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
Outcome
Met primary endpoint
paper Median progression-free survival was 6·6 months (95% CI 5·9-7·8) in the switch maintenance group and 3·5 months (2·8-4·2) in the control group PMID 39557058 ↗
paper (HR 0·61, 95% CI 0·48-0·79; p=0·0002). PMID 39557058 ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 2000 mg/m2 | — |
| Comparator | L-LEUCOVORIN | Unknown | 100 mg/m2 | — |
| Comparator | L-LEUCOVORIN | Unknown | 200 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Ramucirumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 600 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | — |