← Back to Search

Kinase Inhibitor

LXH254 Combination for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have advanced or metastatic NSCLC or cutaneous melanoma
Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (cutaneous melanoma) in tumor tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of a new drug, LXH254, when combined with either LTT462 or trametinib or ribociclib. The goal is to identify a recommended dose and regimen for this new drug combination.

Who is the study for?
This trial is for adults with advanced lung cancer (NSCLC) or skin melanoma that's worsened after standard treatment, or when no suitable standard treatment exists. Participants must have specific mutations in their tumors and be physically able to perform daily activities with some limitations.Check my eligibility
What is being tested?
The study tests the safety and best dose of LXH254 combined with either LTT462, trametinib, or ribociclib. It aims to find out how well patients tolerate these combinations and establish a recommended dosage regimen.See study design
What are the potential side effects?
Potential side effects may include vision problems like retinal vein occlusion, digestive issues due to drug interactions (especially if you can't stop proton pump inhibitors), liver function changes, and general risks associated with anti-cancer medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is advanced non-small cell lung cancer or skin melanoma.
Select...
My cancer has a KRAS, BRAF, or NRAS mutation.
Select...
I can do most of my daily activities on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Dose limiting toxicities (DLTs) (dose escalation only)
Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intentity
+1 more
Secondary outcome measures
Changes from baseline of pharmacodynamics (PD) marker DUSP6 in tumor samples
Derived PK parameter (AUC) for LXH254 & LTT462
Derived PK parameter (AUC) for LXH254 & ribociclib
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: LXH254+TrametinibExperimental Treatment2 Interventions
Group II: LXH254+RibociclibExperimental Treatment2 Interventions
Group III: LXH254+LTT462Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
Ribociclib
2018
Completed Phase 3
~2330

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,112 Total Patients Enrolled

Media Library

LXH254 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02974725 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: LXH254+LTT462, LXH254+Trametinib, LXH254+Ribociclib
Non-Small Cell Lung Cancer Clinical Trial 2023: LXH254 Highlights & Side Effects. Trial Name: NCT02974725 — Phase 1
LXH254 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02974725 — Phase 1

Frequently Asked Questions

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

What are the primary indications for LXH254?

"LXH254 is commonly prescribed to manage malignant neoplasms. However, it may also be useful for postmenopause, metastatic melanoma, and other forms of unresectable melanoma."

Answered by AI

What other research efforts have been made concerning LXH254?

"As of now, 133 clinical research studies dedicated to LXH254 are running, 13 of which have reached Phase 3. Most trials for this medication take place in Portland Oregon but there exist 7114 facilities conducting related experiments."

Answered by AI

Does this groundbreaking clinical trial have any prior analogues?

"Research into the efficacy of LXH254 has been ongoing since 2012, when Pfizer sponsored its inaugural clinical trial. From that initial study involving 189 participants, Phase 1 and 2 approval was eventually granted. Presently there are 133 trials associated with this drug scattered across 53 countries in 1377 cities"

Answered by AI

Are there any vacancies for this trial that participants may apply to fill?

"Per the information located on clinicaltrials.gov, this trial is no longer seeking candidates - it was initially posted in February 2017 and last updated in September 2022. However, presently there are 2811 other clinical trials actively recruiting participants."

Answered by AI

How many participants is this research project looking to recruit?

"This trial has concluded recruitment, having been initially posted on February 24th 2017 and last updated on September 12th 2022. However, for those interested in other related clinical trials there are currently 2678 studies recruiting patients with melanoma and 133 involving LXH254 presently enrolling people."

Answered by AI

Has the drug LXH254 been given authorization by the Food and Drug Administration?

"LXH254's safety has been assessed as a 1 due to the limited clinical data indicating its efficacy and safety, given that this is a Phase 1 trial."

Answered by AI

How widely dispersed are the locations of this experiment?

"This trial is currently running in several sites, including Memorial Sloan Kettering Cancer Center of the state of New york, University of Texas MD Anderson Cancer Center located in Houston and Sarah Cannon Research Institute Tennessee Oncology situated in Nashville."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma
2017. "A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02974725.
~30 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top