Patients with histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease
Conditions
Brief summary
Major Pathological Response (MPR) (≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post surgery)
Detailed description
Complete pathological Response (pCR) (absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery); EFS; DFS; Downstaging; Overall Survival (OS), Change from baseline in Patient reported outcomes (ePRO), Concordance of EGFRm status between tumour tissue DNA and patientmatched plasma-derived ctDNA, Concordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples., PK plasma concentrations of osimertinib
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) (≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete pathological Response (pCR) (absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery); EFS; DFS; Downstaging; Overall Survival (OS), Change from baseline in Patient reported outcomes (ePRO), Concordance of EGFRm status between tumour tissue DNA and patientmatched plasma-derived ctDNA, Concordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples., PK plasma concentrations of osimertinib | — |
Countries
Austria, Bulgaria, France, Germany, Italy, Poland, Spain