Study of Crizotinib for ROS1 and MET Activated Lung Cancer

NCT04084717 | Recruiting Phase 2 DMC

• 2 other identifiers: 18-5607CROME / WI235747
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Response Rate

  Via RECIST 1.1

  5 years

• Progression-free survival

  Via RECIST 1.1

  5 years

• Average Time-to-treatment Failure

  Time from randomization to treatment discontinuation for any reason

  5 years

• Edmonton Symptom Assessment Scale (ESAS) Score

  Patient related symptom improvement evaluated by ESAS

  5 years

• EQ5D-5L Questionnaire Score

  Patient preference/health related utility evaluated by EQ5D-5L Questionnaire

  5 years

• Overall survival

  Number of days from the date of randomization to the date of death

  2 years

Study Arms (3)

ROS1 Rearrangement

EXPERIMENTAL

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-amplification

EXPERIMENTAL

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

Crizotinib DRUG

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.

Also known as: XALKORI

MET-activating Mutation (exon 14); MET-amplification; ROS1 Rearrangement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) tested in either plasma or tissue, as applicable
• years of age or older.
• Measurable disease as per RECIST v1.1.
• Adequate hematologic and organ function within 7 days of the proposed start date of treatment and adequate cardiac function within 28 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

You may not qualify if:

• Symptomatic untreated brain metastases.
• Had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g. targeted therapy or antibodies) within 4 weeks or radiotherapy within 2 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Pfizer: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Natasha Leighl, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Leighl, M.D.

CONTACT

416-946-4645; natasha.leighl@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of the following: Cohort 1 - ROS1 rearrangement Cohort 2 - MET-activating mutation (exon 14) Cohort 3 - MET-amplification

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 10, 2019
• Study Start: December 3, 2019
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CA (1)