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FURMO-004 - A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
- No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
- Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
- Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.

Criteri di esclusione: 

- Inability or unwillingness to swallow pills
- Inability to comply with study and follow-up procedures
- Any other diseases, pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications (e.g., uncontrolled hypertension, active bleeding).

Trattamento sperimentale: 

Furmonertinib.

Trattamento di controllo: 

Platinum-based chemotherapy.

Centri partecipanti

Nord Italia

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Angelo Delmonte
Email: angelo.delmonte@irst.emr.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Oncologia Toracica

Telefono: 0257489482

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
Oncologia Medica ed Ematologia

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

Riferimento: Dr.ssa Alessandra Bearz
Telefono: 0434659294
Email: abearz@cro.it

 

Centro Italia

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
IFO - Istituti Fisioterapici Ospitalieri

Riferimento: Prof. Federico Cappuzzo
Email: federico.cappuzzo@ifo.it

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

Riferimento: Dr. Domenico Galetta
Telefono: 0805555442
Email: galetta@oncologico.bari.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-502977-41-00

Data di inserimento: 06.08.2024

Promotore

ArriVent BioPharma, Inc.

Email: FURMO004CT@arrivent.com

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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