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 — DRUG
    may stop (or "inhibit") the growth of a cancer with a mutation in the EGFR gene
  • Selumetinib — DRUG
    may 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)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
Duke UniversityDurhamNorth Carolina27710-

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