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
