LIBRETTO-432 — Adjuvant Selpercatinib Versus Placebo in Resected Stage IB–IIIA RET Fusion–Positive Non–Small Cell Lung Cancer

Phase 3 · 2026 · Non-Small Cell Lung Cancer

Design

Randomized, double-blind, placebo-controlled phase 3 trial (n=151) of adjuvant selpercatinib (160 mg BID; 120 mg BID if <50 kg) versus placebo for up to 3 years after curative-intent surgery or radiotherapy (± adjuvant chemotherapy); crossover to selpercatinib allowed at recurrence.

Population

Resected stage IB–IIIA RET fusion-positive NSCLC; primary event-free survival analysis in the stage II–IIIA population (n=109).

Primary Endpoint

investigator-assessed event-free survival (EFS)

Key Result

In the stage II–IIIA primary population, an ~83% reduction in the risk of disease recurrence or death (HR 0.172; P=0.0003); median EFS not reached with selpercatinib vs 31.8 months with placebo; 24-month EFS 91.5% vs 61.1%.

Guideline Impact

Supports adjuvant selpercatinib as a new standard for resected RET fusion-positive stage II–IIIA NSCLC