TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy

Sponsor
Asan Medical Center
Study ID
NCT03394118
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    A cycle of study treatment is defined as 28 days. Each subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily.

Study Details

In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy.

Key Dates

Start date
Aug 11, 2017
Status verified
Apr 2021
Primary completion
Mar 11, 2021
Completion
Apr 8, 2021

Study Design

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

Arms

  • Experimental: Group_TAGRISSO
    Each subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period.

Primary Outcome Measure

ORR [ Time Frame: through study completion (43 months) ]

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