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.

Conditions

• Gastrointestinal Cancer
• Breast Cancer
• Non Small Cell Lung Cancer
• Other Cancer

Interventions

DRUG

Erlotinib

TT arm

DRUG

Trastuzumab

TT arm

DRUG

Trastuzumab emtansine

TT arm

DRUG

Pertuzumab

TT arm

DRUG

Lapatinib

TT arm

DRUG

Everolimus

TT arm

DRUG

Vemurafenib

TT arm

DRUG

Cobimetinib

TT arm

DRUG

Alectinib

TT arm

DRUG

Brigatinib

TT arm

DRUG

Palbociclib

TT arm

DRUG

Ponatinib

TT arm

DRUG

Vismogedib

TT arm

DRUG

Itacitinib

TT arm

DRUG

Ipatasertib

TT arm

DRUG

Entrectinib

TT arm

DRUG

Atezolizumab

TT arm

DRUG

Nivolumab

TT arm

DRUG

Ipilimumab

TT arm

DRUG

Pemigatinib

TT arm

DRUG

Oncology Drugs

Standard of Care Arm

DRUG

Pralsetinib

TT arm

DRUG

Selpercatinib

TT arm

DRUG

Talazoparib

TT arm

DRUG

Tepotinib

TT arm

DRUG

Alpelisib

TT arm

Sponsors & Collaborators

• Fondazione per la Medicina Personalizzata

  lead OTHER

Principal Investigators

• Paolo Marchetti · Fondazione per la Medicina Personalizzata

• Andrea Botticelli · Università degli Studi di Roma Sapienza

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-07

Primary Completion

2024-12-31

Completion

2025-06-30

Countries

• Italy

Study Locations