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NCT03157128 · ClinicalTrials.gov registry record · Phase 1

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

A Phase 1 study of Non-Small Cell Lung Cancer and Colon Cancer, sponsored by Eli Lilly and Company.

Active
Registry status
Phase 1
Development phase
857
Enrollment target
20
Study locations

NCT03157128: Active Phase 1 study of Non-Small Cell Lung Cancer and Colon Cancer, sponsored by Eli Lilly and Company.

NCT03157128 is a Phase 1 study of Non-Small Cell Lung Cancer and Colon Cancer that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 857 participants, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03157128, a Phase 1 study of Non-Small Cell Lung Cancer and Colon Cancer, is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
857 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Primary Outcome

The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity, excluding * G3 AST, ALT, and/or total bilirubin elevation for \<7 days. * G3 neutropenia \<7 days

Conditions Studied

Non-Small Cell Lung Cancer Colon Cancer Medullary Thyroid Cancer Any Solid Tumor

Interventions

  • DRUG LOXO-292

Study Locations (20)

California

  • City of Hope National Medical Center - Duarte
  • UCLA Medical Center - Los Angeles
  • Hoag Memorial Hospital Presbyterian - Newport Beach
  • Kaiser Permanente - Oakland
  • Irvine Medical Center - Orange
  • University of California - San Diego - San Diego
  • UCSF Medical Center at Mission Bay - San Francisco
  • Kaiser Permanente Medical Center - Walnut Creek

Florida

  • Mayo Clinic in Florida - Jacksonville
  • Memorial Hospital Pembroke - Pembroke

Maryland

  • University of Maryland Medical Center - Baltimore
  • Johns Hopkins University - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Arizona

  • Mayo Clinic of Scottsdale - Scottsdale

Colorado

  • Sarah Cannon Research Institute at HealthOne - Denver

Connecticut

  • Yale Cancer Center - New Haven

Georgia

  • Emory University - Atlanta

Trial Details

FieldValue
Enrollment Target 857 participants
Start Date 2017-05-02
Est. Completion 2027-02
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the registry record for NCT03157128 still lists

NCT03157128 is an interventional study that assigns participants to a tested intervention. The registered 857 participants enrollment target is mid-sized for trials with a published cap, above the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (32% higher).

The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which LOXO-292 is the first listed.

NCT03157128 names 20 study sites across 10 states, led by California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT03157128 about?

NCT03157128 is a clinical study titled "A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)". This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET...

What is the current status of trial NCT03157128?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 857 participants. The study started on 2017-05-02. Estimated completion is 2027-02.

What conditions does trial NCT03157128 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colon Cancer, Medullary Thyroid Cancer, Any Solid Tumor.

What interventions are being tested in trial NCT03157128?

The interventions under investigation include: LOXO-292 (DRUG).

Who is sponsoring clinical trial NCT03157128?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03157128 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03157128's enrollment target sits among peer trials

857 31st of 454 higher than 424 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03157128, the US trial registry maintained by the National Library of Medicine. NCT03157128 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.