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Clinical Trials/CTRI/2022/04/041861
CTRI/2022/04/041861
Active, not recruiting
Phase 3

Randomized, Open label, multicenter, Phase III study of Entrectinib versus Crizotinib in patients with locally Advanced or metastatic non-small cell Lung cancer harboring ROS1 gene rearrangements with and without Central Nervous system metastases

F HoffmannLa Roche Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Sponsor
F HoffmannLa Roche Ltd
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
F HoffmannLa Roche Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\. 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
  • •2\. 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
  • •3\. Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization. Patients who received brain irradiation must have completed whole brain radiotherapy at least 14 days prior and/or stereotactic radiosurgery at least 7 days prior to the start of entrectinib treatment.
  • •4\. Measurable systemic disease according to RECIST v1\.1
  • •5\. Life expectancy of at least 12 weeks
  • •6\. ECOG Performance Status of 0, 1, or 2
  • •7\. Adequate hematologic, renal, liver functions
  • •8\. 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
  • •9\. Ability to swallow entrectinib and crizotinib intact without chewing, crushing, or opening the

Exclusion Criteria

  • •1\. Current participation in another therapeutic clinical trial
  • •2\. 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
  • •3\. 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
  • •4\. History of recent (within the past 3 months) symptomatic congestive heart failure or ejection
  • •fraction ? 50% observed during screening for the study
  • •5\. History of prolonged corrected QT interval
  • •6\. History of additional risk factors for torsades de pointes
  • •7\. Grade \= 2 peripheral sensory neuropathy
  • •8\. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor\-induced pneumonitis
  • •9\. Previous malignancy within the past 3 years

Outcomes

Primary Outcomes

Not specified

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