LOXO-260 for Non-Small Cell Lung Cancer

Recruiting at 16 trial locations

Overseen By Patient Advocacy

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: CYP3A inhibitors/inducers

Disqualifiers: Infections, CNS malignancy, serious conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing LOXO-260, a new drug for treating cancers with a specific genetic change in the RET gene. 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 (LOXO-292), a predecessor to LOXO-260, has shown marked and durable antitumor activity in patients with RET-altered tumors.

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.

What makes the drug LOXO-260 unique for treating non-small cell lung cancer?

LOXO-260 is a novel treatment option for non-small cell lung cancer, potentially offering a targeted approach that differs from traditional chemotherapy, which often involves platinum-based drugs. While standard treatments focus on broad-spectrum chemotherapy, LOXO-260 may provide a more specific mechanism of action, potentially leading to fewer side effects and improved outcomes for patients. ^{1 2 3 4 5}

Research Team

Emin Avsar

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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

My organs are functioning well.

I have been treated with a RET inhibitor before.

I am at least 18 years old, or 12 and older in certain locations.

Exclusion Criteria

I am not taking medication that strongly affects liver enzyme CYP3A.

My cancer worsened within 4 months after starting a RET inhibitor treatment.

My cancer has specific genetic changes making it resistant to certain treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1A: Dose Escalation

LOXO-260 administered orally to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)

4 weeks

Multiple visits for dose escalation monitoring

Treatment Phase 1B: Dose Expansion

LOXO-260 administered orally to assess antitumor activity and overall response rate (ORR)

Up to 24 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Phase 1B: LOXO-260 Dose Expansion Experimental Treatment 1 Intervention

LOXO-260 administered orally

Group II: Phase 1A: LOXO-260 Dose Escalation Experimental Treatment 1 Intervention

LOXO-260 administered orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

Trials

72

Recruited

11,600+

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy in metastatic and locally advanced non-small cell lung cancer. [2006]

2. France pubmed.ncbi.nlm.nih.gov

[Neo-adjuvant chemotherapy of locally advanced non-small cell bronchial cancers]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Phase I/II trial of a COX-2 inhibitor with limited field radiation for intermediate prognosis patients who have locally advanced non-small-cell lung cancer: radiation therapy oncology group 0213. [2018]

4. Cyprus pubmed.ncbi.nlm.nih.gov

Doxorubicin loaded liposomes for lung tumor targeting: in vivo cell line study in human lung cancer. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Anthracyclines in non-small cell lung cancer. [2019]