Lung Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

241

Study ID:

NCT02974725

Recruitment Status:

Terminated

Sponsor:

Novartis Pharmaceuticals

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There are 31 Locations for this study

See Locations Near You

University of California San Diego .
San Diego California, 92103, United States
UCSF Medical Center
San Francisco California, 94143, United States
Massachusetts General Hospital SC
Boston Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Ctr .
New York New York, 10065, United States
Sarah Cannon Research Institute Tennessee Oncology
Nashville Tennessee, 37203, United States
Uni of TX MD Anderson Cancer Cntr
Houston Texas, 77030, United States
Novartis Investigative Site
Westmead New South Wales, 2145, Australia
Novartis Investigative Site
Melbourne Victoria, 3000, Australia
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Lyon , 69373, France
Novartis Investigative Site
Paris 10 , 75475, France
Novartis Investigative Site
Villejuif , 94800, France
Novartis Investigative Site
Dresden , 01307, Germany
Novartis Investigative Site
Essen , 45147, Germany
Novartis Investigative Site
Frankfurt , 60590, Germany
Novartis Investigative Site
Koeln , 50937, Germany
Novartis Investigative Site
Tel Aviv , 64239, Israel
Novartis Investigative Site
Milano MI, 20133, Italy
Novartis Investigative Site
Milano MI, 20162, Italy
Novartis Investigative Site
Rozzano MI, 20089, Italy
Novartis Investigative Site
Verona VR, 37126, Italy
Novartis Investigative Site
Napoli , 80131, Italy
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Seoul , 06351, Korea, Republic of
Novartis Investigative Site
Warszawa , 02 78, Poland
Novartis Investigative Site
Sevilla Andalucia, 41013, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
Pamplona Navarra, 31008, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Stockholm , 171 7, Sweden

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

241

Study ID:

NCT02974725

Recruitment Status:

Terminated

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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