LOXO-260 for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called LOXO-260 to evaluate its safety and effectiveness for non-small cell lung cancer. The treatment targets cancers with changes in the RET gene, which can influence cancer cell growth. Suitable candidates for this trial include those who have previously tried a RET inhibitor and have cancer that cannot be removed or has spread. Participants will take LOXO-260 orally and may remain in the study for up to two years or longer if their condition stays stable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you must have stopped all previous cancer treatments and resolved any significant side effects before joining. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that LOXO-260 is likely to be safe for humans?
Research shows that LOXO-260 is a promising new treatment under testing for non-small cell lung cancer. It targets changes in the RET gene, potentially fighting the cancer more effectively.
Earlier studies have demonstrated that LOXO-260 acts as a strong and precise inhibitor, blocking only necessary targets without significantly affecting other parts of the body. This study is in its early phase, focusing on safety, and marks the first time LOXO-260 is tested in humans. Researchers are still assessing its tolerability and potential side effects.
Limited human data is available, so information on safety is still being gathered. Participants in the trial will help researchers learn more about the safety of LOXO-260 for individuals with this gene change.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for non-small cell lung cancer, which typically involve chemotherapy, targeted therapy, or immunotherapy, LOXO-260 acts on a specific target. LOXO-260 is unique because it is designed to inhibit a particular enzyme that plays a critical role in the growth and survival of cancer cells. Researchers are excited about this drug because it offers the potential for a more precise attack on cancer cells, possibly leading to fewer side effects and improved outcomes compared to traditional treatments. Additionally, LOXO-260 is administered orally, which can be more convenient and less invasive for patients than other treatments that require infusions or injections.
What evidence suggests that LOXO-260 might be an effective treatment for non-small cell lung cancer?
Research has shown that LOXO-260 is a promising treatment for non-small cell lung cancer (NSCLC) with a change in the RET gene. LOXO-260 targets and blocks cancer growth. In studies, 51% of patients experienced a complete or partial response, with significant tumor shrinkage. The cancer did not worsen for an average of 7.8 months. The trial will evaluate LOXO-260 in two phases: Phase 1A will focus on dose escalation, and Phase 1B will focus on dose expansion. This suggests that LOXO-260 could slow the disease and improve outcomes for patients with this specific genetic change.23467
Who Is on the Research Team?
Emin Avsar
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1A: Dose Escalation
LOXO-260 administered orally to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Treatment Phase 1B: Dose Expansion
LOXO-260 administered orally to assess antitumor activity and overall response rate (ORR)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LOXO-260
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
LOXO-260 administered orally
LOXO-260 administered orally
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Loxo Oncology, Inc.
Industry Sponsor
Jacob Van Naarden
Loxo Oncology, Inc.
Chief Executive Officer since 2019
A.B. in Molecular Biology from Princeton University
Dr. Jennifer Low
Loxo Oncology, Inc.
Chief Medical Officer since 2014
MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology
Citations
NCT05241834 | A Study of LOXO-260 in Cancer Patients ...
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a ...
A first-in-human phase 1 study of the next-generation RET ...
LOXO-260 is a highly potent and selective inhibitor of RET designed to have activity against both solvent front and gatekeeper mutations.
LOXO-260 for Non-Small Cell Lung Cancer
The drug aims to block this gene to stop cancer cells from growing. The study will check if the drug is safe and effective over a period of time. Selpercatinib ...
Treatment of non–small cell lung cancer with RET ...
Of the 65 evaluable patients, 51% (33 of 65) achieved a complete or partial response, with an mPFS of 7.8 months and median overall survival ( ...
LOXO-260 / Eli Lilly
Clinical • P1 data • Endocrine Cancer • Lung Cancer • Non Small Cell Lung ... Improving Outcomes for Patients With NSCLC and RET Alterations (Targeted ...
Expanded Access for LOXO-260 in Participants With ...
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...
A first-in-human phase 1 study of the next-generation RET ...
LOXO-260 is a highly potent and selective inhibitor of RET designed to have activity against both solvent front and gatekeeper mutations, expressed alone or ...
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