Combining Targeted Therapies for Newly Diagnosed Metastatic Lung Cancer

Name of the Trial

Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naïve Patients with Advanced, EGFR Mutation-Positive Non-Small Cell Lung Cancer (S1403). See the protocol summary.

Principal Investigator

Sarah B. Goldberg, M.D., Yale Cancer Center

Why This Trial Is Important  

About 10% of non-small cell lung cancer (NSCLC) cases are fueled by mutations in a gene called EGFR that increase the activity or amount of the EGFR protein, which promotes cell growth. People with this type of lung cancer tend to respond well to drugs called EGFR inhibitors that target the EGFR protein. However, in many cases these drugs eventually stop working as the cancer becomes resistant to the inhibitor.

In an effort to prevent resistance to EGFR inhibition from developing, doctors are exploring a number of options, including using two drugs at the same time that target the EGFR protein in different ways.

In this clinical trial, patients with newly diagnosed metastatic EGFR mutation-positive NSCLC will be randomly assigned to receive either the EGFR inhibitor afatinib (Gilotrif®) alone or afatinib together with another EGFR inhibitor, cetuximab (Erbitux®).

Doctors want to know if combining afatinib and cetuximab will help these patients live longer. They will also monitor progression-free survival and response rate, as well as try to identify biomarkers for response in both blood and tissue samples.

“Afatinib is approved by the Food and Drug Administration (FDA) for these patients, so all patients in the trial will receive standard therapy for their disease,” said Dr. Sarah Goldberg, the trial’s principal investigator. “Cetuximab is approved by the FDA for other types of cancer but is not currently approved for lung cancer.”

“We have studied the combination of afatinib and cetuximab in patients with EGFR mutation-positive lung cancer that has relapsed, and some patients did quite well on the combination," Dr. Goldberg said. “With this trial, we’re hoping to see if patients do better when given the combination as first-line therapy.”

For More Information

See the lists of eligibility criteria and trial contact information, or call the NCI Contact Center at 1-800-4-CANCER (1-800-422- 6237). The call is toll free and confidential.