In the early 1900s, lung cancer was a rare malignancy in women, but starting from the 1960s it has progressively reached epidemic proportions, surpassing breast cancer in 1987 and becoming the leading cause of cancer deaths in many countries. Retrospective data show that the 5-year survival rate for women who have lung cancer is 15.6%, compared with 12.5% for men, and this improved survival could have important implications in the design and interpretation of lung cancer trials. Women have major responses to therapy regardless of stage, therapeutic modalities or histology. The increase of lung cancer incidence among women is reflected in their clinical trial participation, causing a survival improvement and suggesting the need of stratification by sex in future studies. No specific drugs for women with lung cancer are currently available, but researchers are devoting energies in this area in order to better understand the implication of gender differences in epidemiology, pathogenesis, prognosis and tumor response.