Patologia: Neoplasie del polmone
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
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.
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
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
Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA
Riferimento: Dr. Domenico Galetta
Telefono: 0805555442
Email: galetta@oncologico.bari.it
Numero di iscrizione a registro: 2022-502977-41-00
Data di inserimento: 06.08.2024
ArriVent BioPharma, Inc.
Email: FURMO004CT@arrivent.com
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na