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

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

ClinicalTrials.gov Identifier: NCT02974725

Novartis Reference Number: CLXH254X2102

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Non-Small Cell Lung Cancer
Melanoma
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
315 participants
Start date 
Feb 24, 2017
Completion date 
Jan 11, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LXH254
LXH254 will be supplied as tablet for oral use.
Drug
LTT462
LTT462 will be supplied as hard gelatin capsule for oral use.
Drug
Trametinib
Trametinib will be supplied as film-coated tablet for oral use
Drug
LXH254
Trametinib will be supplied as film-coated tablet for oral use
Drug
Ribociclib
Ribociclib will be supplied in tablets and hard gelatin capsules.

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. BRAF mutant patients group: Prior treatment with an ERKi and/or a pan-RAFi.
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 Locations

United States
University of California San Diego
Recruiting
San Diego, 92103
California
United States
UCSF Medical Center
Recruiting
San Francisco, 94143
California
United States
Massachusetts General Hospital SC
Recruiting
Boston, 02114
Massachusetts
United States
Sarah Cannon Research Institute Tennessee Oncology
Recruiting
Nashville, 37203
Tennessee
United States
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Novartis Investigative Site
Recruiting
Prahran, 3181
Victoria
Australia
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
-
France
Novartis Investigative Site
Recruiting
Villejuif Cedex, 94800
-
France
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06351
-
Korea, Republic of
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02 781
-
Poland
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain
Sweden
Novartis Investigative Site
Recruiting
Stockholm, 171 76
-
Sweden

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]