A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

Stopped early · Phase 1

Conditions studied: Non-Small Cell Lung Cancer, Melanoma

In brief

To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.

Key facts

Study ID

NCT02974725

Run by

Novartis Pharmaceuticals

People needed

241

Starts

2017-02-24

Expected to finish

2024-04-24

Last updated by the study team

2025-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
• ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

You may not qualify if…

• Dose expansion - KRAS or NRAS mutant patients groups: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. (Patients with KRAS mutant NSCLC with prior G12C inhibitor treatments are also excluded in the LXH254+trametinib expansion part). BRAF mutant patients group: Prior treatment with any EGFR, ALK, ROS1, KRAS, RAF (both BRAFV600 selective and pan-RAF), MEK1/2 and/or ERK1/2 inhibitors (for patients with BRAF V600 mutant NSCLC, prior treatments with BRAF and MEK1/2 inhibitors are allowed).
• Patients who have received more than 3 lines of anti-cancer therapy are excluded.
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
• Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
• Patients with Gilbert's syndrome or other heritable diseases of bile processing.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of California San Diego . — San Diego, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Massachusetts General Hospital SC — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Ctr . — New York, New York, United States
• Sarah Cannon Research Institute Tennessee Oncology — Nashville, Tennessee, United States
• Uni of TX MD Anderson Cancer Cntr — Houston, Texas, United States
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Cologne, Germany
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Tel Aviv, Israel
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Verona, VR, Italy
• Novartis Investigative Site — Naples, Italy
• Novartis Investigative Site — Warsaw, Poland
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Seoul, South Korea

Full record on ClinicalTrials.gov

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