Highlights of the NCCN Oncology Research Program

The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program’s establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.

NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.

This feature highlights an NCCN study funded through the grant mechanism.

Phase I Trial of Combination Afatinib and Necitumumab in EGFR Mutation–Positive Non–Small Cell Lung Cancer With Acquired Resistance to First- or Third-Generation EGFR Tyrosine Kinase Inhibitors

Principal Investigator: Leora Horn, MD

Condition: Non–small cell lung cancer

Institution: Vanderbilt-Ingram Cancer Center

This phase I clinical trial is studying the side effects and best dose of afatinib and necitumumab to see how well they work in treating patients with EGFR mutation–positive non–small cell lung cancer (NSCLC) 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 NSCLC.

Primary Objective:

  • Determine maximum tolerated dose of combination afatinib and necitumumab therapy in patients with EGFR mutation–positive NSCLC that has progressed after first- and third-generation EGFR tyrosine kinase inhibitors (TKIs)
  • Determine efficacy and safety profile of afatinib and necitumumab combination therapy in patients with EGFR mutation–positive NSCLC that has progressed after first- and third-generation EGFR TKIs, as well as while on first-line osimertinib

Contact: Clinical Trials Information Program • 800-811-8480 • cip@vanderbilt.edu

ClinicalTrials.gov Identifier: NCT03054038

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For more information on specific trials, including patient selection criteria, use the contact information listed with each study.

For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, go to www.NCCN.org/clinical_trials/clinicians.asp.


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