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 2  | ENROLLING

LIBRETTO-001; NCT03157128

NSCLC, Medullary Thyroid Cancer, Papillary Thyroid Carcinoma, or Other Advanced Solid Tumors

RET Inhibitor

A Phase 1/2 Study of Oral Selpercatinib in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation*

Key Inclusion Criteria
  • Locally advanced or metastatic solid tumor that progressed following standard therapy, or for which no standard therapy exists
  • Patients who decline standard therapy for their tumor type and stage or who, in the opinion of the investigator, would not tolerate and/or benefit from standard therapy
  • During phase 1, once a safe dose level consistent with inhibiting RET is achieved, patients must have advanced non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), or other advanced solid tumor with evidence of prior RET alteration or other evidence of increased RET activity in tumor tissue and/or blood
  • For MTC: Progressive disease within the previous 14 months as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • At least one measurable lesion as defined by RECIST 1.1 or Response Assessment in Neuro-Oncology Criteria (RANO), as appropriate to tumor type, not previously irradiated, and not chosen for biopsy during the screening period. Patients without RECIST 1.1 or RANO measurable disease may be eligible for enrollment to group 5
  • Any number of prior multikinase inhibitors
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate hematologic, hepatic, and renal function
  • Life expectancy of at least 3 months
Key Exclusion Criteria
  • For NSCLC patients: A targetable mutation in EGFR or targetable rearrangement involving ALK or ROS1
  • Prior treatment with a selective RET inhibitor(s), including investigational selective RET inhibitor(s)
  • Investigational agent or anticancer therapy within 5 half-lives or 2 weeks (14 days) prior to planned start of selpercatinib
  • Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of selpercatinib
  • Radiotherapy with a limited field of radiation for palliation within 1 week of planned start of selpercatinib, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment
  • Symptomatic primary central nervous system (CNS) tumor or metastases (stable CNS tumor/metastases is allowed)
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QTc interval of >470 ms
  • Required treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers
This clinical trial is being conducted globally.
Selpercatinib 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.