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Neoadjuvant Selpercatinib Under Study in Resectable RET Fusion–Positive NSCLC

By: Sarah Campen, PharmD
Posted: Monday, July 11, 2022

A study examining the efficacy and safety of neoadjuvant selpercatinib in patients with resectable stage IB to IIIA RET fusion–positive non–small cell lung cancer (NSCLC)—Cohort 7 of the LIBRETTO-001 trial—is currently enrolling patients, according to Ravi Rajaram, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues. The details of the single-arm phase II trial of this RET inhibitor were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS8594).

LIBRETTO-001 is an ongoing, global, first-in-human phase I/II trial of selpercatinib in RET fusion–positive advanced or metastatic solid tumors. To be enrolled in this cohort, patients must have histologically confirmed stage IB to IIIA NSCLC, confirmation of RET fusion, a resectable tumor, measurable disease, and an Eastern Cooperative Oncology Group performance status of 0 to 1. Patients with other known oncogenic drivers will be excluded.

Eligible patients will undergo full staging using CT, PET, and MRI of the brain at baseline and after two 28-day cycles of neoadjuvant selpercatinib at 160 mg twice daily, followed by surgery. Based on the treating physician’s decision, patients will receive stage-appropriate adjuvant therapy and/or surveillance followed by selpercatinib until disease recurrence, unacceptable toxicity, withdrawal, or death, for a maximum treatment duration of 3 years.

The study will use Simon’s two-stage design. In stage 1, nine patients will be treated with neoadjuvant selpercatinib; if at least two patients achieve a major pathologic response, defined as up to 10% residual viable tumor cells in the surgically resected specimen, then at least 10 additional patients will be enrolled in stage 2. The safety of perioperative treatment will also be assessed.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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