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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2027
  • participants needed
    220
  • sponsor
    Hoffmann-La Roche
Updated on 13 July 2022
tyrosine
systemic therapy
kinase inhibitor
progressive disease
ROS1
cancer chemotherapy
crizotinib
lung carcinoma
proto-oncogene tyrosine-protein kinase ros

Summary

The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment Crizotinib, Entrectinib
Clinical Study IdentifierNCT04603807
SponsorHoffmann-La Roche
Last Modified on13 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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) NSCLC
Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization
Measurable systemic disease according to RECIST v1.1
Participants with measurable and non-measurable CNS lesions per RECIST v1.1, including leptomeningeal carcinomatosis
Life expectancy of at least 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Adequate hematologic, renal, liver functions
Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
Ability to swallow entrectinib and crizotinib intact without chewing, crushing, or opening the capsules
For 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 crizotinib
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

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) NSCLC
NCI-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 drug
History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤ 50% observed during screening for the study
History of prolonged corrected QTc interval
Peripheral sensory neuropathy ≥ Grade 2
Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
Previous malignancy within the past 3 years
Incomplete recovery from any surgery prior to the start of study treatment
Active GI disease (e.g., Crohn's disease, ulcerative colitis or short gut syndrome) or other malabsorption syndrome that would reasonably impact drug absorption
History of prior therapy-induced pneumonitis
Any 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 medication
Known 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 formulations
Pregnant or lactating women
Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illness
Any 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
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