lymph done negative NSCLC harboring a sensitizing EGFR mutation, lymph-node negative Non-small Cell Lung Cancer Osimertinib cohort: Open-label, Main cohort: Patients with unresected Stage I/II, Single arm for patients with unresected stage I/II
Conditions
Brief summary
Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR, Applicable to osimertinib cohort: 4-years PFS by ICR using RECIST 1.1
Detailed description
Applicable to main cohort: PFS in patients with T1 to T3N0M0 NSCLC; Overall Survival; PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1; PFS2 using local assessment; PK of durvalumab in serum; Presence of ADA for durvalumab; EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life; Safety and tolerability:AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings, Applicable to osimertinib cohort: AEs (graded by CTCAE version 5); Laboratory studies: chemistry, hematology, and urinalysis; Clinical evaluations; ECG parametres; LVEF; WHO performance status; PFS using RECIST 1.1; OS; Site(s) of disease progression; Time to CNS progression; TTP; PFS2
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR, Applicable to osimertinib cohort: 4-years PFS by ICR using RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Applicable to main cohort: PFS in patients with T1 to T3N0M0 NSCLC; Overall Survival; PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1; PFS2 using local assessment; PK of durvalumab in serum; Presence of ADA for durvalumab; EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life; Safety and tolerability:AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings, Applicable to osimertinib cohort: AEs (graded by CTCAE version 5); Laboratory studies: chemistry, hematology, and urinalysis; Clinical evaluations; ECG parametres; LVEF; WHO performance status; PFS using RECIST 1.1; OS; Site(s) of disease progression; Time to CNS progression; TTP; PFS2 | — |
Countries
Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Spain