Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Xiuning Le
Study ID
NCT03909334
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib 80 mg orally on Day 1
  • Ramucirumab — DRUG
    Ramucirumab 10 mg/kg intravenously (IV) over 60 minutes for first infusion and if tolerated subsequent infusions may be over 30 minutes

Study Details

The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.

Key Dates

Start date
Jul 25, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (Osimertinib and Ramucirumab)
    Osimertinib and Ramucirumab
  • Active Comparator: Arm B (Osimertinib)
    Osimertinib

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 3 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20057-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Indiana Univesity Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Summit Medical Group, PABerkeley HeightsNew Jersey07922-
Columbia University Irving Medical CenterNew YorkNew York10032-
New York University Cancer CenterNew YorkNew York10016-
Providence Portland Medical CenterPortlandOregon97213-
MD Anderson Cancer CenterHoustonTexas77030-
University of Virginia Health SystemCharlottesvilleVirginia22908-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Washington D.C., DC

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Georgetown University· Washington D.C., DCMoffitt Cancer Center· Tampa, FLNorthwestern University Feinberg School of Medicine· Chicago, ILRush University Medical Center· Chicago, ILIndiana Univesity Melvin and Bren Simon Cancer Center· Indianapolis, INSummit Medical Group, PA· Berkeley Heights, NJ

Related Studies