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Kinase Inhibitor

LOXO-260 for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have received a prior selective RET inhibitor.
Have discontinued all previous treatments for cancer with resolution of any significant AEs, and of all clinically significant toxic effects of prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months or 2 years
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of a new drug, LOXO-260, for treating cancer with a specific genetic mutation. The trial will last up to 2 years, and participants may continue longer if their disease does not worsen.

Who is the study for?
This trial is for adults with non-small cell lung or thyroid cancer linked to a specific gene change (RET) who've tried other treatments without success. They should be in good physical condition, have had no recent disease progression, and their organs must function well. Children over 12 may join in some cases.Check my eligibility
What is being tested?
LOXO-260 is being tested for safety and effectiveness on cancers with the RET gene alteration. Participants will receive LOXO-260 for up to two years or longer if beneficial, monitoring how it affects their cancer's progression.See study design
What are the potential side effects?
While not explicitly listed here, side effects of LOXO-260 could include typical reactions seen with cancer therapies such as fatigue, nausea, liver issues, blood count changes or allergic reactions; specifics would emerge from the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been treated with a RET inhibitor before.
Select...
I have stopped all cancer treatments and recovered from major side effects.
Select...
My cancer is advanced and cannot be removed by surgery, and it has a RET fusion or mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months or 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months or 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
Secondary outcome measures
Phase 1b: To assess the antitumor activity: Overall response rate (ORR)
To assess the antitumor activity of LOXO-260: ORR
To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 1B: LOXO-260 Dose ExpansionExperimental Treatment1 Intervention
LOXO-260 administered orally
Group II: Phase 1A: LOXO-260 Dose EscalationExperimental Treatment1 Intervention
LOXO-260 administered orally

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,612 Previous Clinical Trials
3,200,797 Total Patients Enrolled
Loxo Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
9,759 Total Patients Enrolled
Emin AvsarStudy DirectorLoxo Oncology, Inc.

Media Library

LOXO-260 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05241834 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Phase 1A: LOXO-260 Dose Escalation, Phase 1B: LOXO-260 Dose Expansion
Non-Small Cell Lung Cancer Clinical Trial 2023: LOXO-260 Highlights & Side Effects. Trial Name: NCT05241834 — Phase 1
LOXO-260 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241834 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple facilities within the Canadian borders running this experiment?

"Currently, 11 recruitment sites are available for this project located in Atlanta, Boston and Chicago plus 8 additional cities. To minimize your travel needs if you choose to participate, please select the nearest site from your location."

Answered by AI

Are there vacancies available for individuals to participate in this clinical study?

"The clinical trial page on clinicialtrials.gov confirms that the this research endeavour is actively seeking participants, having first been posted in March of 2022 and updated as recently as November 11th."

Answered by AI

How extensive is the participant pool in this investigation?

"This medical study necessitates the recruitment of 140 eligible patients. Those hoping to take part can go to either Emory University in Atlanta, Georgia or Dana-Farber Cancer Institute in Boston, Massachusetts."

Answered by AI

Has the Food and Drug Administration sanctioned the use of LOXO-260?

"Since only minimal safety and efficacy information exists for LOXO-260, our team at Power gave it a score of 1 on the risk scale."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

the drug i am on is losing efficacy.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment
2022. "A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05241834.
All > Non Small Cell Lung Cancer
~38 spots leftby Jun 2025
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