J2G-MC-JZJX – LIBRETTO-432 – MULTIHEMO

OC Oncoclínicas Multihemo

Lung

LIBRETTO-432: A double-blind, randomized, placebo-controlled phase 3 study of adjunctive selpercatinib after definitive locoregional treatment in participants with stage IB-IIIA RET positive for NSCLC fusion

Centro

OC Oncoclínicas Multihemo

Investigador principal

Marcelo Salgado

Email

marcelo.salgado@medicos.oncoclinicas.com

Telefone

(81) 3205-0536

Critérios de inclusão

Must have histologically confirmed Stage IB, II, or IIIA NSCLC;
Must have an activating RET gene fusion in the tumor based on polymerase chain reaction (PCR) or next generation sequencing (NGS); Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC;
Must have fully recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Critérios de exclusão

Additional oncogenic drivers in NSCLC, if known;
Evidence of small cell lung cancer;
Clinical or radiological evidence of disease recurrence or progression after definitive therapy;
Known or suspected interstitial fibrosis or interstitial lung disease or history of (non-infectious) pneumonitis requiring steroids;
Clinically significant active cardiovascular disease or history of myocardial infarction in the six months prior to planned initiation of selpercatinib or heart rate-corrected QT interval prolongation using the Fridericia formula (QTcF) greater than 470 milliseconds;
Active uncontrolled systemic, bacterial, viral, or fungal infection or ongoing severe intercurrent illness, such as hypertension or diabetes, despite optimal treatment;
Other malignancy, except non-melanoma skin cancer, carcinoma in situ of the cervix or other cancers in situ, or a malignancy diagnosed greater than or equal to two years ago and not currently active;
Prior treatment with a selective RET inhibitor (eg, selpercatinib or pralsetinib).

Coordenador(es)

José Antonio

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