Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers

Summary

This is a randomized, open-label, multicenter phase III trial of ramucirumab plus paclitaxel, given as switch maintenance, versus continuation of first-line chemotherapy, given as per standard clinical practice, in subjects with unresectable locally advanced or metastatic HER-2 negative gastric or GEJ cancer, without disease progression following 3 months of first-line doublet chemotherapy. The acceptable first-line or lead-in chemotherapy will be: * FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days. * ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days. * XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days.

Timeline

Start

2016-12

Primary completion

2021-12

Completion

2021-12

Publications

• Randon G, Lonardi S, Fassan M, Palermo F, Tamberi S, Giommoni E, Ceccon C, Di Donato S, Fornaro L, Brunetti O, De Vita F, Bittoni A, Chini C, Spallanzani A, Nappo F, Bethaz V, Strippoli A, Latiano T, Cardellino GG, Giuliani F, Morano F, Niger M, Raimondi A, Prisciandaro M, Pircher CC, Sciortino C, Marchesi S, Garattini SK, Airo G, Miceli R, Di Bartolomeo M, Pietrantonio F. Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy in patients with advanced HER2-negative gastric or gastro-oesophageal junction cancer (ARMANI): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Dec;25(12):1539-1550. doi: 10.1016/S1470-2045(24)00580-1. Epub 2024 Nov 15.
• Di Bartolomeo M, Niger M, Morano F, Corallo S, Antista M, Tamberi S, Lonardi S, Di Donato S, Berardi R, Scartozzi M, Cardellino GG, Di Costanzo F, Rimassa L, Luporini AG, Longarini R, Zaniboni A, Bertolini A, Tomasello G, Pinotti G, Scagliotti G, Tortora G, Bonetti A, Spallanzani A, Frassineti GL, Tassinari D, Giuliani F, Cinieri S, Maiello E, Verusio C, Bracarda S, Catalano V, Basso M, Ciuffreda L, De Vita F, Parra HS, Fornaro L, Caporale M, de Braud F, Pietrantonio F. Assessment of Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric or gastroesophageal junction cancers: the ARMANI phase III trial. BMC Cancer. 2019 Mar 29;19(1):283. doi: 10.1186/s12885-019-5498-3.

Drugs

Indications