Studieoverzicht

Study name: MO41552

Histology	NSCLC
Tumor stage	Stage I - III, Stage IV
Host / recruiting sites	Antoni van Leeuwenhoek, Erasmus MC, Radboud UMC
Enrollment	Recruiting
Design	Randomized, open-label, multicenter, Phase III trial
Intervention	Arm A: Entrectinib Arm B: Crizotinib
Key outcome parameters	To evaluate the efficacy of entrectinib compared with crizotinib in patients who have ROS1 rearrangement-Positive NCLC
Key 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 ECOG Performance Status of 0,1 or 2
Key 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 ECOG Performance Status of 0,1 or 2 Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
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