Patologia: Neoplasie del polmone
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Richiesta mandatoria di tessuto: Sì
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
Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Oncologia Medica
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
Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
Oncologia Medica
Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Dipartimento di Onco-ematologia. NB Arruolamento pazienti non ancora attivo
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
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
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Oncologia Medica
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
Numero di iscrizione a registro: 2019-001979-36
Data di inserimento: 24.04.2020
Data di aggiornamento: 18.12.2020
Eli Lilly and Company
IQVIA
AOU San Luigi Gonzaga - Orbassano (TO)
Riferimento: Prof.ssa Silvia Novello
Telefono: 0119026978
Email: silvia.novello@unito.it
Localita: Orbassano (TO)