First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer

Sponsor
Vestre Viken Hospital Trust
Study ID
NCT03804580
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • osimertinib — DRUG
    Non-randomized trial, all patients receive therapy

Study Details

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.

Key Dates

Start date
Dec 1, 2018
Status verified
May 2024
Primary completion
Jun 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: osimertinib
    All patients recieve osimertinib

Primary Outcome Measure

Objective response rate [ Time Frame: 12 weeks ]

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