Clinical Trials /

Study of Crizotinib for ROS1 and MET Activated Lung Cancer

NCT04084717

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Crizotinib for ROS1 and MET Activated Lung Cancer
  • Official Title: Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)

Clinical Trial IDs

  • ORG STUDY ID: 18-5607
  • SECONDARY ID: CROME / WI235747
  • NCT ID: NCT04084717

Conditions

  • Non-squamous Non-small-cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • ROS1 Gene Rearrangement
  • MET Activating Mutation
  • MET Amplification

Interventions

DrugSynonymsArms
CrizotinibXALKORIROS1 Rearrangement

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
ROS1 RearrangementExperimentalPatients with stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement will be assigned to this arm.
  • Crizotinib
MET-activating Mutation (exon 14)ExperimentalPatients 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.
  • Crizotinib
MET-amplificationExperimentalPatients with stage IV or incurable non-squamous non-small cell lung cancer with a documented MET-amplification will be assigned to this arm.
  • Crizotinib

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response Rate
Time Frame:5 years
Safety Issue:
Description:Via RECIST 1.1

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University Health Network, Toronto

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