Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
Interim report on CIV recombinant human endostatin in combination with docetaxel/cisplatin (DP)) in comparison to DP in the first-line treatment of phase IIIb/IV squamous-cell NSCLC (JSLCG-001): A multicenter, open-label, randomized phase III controlled study (NCT: 02513342).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr e20541)
Author(s): Jian'An Huang, Yong Song, Minhua Shi, Jian Feng, Xuedong Lv; The First Affiliated Hospital of Soochow University, Suzhou, China; Nanjing General Hospital of Nanjing Military Command (NGH)- Jinling Hospital, Nanjing, China; The 2nd Affiliated Hospital of Soochow University, Suzhou, Jianasu, China; Affiliated Hospital of Nantong University, Nantong, China; Respiratory Dept., The First People Hospital of Nantong, Nantong, China, Nantong, China
Background: Endostar registration Phase III and post-marketing Phase IV clinical study had confirmed Endostar in combination with Platinum double drugs can improve the NSCLC patients’ outcomes of ORR, PFS and OS. However, It influenced on the patients’ compliance for Endostar day 1-14 intravenous infusion (I.V). Endostar day 1-7 continuous intravenous infusion (CIV) can have the compliance improved obviously. So, we carried out this phase III trial to confirm the efficacy and safety of CIV Endostar in combination with DP regimen for first line treatment of phase IIIB/IV squamous-cell NSCLC. Methods: The planed 188 patients with phase IIIB/IV squamous-cell NSCLC without the history of chemotherapy would be randomly assigned to receive Endostar and DP (Endostar, 15mg/m2/d, civ, d1-7; Docetaxel, 60mg/m2/d, iv, d4; Cisplatin, 75mg/m2/d, iv, d4), or DP (Docetaxel, 60mg/m2/d, iv, d1; Cisplatin, 75mg/m2/d, iv, d1). The cycle was every 3 weeks and 4-6 cycles would be needed in total in each groupl. After 4-6 cycles, CIV Endostar in Endostar+DP group would maintain till PD. The primary end point was PFS. Results: The interim data from 94 cases was included in the analysis. The median PFS in Endostar+DP group was 6.8 months ( 95% CI, 4.0-9.6) versus 3.1 months ( 95% CI, 2.9-3.4) in DP group ( P = 0.024 ). The response rate was 33% in Endostar+DP versus 31% in DP group ( P = 0.838 ). The AEs in each group was comparable. No unexpected AEs in Endostar+DP was found. Conclusions: This preliminary result showed Endostar in combination with DP improved PFS significantly (P = 0.024). Among patients with advanced, previously untreated squamous-cell NSCLC, the longer PFS was related to CIV Endostar on the duration of maintenance. Clinical trial information: NCT02513342