Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Lung Cancer Home Page 2 NCI's gateway for information about lung cancer.

Name of the Trial

Phase II Randomized Study of Erlotinib With or Without Carboplatin and Paclitaxel in Patients With Chemotherapy-Naïve Select Stage IIIB or Stage IV Non-Small Cell Lung Cancer (CALGB-30406). See the protocol summary ³.

Principal Investigators

Dr. Pasi Janne Principal Investigator

Dr. Pasi Janne and Dr. Vincent Miller, Cancer and Leukemia Group B.

Why This Trial Is Important

The drug erlotinib (Tarceva) is approved to treat non-small cell lung cancer (NSCLC) that has not responded to chemotherapy (that is, as second-line therapy). However, the patients who benefited the most from erlotinib in the trial that led to its approval were those who had never smoked. Subsequent research has shown that "never smokers" have improved outcomes when treated with erlotinib because their cancers have specific mutations in a protein called epidermal growth factor receptor (EGFR), which is the target of erlotinib. In the presence of such mutations, erlotinib is particularly effective. It is important for the management of these patients, however, to compare the benefits of erlotinib alone or in combination with chemotherapy in first-line treatment.

In this trial, previously untreated NSCLC patients who never smoked or are former light smokers will be treated with either erlotinib alone or erlotinib in combination with the drugs carboplatin and paclitaxel.

"Lung cancer in nonsmokers is really a different disease than lung cancer in smokers," said Dr. Janne. "Nonsmokers are much more likely to have activating mutations in EGFR, and erlotinib seems to be effective in patients with such mutations.

"We hope to show that erlotinib, either given alone or in combination with chemotherapy, is useful as a first-line therapy for these patients," Dr. Janne commented.

Who Can Join This Trial

Researchers will enroll 180 patients with select stage IIIB or stage IV NSCLC who are either nonsmokers or former light smokers and have not received prior chemotherapy. See the list of eligibility criteria ⁴.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study contacts ⁵ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

Glossary Terms

Treatment with drugs that kill cancer cells.

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also called EGFR, ErbB1, and HER1.

A drug used to treat certain types of non-small cell lung cancer. It is also used together with gemcitabine to treat pancreatic cancer and is being studied in the treatment of other types of cancer. Erlotinib is a type of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Also called CP-358,774, erlotinib hydrochloride, OSI-774, and Tarceva.

Initial treatment used to reduce a cancer. First-line therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains. Also called induction therapy, primary therapy, and primary treatment.

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.