Last updated 29 days ago
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
220 patients around the world
Available in Mexico, Brazil, Spain
Hoffmann-La Roche
9Research sites
220Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement.No prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLCPrior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomizationMeasurable systemic disease according to RECIST v1.1Participants with measurable and non-measurable CNS lesions per RECIST v1.1, including leptomeningeal carcinomatosisLife expectancy of at least 12 weeksEastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2Adequate hematologic, renal, liver functionsParticipants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatmentAbility to swallow entrectinib and crizotinib intact without chewing, crushing, or opening the capsulesFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the treatment period and for up to 5 weeks after the last dose of entrectinib or for at least 90 days after the last dose of crizotinibFor men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
- Prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLCNCI-CTCAE v5.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia, fatigue, nausea and lack of appetite), which have not shown improvement and are strictly considered to interfere with current study drugHistory of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤ 50% observed during screening for the studyHistory of prolonged corrected QTc intervalPeripheral sensory neuropathy ≥ Grade 2Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitisPrevious malignancy within the past 3 yearsIncomplete recovery from any surgery prior to the start of study treatmentActive GI disease (e.g., Crohn's disease, ulcerative colitis or short gut syndrome) or other malabsorption syndrome that would reasonably impact drug absorptionHistory of prior therapy-induced pneumonitisAny condition (in the past 3 months) e.g., myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, stroke, symptomatic bradycardia, or uncontrolled arrhythmias requiring medicationKnown active infections (bacterial, fungal or viral, including human immunodeficiency virus positive)History of hypersensitivity to any of the additives in the entrectinib and/or crizotinib drug formulationsPregnant or lactating womenKnown human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illnessAny clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications.
Sites
Ynova Pesquisa Clinica
Recruiting
Hospital Sao Rafael
Recruiting
Oncocentro Serviços Médicos e Hospitalares Ltda
Recruiting
Oncocentro - Belo Horizonte
Recruiting
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Recruiting
Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González
Recruiting
Health Pharma Professional Research
Recruiting
Superare - Centro de Infusión
Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Recruiting
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04603807
