Tarceva NSCLC Trial of Nonsmokers Only

• BETHESDA, Maryland—Investigators have begun enrolling a select group of non-small-cell lung cancer (NSCLC) patients—those who have never smoked or once smoked lightly—into a phase II trial to determine whether erlotinib (Tarceva), with or without chemotherapy, is effective as first-line treatment. The pivotal Tarceva study for second-line use in NSCLC showed that patients who had never smoked benefited the most. Research has since shown that nonsmokers benefit more because they have specific mutations in EGFR.

Researchers from the Cancer and Leukemia Group B are conducting the randomized, multicenter trial (CALGB 30406). They expect to accrue 180 NSCLC patients to the study at 50 sites in 20 states and the District of Columbia. Pasi Janne, MD, PhD, of Dana-Farber, and Vincent Miller, MD, of Memorial Sloan-Kettering, are co-principal investigators. Patients will receive oral erlotinib once daily on days 1 to 21 of each 3-week cycle or erlotinib in the same manner plus, on day 1, IV paclitaxel and carboplatin, up to six courses. Patients who complete the six courses may continue on erlotinib. More details of the study are available at www.clinicaltrials.gov (search under NCT00126581), or at www.cancer.gov/clinicaltrials/CALGB-30406.