for people ages 18 years and up (full criteria)
study started
estimated completion
Principal Investigator
by Shumei Kato (ucsd)Adil Daud (ucsf)
Photo of Shumei Kato
Shumei Kato
Photo of Adil Daud
Adil Daud



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

Official Title

A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma


Non-Small Cell Lung Cancer Melanoma NSCLC NRAS KRAS BRAF LXH254 LTT462 Trametinib Ribocliclib Non-small cell lung carcinoma (NSCLC) treatment of lung cancer after first metastasis lung cancer lung adenocarcinoma Large-cell lung carcinoma Non small cell lung carcinoma Non small cell lung cancer Large cell lung carcinoma Large cell lung cancer squamous cell lung carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Ribociclib LXH254+LTT462 LXH254+Trametinib LXH254+Ribociclib


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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


  • University of California San Diego accepting new patients
    San Diego California 92103 United States
  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States

Lead Scientists at UC Cancer

  • Shumei Kato (ucsd)
    Associate Clinical Professor, Medicine. Authored (or co-authored) 86 research publications.
  • Adil Daud (ucsf)
    Professor, Medicine. Authored (or co-authored) 184 research publications.


accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 1
Study Type
Last Updated