Studieoverzicht

Study name: Libretto-432 J2G-MC-JZXZ

Histology	NSCLC, all subtypes
Tumor stage	Stage I - III
Host / recruiting site 1	Radboud UMC	Enrollment	Closed
Therapy line	First line (1L)
Design	Study J2G-MC-JZJX (JZJX) is a randomized, double-blind, Phase 3 study comparing the efficacy and safety of selpercatinib twice daily (BID) to placebo in participants with RET fusion-positive Stage IB-IIIA NSCLC following completion of therapies with a curative intent.
Intervention	Selpercatinib or placebo.
Key inclusion criteria	Histologically confirmed Stage IB, II or IIA NSCLC Activating RET gene fusion in tumor Must have received definitive locoregional therapy with curative intent.
Key exclusion criteria	Additional oncogenic driver mutations SCLC Radiologic evidence of disease recurrence or progression
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