What side effects are associated with this type of intervention?

Common treatments for NSCLC, including those similar to the LXH254 trial combinations, often involve targeted therapies and immunotherapies. For example, trametinib (a MEK inhibitor) can cause side effects such as rash, diarrhea, and fatigue. Ribociclib (a CDK4/6 inhibitor) is associated with neutropenia, liver enzyme abnormalities, and fatigue. Chemotherapy regimens, such as carboplatin with paclitaxel, can lead to nausea, vomiting, hair loss, and increased risk of infection. Immunotherapies like pembrolizumab may cause immune-related adverse events, including pneumonitis, colitis, and thyroid dysfunction. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

For the treatment of Non-Small Cell Lung Cancer (NSCLC), the FDA has approved several targeted therapies. Sotorasib and adagrasib are approved for patients with KRAS G12C-mutated NSCLC. These drugs target specific genetic mutations similar to how LXH254 targets RAF pathways. Additionally, selpercatinib and pralsetinib are approved for RET fusion-positive NSCLC, and therapies like pembrolizumab are used for PD-L1 expressing tumors. These approvals highlight the trend towards personalized, genotype-directed therapies in NSCLC treatment.

What other types of research exist?

Promising novel alternatives to LXH254 for NSCLC patients include: 1) Alectinib, a second-generation ALK inhibitor, which has shown efficacy in ALK-rearranged NSCLC, especially after ceritinib failure. 2) Entrectinib, a TRK, ROS1, and ALK inhibitor, which has demonstrated significant response rates in NTRK-positive and ALK-rearranged NSCLC. 3) Larotrectinib, another TRK inhibitor, which has shown high response rates in TRK fusion-positive malignancies, including NSCLC. These alternatives offer targeted therapy options based on specific genetic mutations in NSCLC.

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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

Must not have

Patients who have received more than 3 lines of anti-cancer therapy are excluded

Patients with Gilbert's syndrome or other heritable diseases of bile processing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug (LXH254) combined with other existing drugs to find a safe and effective dose for cancer patients who need new treatment options. The drugs work by blocking signals that cancer cells use to grow.

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.

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.

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

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My cancer is advanced non-small cell lung cancer or skin melanoma.

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My cancer has a KRAS, BRAF, or NRAS mutation.

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I can do most of my daily activities on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had 3 or fewer previous cancer treatments.

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I have Gilbert's syndrome or a similar inherited liver condition.

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I have or am at risk for blocked veins in my eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1630

Ribociclib

2018

Completed Phase 3

~2420

0 / 6Eligibility criteria met

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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as EGFR and ALK inhibitors, block specific proteins that promote cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, boost the immune system's ability to detect and kill cancer cells. These treatments are important for NSCLC patients as they provide more personalized and effective options, often leading to improved outcomes and reduced side effects compared to traditional chemotherapy.

A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.Effect of ALK-inhibitors in the treatment of non-small cell lung cancer: a systematic review and meta-analysis.