Phase 3  | 

LIBRETTO-432; NCT04819100


RET Inhibitor

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*

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Key Inclusion Criteria
  • Stage IB, II, or IIIA non-small cell lung cancer (NSCLC)
  • Activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next-generation sequencing (NGS)
  • Prior definitive locoregional therapy with curative intent (surgery or radiotherapy) for stage IB, II, or IIIA NSCLC
    • Participants must have undergone the available anticancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator’s discretion
  • Complete recovery from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, hepatic, and renal function
  • Patients with reproductive potential must use conventional and highly effective birth control for the duration of the treatment
Key Exclusion Criteria
  • Additional oncogenic drivers in NSCLC, if known
  • Evidence of small cell lung cancer
  • Clinical or radiologic evidence of disease recurrence or progression following definitive therapy
  • Known or suspected interstitial fibrosis or interstitial lung disease, or history of (noninfectious) pneumonitis that required steroids
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 ms
  • Uncontrolled HIV infection or active hepatitis B or C
  • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment
  • Major surgery within 4 weeks prior to planned start of selpercatinib
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix, or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active
  • Pregnancy or lactation
  • Prior treatment with a selective RET inhibitor (eg, selpercatinib or pralsetinib)
This clinical trial is being conducted globally.
Selpercatinib or placebo equivalent is administered PO.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.