Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04227028
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Locally Advanced Lung Non-Small Cell Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Brigatinib — DRUG
    Given PO

Study Details

This phase Ib trial studies the side effects and best dose of brigatinib and how well it works with bevacizumab in treating patients with ALK-rearranged non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic) or has come back (recurrent). Brigatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if brigatinib and bevacizumab will work better in treating patients with ALK-rearranged non-small cell lung cancer.

Key Dates

First listed
Jan 13, 2020
Start date
Mar 9, 2020
Status verified
Jun 2026
Primary completion
Mar 25, 2027
Completion
Mar 25, 2027

Study Design

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

Arms

  • Experimental: Treatment (brigatinib, bevacizumab)
    Patients receive brigatinib PO QD on days 1-28 of cycle 1 and days 1-21 of subsequent cycles. Patients also receive bevacizumab IV on day 8 of cycle 1 and day 1 of subsequent cycles. Starting cycle 2, cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Within 30 days of treatment discontinuation or prior to start of next treatment ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
University of Colorado Cancer CenterAuroraColorado80045-
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Penn State Cancer InstituteHersheyPennsylvania17033-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAUniversity of Colorado Cancer Center· Aurora, CONorthwestern University· Chicago, ILRush University Medical Center· Chicago, ILPenn State Cancer Institute· Hershey, PAUniversity of Wisconsin Hospital and Clinics· Madison, WI

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