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A Multicenter, Randomized, Open-Label, Phase 3 Trial comparing LOXO-292 to Platinum-Based and Pemetrexed Therapy with or without Pembrolizumab as initial treatment of advanced or metastatic RET fusion-positive NSCLC treatment - J2G-MC-JZJC

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 confirmed Stage IIIB-IIIC or Stage IV NSCLC that is not suitable for radical surgery or radiation therapy (Lim et al. 2018). The histology of the tumor must be predominantly non-squamous. Squamous cell and/or mixed small cell/non-small cell histology is not permitted.
- Must have a RET gene fusion in tumor using PCR or NGS or blood using NGS.
- The RET gene fusion result should be generated from a laboratory with CLIA, ISO/EIC, CAP, or other similar certification that clearly denotes the presence of a RET alteration. Blood results must be determined on a Lilly-approved platform.
- have measurable disease per RECIST 1.1 (Eisenhauer et al. 2009) as assessed by the investigator. Target lesions situated in a previously irradiated area are considered measurable if progression has been determined in such lesions, and the location of previously irradiated lesions is clearly documented.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 (Oken et al. 1982)
- Must have life expectancy of at least 3 months.

Criteri di esclusione: 

- Additional validated oncogenic drivers in NSCLC if known.
- Prior systemic therapy for metastatic disease. Chemotherapy in the adjuvant/neoadjuvant setting is permitted if it was completed at least 12 months prior to randomization.
- Major surgery within 3 weeks prior to planned start of selpercatinib.
- Radiotherapy for palliation within 1 week of the first dose of study treatment or within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung.
- Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
- Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 milliseconds.
- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
- Pregnancy or lactation.
- Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or malignancy diagnosed ≥2 years previously and not currently active.
- Symptomatic ascites or pleural effusion
- Requiring chronic treatment with steroids.


Exclusion Criteria for Participants Receiving Pembrolizumab:
- History of interstitial lung disease or interstitial pneumonitis.
- Active autoimmune disease or any illness or treatment that could compromise the immune system.

Trattamento sperimentale: 

Loxo 292+pembrolizumab

Trattamento di controllo: 

Pemetrexed/Platinum+pembrolizumab

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Oncologia Medica - NB: L'arruolamento dei pazienti non è ancora attivo

 

Ospedale Niguarda Ca' Granda
Piazza dell'Ospedale Maggiore 3 - 20162 Milano - MI
Oncologia

Riferimento: Prof. Salvatore Siena
Telefono: 800638638
Email: oncologia@ospedaleniguarda.it

 

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

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB
UO Oncologia - NB: L'arruolamento dei pazienti non è ancora attivo

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
Oncologia Medica - NB: L'arruolamento dei pazienti non è ancora attivo

 

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Dipartimento di Onco-ematologia

Riferimento: Prof. Federico Cappuzzo
Telefono: 0544285206
Email: federico.cappuzzo@auslromagna.it

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO
Unità di Oncologia Polmonare

Riferimento: Prof.ssa Silvia Novello
Telefono: 0119026978
Email: silvia.novello@unito.it

 

Centro Italia

AOU Pisana - Cisanello
Via Paradisa 2 - 56124 Pisa - PI
UO Pneumologia

 

Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM
Oncologia Medica - Padiglione Flaiani - NB: L'arruolamento dei pazienti non è ancora attivo

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Oncologia Medica

 

Sud Italia e isole

A.O.S.G. Moscati
Contrada Amoretta - 83100 Avellino - AV
Oncologia Medica

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
Oncologia Medica

Riferimento: Alessandro Morabito
Telefono: 0815903631
Email: a.morabito@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-001979-36

Data di inserimento: 24.04.2020

Data di aggiornamento: 31.07.2020

Promotore

Eli Lilly and Company

CRO

IQVIA

Principal Investigator ITALIA

AOU San Luigi Gonzaga - Orbassano (TO)

Riferimento: Prof.ssa Silvia Novello

Telefono: 0119026978

Email: silvia.novello@unito.it

Localita: Orbassano (TO)

 

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