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NCI-Led Trial to Test EGFR as Marker for Lung Cancer Drug Response

NEW YORK (GenomeWeb News) – The National Cancer Institute said today that it is starting an initiative to validate if a biomarker can predict the clinical benefit of a chemotherapy drug for non-small cell lung cancer in certain patients.  
The study, called Marker Validation for Erlotinib in Lung Cancer, or MARVEL, will seek to find out if there is value in choosing patients for treatment with the drug based on the presence or absence of EGFR activation.
EGFR can be higher in some lung cancers due to the presence of extra copies of its coding gene, which can activate tumor growth. A drug that blocked that activation “could have a significant impact on lung cancer treatment,” NCI said.
MARVEL is a four-year, phase III study that will be run by the North Central Cancer Treatment Group and will include other NCI-sponsored clinical trial groups. It also will establish whether erlotinib delivers “a meaningful benefit” over the standard chemotherapy the patients received.
Under the program, researchers will test around 1,200 lung cancer patients for EGFR, and then randomly assign treatment with either erlotinib or pemetrexed after the patients have received their standard chemotherapy.
Erlotinib, sold under the brand name Tarceva by Genentech, specifically targets EGFR. Pemetrexed, which is called Alimta and is sold by Eli Lilly, blocks tumor cell growth by another mechanism.
The MARVEL program will test if erlotinib will be superior in patients with EGFR-positive lung cancer, and if pemetrexed would be better for treating patients with EGFR-negative lung cancer, as earlier studies have suggested. MARVEL researchers also will incorporate genetic studies for both drugs that will be useful in further identifying patients with different sensitivity and toxicity profiles to those therapies.
"Because lung cancer is such a lethal disease and because it is particularly difficult to treat, especially if diagnosed in its later stages, the MARVEL trial is of major importance because it could define, based on a single test, the best therapy for this disease,” NCI Director John Niederhuber said in a statement. “The future of moving highly targeted agents from the lab to the clinic will be heavily dependent on biomarkers for patient selection," he added.
The MARVEL study is the outcome of the Oncology Biomarkers Qualification Initiative, which was developed formed in 2006 between NCI, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services.
The trial also will include collaborative work from the Cancer and Leukemia Group B, the Eastern Cooperative Oncology Group, the Southwest Oncology Group, and the National Institute of Canada Clinical Trials Group, as well as industry partners.

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