AZD9291, an Irreversible EGFR-TKI, in Relapsed EGFR-mutated Non-small Cell Lung Cancer Patients Previously Treated With an EGFR-TKI, Coupled to Extensive Translational Studies (TREM)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02504346|
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : October 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Targeted Therapy||Drug: AZD9291||Phase 2|
This is a phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed following treatment with an approved epidermal growth factor tyrosine kinase inhibitor agent.
If feasible, subjects will have to provide a biopsy sample for molecular testing following confirmed disease progression on the most recent treatment regimen. A second biopsy will be sampled at progression on AZD9291, if feasible. Liquid biopsies will be sampled throughout the treatment period.
Subjects should continue on study treatment until RECIST 1.1-defined progression or until a treatment discontinuation criterion is met. There is no maximum duration of treatment as subjects may continue to receive investigational product beyond RECIST 1.1 defined progression as long as they are continuing to show clinical benefit, as judged by the investigator.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AZD9291, an Irreversible EGFR-TKI, in Relapsed EGFR-mutated Non-small Cell Lung Cancer Patients Previously Treated With an EGFR-TKI, Coupled to Extensive Translational Studies|
|Actual Study Start Date :||August 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||December 2020|
Non-randomized trial, all patients receive therapy - singel-arm
- Objective response rate [ Time Frame: 12 weeks ]Measured by RECIST 1.1
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): NCT02504346
|Oulu University Hospital|
|National Cancer Institute|
|Drammen Hospital - Vestre Viken HF|
|Drammen, Norway, N-3004|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0309|
|St Olavs hospital|
|Trondheim, Norway, N-7008|
|Karolinska University Hospital|