Osimertinib In EGFR Mutant Lung Cancer
|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: NCT03586453|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : December 9, 2019
This research study is studying a targeted therapy as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.
The names of the study drug involved in this study is:
- Osimertinib (Tagrisso)
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Osimertinib||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
This research study is studying a targeted therapy as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR (epidermal growth factor receptor) genetic mutation. The EGFR gene produces a protein that helps cells divide. Specific changes or a mutation in the genetic information causes abnormal cell division and can lead to lung cancer. Patients who have NSCLC with an EGFR gene mutation can be treated by drugs called EGFR tyrosine kinase inhibitors (EGFR TKIs). They may stop (or "inhibit") the effect of the mutation in the EGFR gene.
- Osimertinib has been approved by the FDA (the U.S. Food and Drug Administration) for this disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Osimertinib With On-study and Post-progression Biopsy in the First Line Treatment of EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer|
|Actual Study Start Date :||August 13, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2023|
Osimertinib: Oral, once a day, dosage determined per protocol
Patients who fulfill eligibility criteria will be entered into the trial to receive Osimertinib.
After the screening procedures confirm participation in the research study:
- Mechanisms of resistance to Osimertinib [ Time Frame: 4 Months ]Evaluated by comparing the genomic changes using targeted next generation sequencing in the post-osimertinib tumor to the pre-treatment tumor specimen.
- Best objective response [ Time Frame: 6 months ]Best objective response will be evaluated via RECIST 1.1 criteria. RECIST1.1 measurements of CT scans will be measured every 2 cycles on treatment to determine the objective response rate for patients being treated with osimertinib.
- Overall Response Rate [ Time Frame: 3 years ]Defined as the proportion of patients with best response of CR or PR per investigator assessment using RECIST 1.1. start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started.
- Progression-free survival (PFS) [ Time Frame: 2 years ]Time from registration to documented disease progression or death from any cause, whichever occurs first. The Kaplan-Meier method will be used to determine the progression-free survival of patients enrolled on protocol and treated with combination osimertinib and selumetinib.
- Overall survival [ Time Frame: 2 years ]Survival follow-up with clinic visits or phone calls will be used to monitor for overall survival from time of study randomization to death from any cause. The Kaplan-Meier method will be used to calculate overall survival.
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): NCT03586453
|Contact: Pasi A Jänne, MD, PhD||877-338-7425||Pasi_Janne@dfci.harvard.edu|
|Contact: DFCI Clinical Trials Hotline||877-338-7425|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Daniel Costa, MD, PhD email@example.com|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: DFCI Clinical Trial Hotline 877-338-7425|
|Principal Investigator: Pasi Jänne, MD, PhD|
|Principal Investigator:||Pasi A Jänne, MD, PhD||Dana-Farber Cancer Institute|