Background: Lung cancer remains a leading cause of death in US. Despite decrease in the overall lung cancer death rates, the reports of disparity by gender, age and race persist. Surveillance, Epidemiology, and End Results (SEER Data) from 2003-2007 results show that of patients diagnosed with lung cancer approximately 58% are men and 42% are women, 31.6% are < 65, 68.4% are >= 65 years of age and that the median age at diagnosis is 71 years of age. The incidence rate is higher for African Americans (73.5 per 100,000) compared with that for Caucasians (63.8 per 100,000). We reviewed trial data submitted for FDA drug approvals for the treatment of NSCLC over the last decade to see if the trial population represented the US population who were to receive these drugs. Methods: We reviewed our NDA and BLA files for agents approved to treat NSCLC from January 2000-December 2010.Within those applications, we analyzed the gender, age, and ethnicity data from ten pivotal trials. Results: Ten national and international trials enrolled a total of 8795 patients, 6015 (68.4%) males and 2780 (31.6%) females. The age group enrolled less than 65 years of age was 5656 (64.3%) and 3131 (35.6%) for the group more than 65 years and approximate median age for all the trials was 60 years. Ethnicity results showed the enrollment of Caucasians 6892(78.4%), Asians 1325 (15%), Blacks 194 (2.2%), Hispanics 184 (2%) and other 200 (2.3%). Conclusions: Our results suggest that the trial population used for approvals do not represent well the US population who may receive the marketed agent. Women, Blacks, and the elderly were less frequently enrolled in trials. Disparity was especially pronounced in the age and ethnicity. This fact is concerning particularly for older patients who may experience greater toxicity when given the same dose and combination of drugs based on testing in younger population. The enrollment of Blacks was only 2.2%. Efforts should be made to encourage enrollment and participations in clinical trials by ethnic and racial minorities and older age group who are more prevalent to receive these therapies.