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A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations - TAK-788-3001

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
- Documented epithelial growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (United States [US] sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations except EGFR mutations for which there are approved anti-EGFR TKIs (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)
- Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation
- At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1
- Life expectancy ≥3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Criteri di esclusione: 

- Received prior systemic treatment for locally advanced or metastatic disease
- Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities
- Received a moderate or strong cytochrome P-450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before randomization
- Have been diagnosed with another primary malignancy other than NSCLC
- Have current spinal cord compression or leptomeningeal disease
- Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
- Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin.

Trattamento sperimentale: 

TAK-788 Group (Arm A)

Trattamento di controllo: 

Platinum-based Chemotherapy Group (Arm B)

Obiettivi primari dello studio: 

Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST version 1.1 are met or death, whichever occurs first.

Centri partecipanti

Nord Italia

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

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
NB: Arruolamento pazienti non ancora attivo

 

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

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR
NB: Arruolamento pazienti non ancora attivo

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
NB: Arruolamento pazienti non ancora attivo

 

Ospedale S. Maria delle Croci, Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Ospedale Santa Maria delle Croci

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO

 

Centro Italia

AOU Pisana - Cisanello
Via Paradisa 2 - 56124 Pisa - PI
NB: Arruolamento pazienti non ancora attivo

 

Sud Italia e isole

AOU Policlinico Vittorio Emanuele PO G. Rodolico
Via S. Sofia 78 - 95123 Catania - CT
NB: Arruolamento pazienti non ancora attivo

 

Azienda Ospedaliera Vincenzo Monaldi
Via Leonardo Bianchi 1 - 80131 Napoli - NA
NB: Arruolamento pazienti non ancora attivo

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-001845-42

Data di inserimento: 24.11.2020

Promotore

Takeda (Millennium Pharmaceuticals, Inc.)

CRO

/

Principal Investigator ITALIA

Riferimento: Dr. Non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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