Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT03054038
Phase
PHASE1
Status
Terminated

Conditions

  • Non-Small Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

  • Afatinib — DRUG
    Given by mouth
  • Necitumumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of afatinib and necitumumab and to see how well they work in treating patients with EGFR mutation positive non-small cell lung cancer that has spread to other places in the body. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving afatinib and necitumumab may work better in treating patients with EGFR mutation positive non-small cell lung cancer.

Key Dates

Start date
Jul 20, 2017
Status verified
Apr 2022
Primary completion
Mar 23, 2022
Completion
Mar 23, 2022

Study Design

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

Arms

  • Experimental: Experimental
    Patients receive afatinib PO QD on days 1-28 and necitumumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose experience a dose-limiting toxicity [ Time Frame: Up to 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Stanford Cancer InstituteStanfordCalifornia94035-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAStanford Cancer Institute· Stanford, CAVanderbilt-Ingram Cancer Center· Nashville, TN

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