The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Summary

This is a randomized, prospective, multicenter, Proof of Concept, Phase II clinical trial Study. The main objective of the study is to evaluate the efficacy (meant as overall response rate ORR) of TT (targeted Therapy) vs SoC (standard of Care) in patients with progressive disease (recurrent and/or metastatic) of breast cancer, metastatic gastro-intestinal tumors, non small cell lung cancer (NSCLC) or others. Patients should have completed at least 1 line of treatment and no more than 2 as defined by the current version of the AIOM (Italian Association of Medical Oncology) guidelines. Patients are included if surgery is contraindicated.

Timeline

Start

2020-10-07

Primary completion

2024-12

Completion

2025-06

Outcome

Met primary endpoint

paper TT achieved a significantly higher ORR (17.5% versus 10%; P = 0.0294) PMID 41023484 ↗

Publications

• Marchetti P, Curigliano G, Westphalen CB, Biffoni M, Lonardi S, Scagnoli S, Fornaro L, Guarneri V, De Giorgi U, Ascierto PA, Blandino G, D'Amati G, Aglietta M, Cremolini C, Conte P, Crimini E, Ceracchi M, Pisegna S, Verkhovskaia S, Bordonaro R, Bracarda S, Butturini G, Del Mastro L, DeCensi A, Fabbri A, De Galitiis F, Fenocchio E, Gori S, Metro G, Pessino A, Pozzessere D, Puglisi F, Tamberi S, Zambelli A, Marino D, Capoluongo E, Cappuzzo F, Cerbelli B, Giannini G, Malapelle U, Mazzuca F, Nuti M, Pruneri G, Simmaco M, Strigari L, Tonini G, Savarese A, Adamo V, Quaresmini D, Tagliaferri P, Damiano P, Urbini B, Bengala C, Zaffignani E, Pinto C, Tosoni A, Buffoni L, Maiello E, Mucciarini C, Russo A, Berardi R, Lombardi G, Piancastelli A, Masi G, Bonanno L, Vanella V, Mannozzi F, Martini N, Botticelli A. The role of the molecular tumor board: learnings from the ROME trial. NPJ Precis Oncol. 2026 Apr 10;10(1):213. doi: 10.1038/s41698-026-01386-1.
• Marchetti P, Curigliano G, Biffoni M, Lonardi S, Scagnoli S, Fornaro L, Guarneri V, De Giorgi U, Ascierto PA, Blandino G, D'Amati G, Aglietta M, Cremolini C, Conte P, Crimini E, Ceracchi M, Pisegna S, Verkhovskaia S, Bordonaro R, Bracarda S, Butturini G, Del Mastro L, DeCensi A, Fabbri A, Fenocchio E, Gori S, Metro G, Pessino A, Pozzessere D, Puglisi F, Tamberi S, Zambelli A, Marino D, Capoluongo E, Cappuzzo F, Cerbelli B, Giannini G, Malapelle U, Mazzuca F, Nuti M, Pruneri G, Simmaco M, Strigari L, Tonini G, Martini N, Botticelli A; ROME trial investigators consortia. Genomically matched therapy in advanced solid tumors: the randomized phase 2 ROME trial. Nat Med. 2025 Oct;31(10):3514-3523. doi: 10.1038/s41591-025-03918-x. Epub 2025 Sep 29.

Drugs

Indications