Studies Nieuws Nieuwsbrief Over ons Archief
Zoek beschikbare studies

Studieoverzicht

Study name: MO41552

Histology NSCLC, all subtypes
Tumor stage Stage I - IIIStage III - IV
Host / recruiting site 1 Antoni van Leeuwenhoek Enrollment Closed
Host / recruiting site 2 Erasmus MC Enrollment Closed
Host / recruiting site 3 Radboud UMC Enrollment Closed
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 NSCLC
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
Contact information