Clinical Trial

A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC (LIBRETTO-432) (J2G-MC-JZJX)

Brief Summary: The purpose of this study is to see if the study drug, Selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to Selpercatinib. Participation could last up to three years.

Key Eligibility Criteria:

• Must have histologically confirmed Stage IB, II, or IIIA NSCLC
• Must have an activating RET gene fusion in tumor 
• Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC
  • Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator’s discretion
• Additional oncogenic drivers in NSCLC, if known excluded
• Evidence of small cell lung cancer excluded
• Clinical or radiologic evidence of disease recurrence or progression following definitive therapy excluded