التفاصيل البيبلوغرافية
| العنوان: |
Phase II, open-label, multicenter trial of crizotinib in Japanese patients with advanced non-small cell lung cancer harboring a MET gene alteration: Co-MET study. |
| المؤلفون: |
Shimokawa, Mototsugu1,2 (AUTHOR) moto@yamaguchi-u.ac.jp, Nosaki, Kaname3,4 (AUTHOR), Seto, Takashi3 (AUTHOR), Ohashi, Kadoaki5 (AUTHOR), Morise, Masahiro6 (AUTHOR), Horinouchi, Hidehito7 (AUTHOR), Sakakibara, Jun8 (AUTHOR), Murakami, Haruyasu9 (AUTHOR), Yano, Seiji10 (AUTHOR), Satouchi, Miyako11 (AUTHOR), Matsumoto, Shingo4 (AUTHOR), Goto, Koichi4 (AUTHOR), Yoh, Kiyotaka4 (AUTHOR) |
| المصدر: |
Trials. 3/30/2020, Vol. 21 Issue 1, p1-6. 6p. 1 Diagram, 2 Charts. |
| مصطلحات موضوعية: |
*NON-small-cell lung carcinoma, *CLINICAL trial registries, *BINOMIAL distribution, *BRAF genes, *PATIENT safety |
| الشركة/الكيان: |
UNIVERSITY of Colorado Hospital |
| مستخلص: |
Background: MET-deregulated non-small cell lung cancer represents an urgent clinical need because of the lack of specific therapies. Although recent studies have suggested a potential role for crizotinib in patients harboring MET gene alterations, no conclusive data are currently available. Therefore, we designed the Co-MET study, a single-arm phase II study to assess the efficacy and safety of crizotinib in patients with advanced non-small cell lung cancers harboring MET gene alterations.Methods: Co-MET is an open-label, multi-center, single-arm, phase II trial to assess the safety and efficacy of oral crizotinib in patients with advanced non-small cell lung cancer harboring MET exon 14 skipping mutation (cohort 1) or a high MET gene copy number of ≥ 7 (cohort 2). We will identify MET gene alterations using RT-PCR and/or next-generation sequencing. Oral crizotinib 250 mg BID will be administered until disease progression or unacceptable toxicity. A radiology committee will review tumor scans according to the RECIST criteria. The primary endpoint is the objective response rate. Assuming a null hypothesis of 20% objective response rate and an alternative hypothesis of 50% objective response rate for cohort 1, and a one-sided alpha error of 0.05 and 80% power based on the exact binomial distribution, the required number of evaluable patients is 19. We set the exploratory sample size for cohort 2 at 10 patients.Discussion: The results of this study are expected to provide evidence regarding the usefulness of oral crizotinib for advanced MET exon 14 skipping mutation-positive or MET high gene copy number-positive non-small cell lung cancer.Trial Registration: This study was registered with the University Hospital Medical Information Network Clinical Trials Registry as UMIN000031623 on 3 March 2018. [ABSTRACT FROM AUTHOR] |
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