Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02971501
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Osimertinib — DRUG
    Given PO

Study Details

This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain (brain metastases). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop or slow non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving osimertinib with or without bevacizumab may work better in treating patients with non-small cell lung cancer.

Key Dates

Start date
Jun 27, 2018
Status verified
Dec 2025
Primary completion
Feb 18, 2025
Completion
Jul 1, 2026

Study Design

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

Arms

  • Experimental: Arm I (osimertinib, bevacizumab)
    Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.
  • Experimental: Arm II (osimertinib)
    Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From start of treatment to time of progression (in CNS or non-CNS disease) or death, whichever occurs first, assessed up to 63.7 months ]

Locations (18)

FacilityCityStateZIP
Los Angeles General Medical CenterLos AngelesCalifornia90033
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Keck Medical Center of USC PasadenaPasadenaCalifornia91105
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510
Yale UniversityNew HavenConnecticut06520
Moffitt Cancer CenterTampaFlorida33612
Moffitt Cancer Center-International PlazaTampaFlorida33607
University of Kansas Clinical Research CenterFairwayKansas66205
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205
Nebraska Medicine-BellevueBellevueNebraska68123
Nebraska Medicine-Village PointeOmahaNebraska68118
University of Nebraska Medical CenterOmahaNebraska68198
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By research site
Los Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAKeck Medical Center of USC Pasadena· Pasadena, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CASmilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CT

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