Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02520778
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Lung Non-Squamous Non-Small Cell Carcinoma
  • Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
  • Stage III Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Non-Small Cell Cancer AJCC v7
  • Stage IV Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • Navitoclax — DRUG
    Given PO
  • Osimertinib — DRUG
    Given PO

Study Details

This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread to other places in the body (metastatic) or has not responded to previous treatment with initial EGFR kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Aug 30, 2016
Status verified
Aug 2024
Primary completion
Oct 26, 2022
Completion
Dec 4, 2023

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (navitoclax, osimertinib)
    Patients receive navitoclax PO QD on days 1-28 and osimertinib PO QD on days 4-28 (days 1-28 during dose-expansion). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

Primary Outcome Measure

Incidence of toxicity (dose escalation) [ Time Frame: Up to 2 years ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCHealth University of Colorado HospitalAuroraColorado80045-
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center-International PlazaTampaFlorida33607-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Duke Raleigh HospitalRaleighNorth Carolina27609-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CAUCHealth University of Colorado Hospital· Aurora, COMoffitt Cancer Center· Tampa, FLMoffitt Cancer Center-International Plaza· Tampa, FLEmory University Hospital/Winship Cancer Institute· Atlanta, GAUniversity of Kentucky/Markey Cancer Center· Lexington, KY

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