Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS)

Sponsor
University Hospital, Essen
Study ID
NCT03810066
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    All patients will be treated with osimertinib 80 mg/d for one cycle (28 days).

Study Details

This is a single arm, open label, multicentric proof-of-concept, phase II study in patients with EGFR-mutated non-small-cell lung cancer (NSCLC) with acquired TKI resistance who are "unknown" for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a standard plasma genotyping assay. All patients will receive osimertinib as continuous oral treatment for one cycle (28 days). Patients who demonstrate a metabolic response by FDG-PET scanning (to be conducted between day 15 and day 28 of cycle 1) will continue treatment until clinical or radiological progression. Osimertinib treatment will be terminated in patients not experiencing a metabolic response. Primary objective: To study the rate of early metabolic responses to osimertinib in patients with EGFR-mutated NSCLC and acquired TKI resistance who are "unknown" for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a standard plasma genotyping assay.

Key Dates

Start date
Jun 3, 2019
Status verified
May 2024
Primary completion
Dec 31, 2021
Completion
Sep 30, 2022

Study Design

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

Arms

  • Experimental: Osimertinib

Primary Outcome Measure

Rate of metabolic responses [ Time Frame: 28 days ]

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