First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer
NCT03804580 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-05-07
Summary
Phase II, single-arm study to assess the safety and efficacy of osimertinib (80 mg, orally, once daily) as first-line therapy in patients with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously treated with an epidermal growth factor tyrosine kinase inhibitor agent.
Conditions
Interventions
- DRUG
-
Non-randomized trial, all patients receive therapy
Sponsors & Collaborators
-
Vestre Viken Hospital Trust
lead OTHER
Principal Investigators
-
Odd Terje Brustugun, MD PhD · Drammen Hospital - Vestre Viken
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-01
- Primary Completion
- 2025-06-01
- Completion
- 2025-12-31
Countries
- Denmark
- Lithuania
- Norway
- Sweden
Study Locations
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