Ramucirumab Plus TAS-102 in Patients With Advanced or Metastatic Gastric Adenocarcinoma or the Gastroesophageal Junction

Summary

The objective of this study is to determine whether a combination of ramucirumab, beyond progression after a SOC 2nd line ramucirumab based pre-treatment (Ram beyond progression) in patients with locally advanced or metastatic adenocarcinoma, plus TAS-102 shows good tolerability without safety issues regarding the serious adverse event rate of any cause, and whether the combination shows positive signals regarding efficacy in the secondary endpoints (e.g. prolongation of progression-free survival of TAS-102 plus ramucirumab compared with TAS-102 monotherapy - historical data according to TAGS trial).

Timeline

Start

2020-10-15

Primary completion

2022-01-13

Completion

2023-01-20

Publications

• Goetze TO, Stein A, Lorenzen S, Habibzada T, Goekkurt E, Herhaus P, Loose M, Sookthai D, Brulin T, Ihrig K, Pauligk C, Al-Batran SE. Ramucirumab beyond progression plus TAS-102 in patients with advanced or metastatic esophagogastric adenocarcinoma, after treatment failure on a ramucirumab-based therapy. Int J Cancer. 2023 Nov 15;153(10):1726-1733. doi: 10.1002/ijc.34652. Epub 2023 Jul 16.

Drugs

Indications