Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03122717|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : November 17, 2020
This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.
The interventions involved in this study are:
- Osimertinib (Tagrisso)
- Gefitinib (Iressa)
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Gefitinib Drug: Osimertinib||Phase 1 Phase 2|
This research study is a Phase I clinical trial, which tests the safety of investigational drugs and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has approved gefitinib and osimertinib as separate treatment options for this disease. The FDA has not approved the combination of these study drugs as a treatment option for this disease.Recently, the FDA approved osimertinib as a first-line treatment for patients that have NSCLC with an EGFR mutation, that have not received prior treatment for their disease.
In this research study, the investigators are evaluating the combination of gefitinib and osimertinib in patients who have just been diagnosed with non-small cell lung cancer containing a mutation in the epidermal growth factor receptor (EGFR) gene.
Normally, cells in the body divide in an orderly way. However, in cancer cells, this normal process of cell division becomes abnormal and allows the cancer cells to grow in a rapid, unregulated way. In some patients with lung cancer, this abnormal and rapid growth in the cancer cells is drive by a specific change in a gene called the Epidermal Growth Factor Receptor (EGFR). This change in the EGFR gene in cancer cells is called a mutation. Patients with lung cancer harboring a mutation in EGFR can be treated with specific drugs called EGFR inhibitors. However, even though these drugs can be very effective, after a period of time, most EGFR tumors will develop resistance to this treatment, most often because of a second mutation in EGFR called T790M.
Right now, patients with newly diagnosed lung cancer with an EGFR mutation would be treated with a single EGFR inhibitor. A drug like gefitinib is a standard first treatment for patients with this kind of lung cancer. Osimertinib is currently approved only to treat patients whose cancers develop resistance to gefitinib (or other similar EGFR inhibitors) because of the T790M mutation.
However, ongoing clinical trials have shown that osimertinib is also effective when used as the first treatment in newly diagnosed patients with lung cancer containing an EGFR mutation. In addition, laboratory studies have shown that combining EGFR inhibitors may help prevent the development of drug resistance.
The goal of this particular study is to evaluate two different methods of combining gefitinib and osimertinib in newly diagnosed patients with EGFR mutations: either with both drugs given together on the same day OR an alternating schedule where participants will alternate taking one drug at a time every 4 weeks.
This study will help determine the optimal dosing strategy for combining these two drugs in lung cancer patients with EGFR mutations. The study will also follow the clinical response of participants treated with the drug combination to monitor how well and how long this strategy controls the disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of Osimertinib in Combination With Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer|
|Actual Study Start Date :||May 9, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2023|
Experimental: Gefitinib + Osimertinib
gefitinib is a EGFR inhibitor
Other Name: Iressa
An orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor
Other Name: Tagrisso
- Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles [ Time Frame: 3 years ]The feasibility of combination gefitinib/osimertinib dosing will be determined through evaluation of the number of patients in each cohort who are able to remain on combination therapy for 6 x 28 day cycles.
- Rate of treatment-related Grade 3-5 adverse events [ Time Frame: 3 years ]CTCAE v4.0 will be used to monitor toxicities in patients on combination therapy with gefitinib and osimertinib.
- Objective response rate [ Time Frame: 3 years (each cycle is 28 days) ]RECIST 1.1 measurements of CT scans of the chest/abdomen/pelvis will be measured every 2 cycles on treatment to determine the objective response rate for patients being treated with combination gefitinib and osimertinib.
- Progression free survival [ Time Frame: 3 years ]The Kaplan-Meier method will be used to determine the progression-free survival of patients enrolled on protocol and treated with combination gefitinib and osimertinib.
- Overall Survival [ Time Frame: 3 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): NCT03122717
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Pasi Janne, MD, PhD||Dana-Farber Cancer Institute|