/ Erasmus MC / NSCLC /
ORCHARD
2e lijns
EGFR
A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy (ORCHARD)
Stadium
IV
Mutatie
EGFR
Lijn
2e lijn na osimertinib
Site
Erasmuc MC
Population
Patients with advanced Non-Small Cell Lung Cancer and EGFR mutation hose disease has progressed on first-line osimertinib therapy
Design
Key outcome parameters
Intervention
n/a
Key inclusion criteria
Inclusion criteria:
- Histologically or cytologically confirmed adenocarcinoma of the lung (patients with mixed histology are eligible if adenocarcinoma is the predominant histology) harbouring EGFR mutation(s) known to be associated with EGFR TKI sensitivity at diagnosis
- Received only 1 line of therapy, with single-agent osimertinib, for advanced NSCLC, with clinical benefit as judged by investigator discretion
- WHO 0-1
Key exclusion criteria
Exclusion criteria:
- Patients whose disease has progressed within the first 3 months of osimertinib treatment (refractory to osimertinib treatment)
- Patients should not have discontinued osimertinib >60 days prior to the first dose of study treatment