J2G-MC-JZJX – LIBRETTO-432 – COT Uberlândia

OC Oncoclínicas COT Uberlândia

Lung

LIBRETTO-432: A phase 3 randomized double-blind placebo-controlled trial of adjuvant selpercatinib after definitive locoregional treatment in NSCLC fusion-positive stage IB-IIIA RET participants

Center

OC Oncoclínicas COT Uberlândia

Principal investigator

Fernando Maciel

Email

pesquisaclinicaudi@oncoclinicas.com

Telephone

(34) 99832-3218 e (34) 3291-3542

Inclusion criteria

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 radiation therapy) for Stage IB, II, or IIIA NSCLC;
Must have fully recovered from definitive therapy (surgery or radiation therapy) as well as adjuvant therapy at the time of randomization;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion criteria

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;
Interstitial fibrosis or known or suspected interstitial lung disease or history of pneumonitis (non-infectious) that required steroids;
Clinically significant active cardiovascular disease or a history of myocardial infarction within the six months prior to the planned initiation of selpercatinib or a heart rate-corrected QT interval prolongation using Fridericia’s formula (QTcF) greater than 470 milliseconds;
Uncontrolled systemic, active bacterial, viral or fungal infection or ongoing serious intercurrent illness such as hypertension or diabetes despite optimal treatment;
Other malignancy, other than non-melanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers, or a malignancy diagnosed greater than or equal to two years earlier and not currently active;
Prior treatment with a selective RET inhibitor (eg, selpercatinib or pralsetinib).

Coordinator(s)

Marcella Nogueira
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