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

NCT04591431 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Fondazione per la Medicina Personalizzata
Phase	Phase 2
Status	UNKNOWN
Enrolment	400
Start date	2020-10-07
Completion	2025-06

Conditions

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

Interventions

• Erlotinib
• Trastuzumab
• Trastuzumab emtansine
• Pertuzumab
• Lapatinib
• Everolimus
• Vemurafenib
• Cobimetinib
• Alectinib
• Brigatinib

Primary outcomes

• OVERALL RESPONSE RATE (ORR) — 42 months
  Evaluation of the ORR of the Treatment at choice of physicians, according to Standard of Care (SoC) or of the Tailored Treatment (TT). The ORR will be constructed according to the specific design of the study, therefore including also the Rescue Therapy Phase data. This means that the ORR will take into account 3 evaluations: * on the original final population ( i.e 384 patients divided into the 4 groups of type of cancer) * on the TT patients, which will include the original randomized TT patients and the patients switched from the standard of care therapy (SoC therapy) to the TT Therapy, this latter within the Rescue Therapy Phase (patients switching upon the first documented progression) * on the population composed by the original TT patients, the original SoC patients and the switched TT patients. This means that the total population analyzed will include the original 384 population data (as per randomization) and the additional switched TT patients.

Countries

Italy