response Rate [ Time Frame: 5 years ]
    Via RECIST 1.1
  • Progression-free survival [ Time Frame: 5 years ]
    Via RECIST 1.1
  • Average Time-to-treatment Failure [ Time Frame: 5 years ]
    Time from randomization to treatment discontinuation for any reason
  • Edmonton Symptom Assessment Scale (ESAS) Score [ Time Frame: 5 years ]
  • EQ5D-3L Questionnaire Score [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 2 years ]
    Number of days from the date of randomization to the date of death
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Crizotinib for ROS1 and MET Activated Lung Cancer
Official Title  ICMJE Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be assigned to one of the following:

Cohort 1 - ROS1 rearrangement Cohort 2 - MET-activating mutation (exon 14) Cohort 3 - MET-amplification

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-squamous Non-small-cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • ROS1 Gene Rearrangement
  • MET Activating Mutation
  • MET Amplification
Intervention  ICMJE Drug: Crizotinib

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.

Other Name: XALKORI
Study Arms  ICMJE
  • Experimental: ROS1 Rearrangement
    Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement will be assigned to this arm.
    Intervention: Drug: Crizotinib
  • Experimental: MET-activating Mutation (exon 14)
    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.
    Intervention: Drug: Crizotinib
  • Experimental: MET-amplification
    Patients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-amplification will be assigned to this arm.
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement (cohort 1) or MET-activating mutation (exon 14) (cohort 2) or MET-amplification (cohort 3).
  • 18 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Natasha Leighl, M.D. 416-946-4645 natasha.leighl@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04084717
Other Study ID Numbers  ICMJE 18-5607
CROME / WI235747 ( Other Identifier: Princess Margaret Cancer Centre )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Natasha Leighl, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP