J2G-MC-JZJX – LIBRETTO-432

OC Oncoclínicas SP

Lung

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

Center

OC Oncoclínicas SP

Principal investigator

Andrey Soares

Email

andrey.soares@medicos.oncoclinicas.com

Telephone

(11) 3067-5433

Inclusion criteria

Must have histologically confirmed Stage IB, II, or IIIA NSCLC;

Must have a RET activator 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;

Known or suspected interstitial fibrosis or interstitial lung disease or history of pneumonitis (non-infectious) that required steroids;

Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned initiation of selpercatinib or prolongation of the QT interval corrected by heart rate using the Fridericia formula (QTcF) greater than 470 milliseconds;

Uncontrolled active systemic bacterial, viral, or fungal infection or ongoing serious intercurrent disease, such as hypertension or diabetes, despite optimal treatment;

Another 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 earlier and not currently active;

Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).

Coordinator(s)

Mayara Batista
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