Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 3  | ENROLLING

LIBRETTO-432; NCT04819100

NSCLC

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
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 (previous systemic anticancer therapy is allowed but not required)
  • 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.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

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.