Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03810066|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : July 17, 2019
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|NSCLC EGFR T790M FDG-PET||Drug: Osimertinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS) - A Multicentric Phase II Study in Patients With TKI-resistant EGFR-mutated Lung Cancer Exhibiting Early Metabolic Response to Osimertinib|
|Actual Study Start Date :||June 3, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
All patients will be treated with osimertinib 80 mg/d for one cycle (28 days).
- Rate of metabolic responses [ Time Frame: 28 days ]Rate of metabolic responses as detected by FDG-PET before end of cycle 1. One cycle is defined as 28 days continuous treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810066
|Contact: Martin Schuler, Prof. Dr. med.||+49-201-723 firstname.lastname@example.org|
|Prof. Dr. med. Martin Schuler||Recruiting|
|Essen, NRW, Germany, 45147|
|Principal Investigator: Martin Schuler, Prof. Dr. med.|