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 : May 14, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | April 4, 2017 | ||||||
First Posted Date ICMJE | April 21, 2017 | ||||||
Last Update Posted Date | May 14, 2024 | ||||||
Actual Study Start Date ICMJE | May 9, 2017 | ||||||
Estimated Primary Completion Date | April 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles [ Time Frame: 3 years ] The feasibility of the concurrent and alternating dosing strategies for combination gefitinib/osimertinib 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.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer | ||||||
Official Title ICMJE | A Phase 1/2 Study of Osimertinib in Combination With Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer | ||||||
Brief Summary | 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:
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Gefitinib + Osimertinib
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
48 | ||||||
Original Estimated Enrollment ICMJE |
64 | ||||||
Estimated Study Completion Date ICMJE | April 2026 | ||||||
Estimated Primary Completion Date | April 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03122717 | ||||||
Other Study ID Numbers ICMJE | 16-627 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Pasi Janne, MD, PhD, Dana-Farber Cancer Institute | ||||||
Original Responsible Party | Amanda J. Redig, Dana-Farber Cancer Institute, Amanda J. Redig, MD, PhD | ||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | AstraZeneca | ||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||
Verification Date | May 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |