Pemetrexed vs Pemetrexed Plus Cisplatin in EGFR-mutant NSCLC Patients After First Line EGFR-TKIs Failure

Summary

The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial. The investigators hope to figure out the better chemotherapy regimen for the post-EGFR-TKI failure setting. The primary objective of this trial is to compare progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin and single-agent pemetrexed treatment arms. The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2 arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. Patients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.

Timeline

Start

2016-04-01

Primary completion

2020-12

Completion

2021-02

Publications

• Results Zeng Z, Yan HH, Zhang XC, Zhong WZ, He YY, Guan JL, Niu FY, Xie Z, Huang YS, Xu CR, Dong S, Wu YL. Reduced chemotherapy sensitivity in EGFR-mutant lung cancer patient with frontline EGFR tyrosine kinase inhibitor. Lung Cancer. 2014 Nov;86(2):219-24. doi: 10.1016/j.lungcan.2014.09.008. Epub 2014 Sep 18.
• Results Tseng JS, Yang TY, Chen KC, Hsu KH, Yu CJ, Liao WY, Tsai CR, Tsai MH, Yu SL, Su KY, Chen JJ, Chen HY, Chang GC. Prior EGFR tyrosine-kinase inhibitor therapy did not influence the efficacy of subsequent pemetrexed plus platinum in advanced chemonaive patients with EGFR-mutant lung adenocarcinoma. Onco Targets Ther. 2014 May 23;7:799-805. doi: 10.2147/OTT.S62639. eCollection 2014.
• Results Yang JJ, Chen HJ, Yan HH, Zhang XC, Zhou Q, Su J, Wang Z, Xu CR, Huang YS, Wang BC, Yang XN, Zhong WZ, Nie Q, Liao RQ, Jiang BY, Dong S, Wu YL. Clinical modes of EGFR tyrosine kinase inhibitor failure and subsequent management in advanced non-small cell lung cancer. Lung Cancer. 2013 Jan;79(1):33-9. doi: 10.1016/j.lungcan.2012.09.016. Epub 2012 Oct 15.
• Results Zinner RG, Obasaju CK, Spigel DR, Weaver RW, Beck JT, Waterhouse DM, Modiano MR, Hrinczenko B, Nikolinakos PG, Liu J, Koustenis AG, Winfree KB, Melemed SA, Guba SC, Ortuzar WI, Desaiah D, Treat JA, Govindan R, Ross HJ. PRONOUNCE: randomized, open-label, phase III study of first-line pemetrexed + carboplatin followed by maintenance pemetrexed versus paclitaxel + carboplatin + bevacizumab followed by maintenance bevacizumab in patients ith advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Jan;10(1):134-42. doi: 10.1097/JTO.0000000000000366.

Drugs

Indications