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: 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

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-001979-36

Data di inserimento: 24.04.2020

Data di aggiornamento: 26.06.2020

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)