About ten years ago, docetaxel was established as a second-line chemotherapy for advanced non-small cell lung cancer(NSCLC). After that, pemetrexed has been shown to be similar to docetaxel in response rate, overall survival and progression-free survival, and to have a more favorable toxicity profile. As a result, pemetrexed was approved in the US and Europe. On the other hand, EGFR TKI has been compared to docetaxel or best supportive care in phase III trials. Based on these results, EGFR-TKI is now considered one of the treatment options in a second-line setting for NSCLC. Recently, it has been shown that EGFR-TKIs are very effective against EGFR mutation-positive NSCLC in many reports. Thus, EGFR-TKIs are examined as first-line chemotherapy against those patients. Since, other molecular- targeted drugs except for EGFR-TKI have been developed, we hope for the establishment of further effective second- line treatment for NSCLC. As for small cell lung cancer, phase III trials for second-line treatment are few. Topotecan is the only agent which has been proved to show a significant prolongation of survival for the best supportive care. In Japan, amrubicin is considered an effective agent for relapsed small cell lung cancer. We hope to reveal the efficacy of amrubicin in randomized phase III trials.