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-431; NCT04194944

NSCLC

RET Inhibitor


A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib (LOXO-292) to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-small Cell Lung Cancer*

NCT04194944
Key Inclusion Criteria
  • Stage IIIB-IIIC or stage IV nonsquamous non-small cell lung cancer (NSCLC) not suitable for radical surgery or radiation therapy
  • A RET gene fusion in tumor and/or blood from a qualified laboratory, or tumor tissue in sufficient quantity to allow for retrospective central analysis of RET fusion status
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate organ function
  • Patients with reproductive potential must use a highly effective contraceptive method for the duration of treatment and for 6 months after
  • Able to swallow capsules
Key Exclusion Criteria
  • Additional validated oncogenic drivers in NSCLC, if known
  • Previously received systemic therapy for metastatic disease
    • Neoadjuvant/adjuvant chemotherapy is permitted if it was completed at least 12 months prior to randomization
  • Major surgery within 3 weeks prior to planned start of treatment
  • Radiotherapy for palliation within 1 week of the first dose of study treatment or within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung
  • Symptomatic central nervous system metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of treatment
  • Prolongation of the QTcF interval of >470 ms 
  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix, or malignancy diagnosed ≥2 years previously and not currently active
  • Uncontrolled, disease-related pericardial effusion or pleural effusion
  • Receiving pembrolizumab and have a history of interstitial lung disease or interstitial pneumonitis, or have an active autoimmune disease or any illness or treatment that could compromise the immune system
  • Active, uncontrolled systemic bacterial, viral, or fungal infections, or serious ongoing intercurrent illness such as hypertension or diabetes, despite optimal treatment
*
This clinical trial is being conducted globally.
Selpercatinib 160 mg is administered PO BID.
Carboplatin AUC 5 mg∙min/mL is administered intravenously (IV) Q3W.
§
Cisplatin 75 mg/m2 is administered IV Q3W.
Pemetrexed 500 mg/m2 is administered IV Q3W.
Pembrolizumab 200 mg is administered IV Q3W.
#
The co-primary endpoints are PFS in patients receiving pembrolizumab and PFS in all patients.
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.