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Tyrosine Kinase Inhibitor

Selpercatinib for Solid Tumors (LIBRETTO-001 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a histologically confirmed stage IB-IIIA NSCLC and a RET fusion; determined to be medically operable and tumor deemed resectable by a thoracic surgical oncologist, without prior systemic treatment for NSCLC
Cohorts 1-4 without measurable disease
Must not have
Major surgery (excluding placement of vascular access) within 2 weeks prior to planned start of LOXO-292 (selpercatinib)
Required treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and certain prohibited concomitant medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the first 28 days of treatment (cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the participant discontinues from the study)
Awards & highlights

Summary

This trial is testing a new oral drug called selpercatinib in patients with advanced cancers that have specific gene changes. The drug aims to block a gene that helps cancer grow, potentially slowing or stopping the disease.

Who is the study for?
This trial is for people with advanced solid tumors, RET fusion-positive solid tumors, or medullary thyroid cancer who have tried standard treatments without success or can't tolerate them. They must have a life expectancy of at least 3 months and good organ function. People with certain genetic alterations may join only after Sponsor approval. Those who've had recent major surgery, other cancer therapies, or untreated brain metastases are excluded.
What is being tested?
The study tests Selpercatinib (LOXO-292), an oral medication targeting specific genetic changes in tumors. It's given to participants with various types of advanced cancers to assess its safety and how well it works against these cancers.
What are the potential side effects?
While the exact side effects aren't listed here, common ones for drugs like Selpercatinib include fatigue, nausea, liver issues, high blood pressure, dry mouth/skin problems and potential heart rhythm abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is in an early stage, operable, and has not been treated yet.
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My cancer cannot be measured by standard tests.
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My tumor has a RET gene alteration.
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I have at least one tumor that can be measured and hasn't been treated with radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 2 weeks.
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I am not taking strong drugs that affect liver enzymes or forbidden medications.
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I haven't had a heart attack in the last 6 months and my heart's electrical cycle is normal.
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I have not had any systemic therapy for my lung cancer.
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I have previously been treated with a RET inhibitor.
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I haven't taken any experimental cancer treatments recently.
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My cancer has a known genetic mutation driving its growth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the first 28 days of treatment (cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the participant discontinues from the study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and the first 28 days of treatment (cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the participant discontinues from the study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: MTD
Phase 1: RP2D
Phase 2: Objective Response Rate
Secondary study objectives
Phase 1 and 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib)
Phase 1 and 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib)
Phase 1: Number of Participants with a Treatment-Related Adverse Event(s) (TRAE[s])
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: LOXO-292Experimental Treatment1 Intervention
Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve targeted therapies that inhibit specific molecular pathways critical for tumor growth and survival. For instance, Selpercatinib is a RET inhibitor that targets RET fusion-positive tumors by blocking the RET kinase activity, thereby inhibiting tumor cell proliferation and survival. Similarly, other targeted therapies include EGFR inhibitors (e.g., osimertinib, erlotinib) that block the epidermal growth factor receptor, and ALK inhibitors (e.g., crizotinib) that target the anaplastic lymphoma kinase. These treatments are crucial for NSCLC patients as they offer a more personalized approach, leading to better efficacy and potentially fewer side effects compared to traditional chemotherapy. By targeting specific genetic mutations or alterations, these therapies can significantly improve outcomes and quality of life for patients with advanced NSCLC.
Tailoring tyrosine kinase inhibitors to fit the lung cancer genome.

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
10,204 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,653 Previous Clinical Trials
3,223,649 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,376 Previous Clinical Trials
422,253 Total Patients Enrolled

Media Library

LOXO-292 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03157128 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: LOXO-292
Non-Small Cell Lung Cancer Clinical Trial 2023: LOXO-292 Highlights & Side Effects. Trial Name: NCT03157128 — Phase 1 & 2
LOXO-292 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03157128 — Phase 1 & 2
~38 spots leftby Feb 2025