Clinical trial evaluating efficacy and safety of pemetrexed based chemotherapy regimen versus ramucirumab plus erlotinib in Chinese patients with lung cancer: A preliminary investigation

Abstract

To carry out a preliminary clinical trial to compare the effectiveness and safety of pemetrexed based chemotherapy regimen in combination of cisplatin versus ramucirumab plus erlotinib in Chinese patients with metastatic non-small-cell lung cancer (NSCLC). Patients with confirmed diagnosis of NSCLC were randomly (1:1 ratio) grouped and treated intravenously with a mixture of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) plus Best Supportive Care (BSC), or ramucirumab (8 mg/kg) intravenously (IV) + erlotinib 25 mg/day. Overall survival (OS), overall response rate (ORR), progression free survival (PFS), and the safety were assessed. Pemetrexed based chemotherapy regimen in combination of cisplatin showed significantly higher OS (14.4 months vs. 10.47 months, p<0.05) and PFS (9.5 months vs. 5.1 months) than ramucirumab plus erlotinib. Objective response was also favorable in the patients treated with pemetrexed based chemotherapy regimen, when compared with those given ramucirumab plus erlotinib. Pemetrexed based chemotherapy regimen found more effective to ramucirumab plus erlotinib in improving OS, PFS and ORR, and it offers greater clinical benefits than ramucirumab plus erlotinib in Chinese NSCLC patients. Pemetrexed based chemotherapy regimen in combination of cisplatin appears to be better choice of drug for the treatment of Chinese patients with advanced stage of lung cancer.