Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

Sponsor
Seoul National University Hospital
Study ID
NCT03414814
Phase
PHASE2
Status
Completed

Conditions

  • Locally Advanced or Metastatic NSCLC

Eligibility Criteria

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

Interventions

Study Details

This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.

Key Dates

Start date
Jan 4, 2018
Status verified
Jan 2025
Primary completion
Aug 3, 2021
Completion
Aug 3, 2021

Study Design

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

Arms

  • Experimental: Osimertinib
    Osimertinib at 80mg dose will be administered orally once daily.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months) ]

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