A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT03392246
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Osimertinib — DRUGmay stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene
- Selumetinib — DRUGmay enhance the effect of osimertinib to stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene
Study Details
This research study is studying a combination of two targeted therapies as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The drugs involved in this study are: * Osimertinib (Tagrisso) * Selumetinib
Key Dates
- Start date
- Jan 31, 2018
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Osimertinib + Selumetinib* Selumetinib are to be administered orally intermittently (4 days on, 3 days off) * Osimertinib are to be administered orally on a daily basis
Primary Outcome Measure
Best Objective Response [ Time Frame: 2 years ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | - |
| Duke University | Durham | North Carolina | 27710 | - |
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