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.
An NCCN study funded through the grant mechanism is highlighted below.
Randomized Phase II Study Comparing Concise (3 Months) Versus Prolonged (2 Years) Afatinib as Adjuvant Therapy for Patients With Resected Stage I–III Non–Small Cell Lung Cancer With EGFR Mutation
Principal Investigator: Lecia Sequist, MD, MPH
Condition: Non–small cell lung cancer
Institution: Massachusetts General Hospital Cancer Center
This is a randomized, phase II study for patients with resected stage I–III non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation who have completed standard adjuvant therapy, which may include platinum-based chemotherapy and/or radiation. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. The goal of this study is to determine whether taking afatinib after surgery for NSCLC works better when taken over a short period compared with a long period. Treatment assignment will be stratified by stage. Patients will be randomized to either a concise course of afatinib (daily oral dose for 3 months = Arm A) or prolonged therapy with afatinib (daily oral dose for 2 years = Arm B).
Primary Objective:
Demonstrate that prolonged adjuvant therapy with afatinib will improve recurrence free survival compared with a concise adjuvant course in patients with resected stage I–III NSCLC with EGFR mutation
Secondary Objectives:
Determine the safety and tolerability of adjuvant afatinib
Collect clinical data from patients with recurrent NSCLC after treatment with adjuvant afatinib (ie, time to recurrence, sites of recurrence, histology of recurrence) and molecular characteristics of recurrent cancer analyzed as part of routine care (ie, EGFR genotype, markers of EGFR tyrosine kinase inhibitor resistance)
Estimate overall survival
Contact: Lecia Sequist, MD, MPH • 617-724-4000
ClinicalTrials.gov Identifier: NCT01746251
The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.
For more information on specific trials, including patient selection criteria, please 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, please access the NCCN ORP pages at NCCN.org/clinical_trials/clinicians.asp.
