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*

NCT04819100 show modal icon
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.
For information on trial enrollment, locations, and more, call 1-800-545-5979.

or visit www.clinicaltrials.gov for more information on this trial