A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma
NCT ID: NCT02974725
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
241 participants
INTERVENTIONAL
2017-02-24
2024-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LXH254+LTT462
LXH254
LXH254 will be supplied as tablet for oral use.
LTT462
LTT462 will be supplied as hard gelatin capsule for oral use.
LXH254+Trametinib
LXH254
LXH254 will be supplied as tablet for oral use.
Trametinib
Trametinib will be supplied as film-coated tablet for oral use
LXH254+Ribociclib
LXH254
LXH254 will be supplied as tablet for oral use.
Ribociclib
Ribociclib will be supplied in tablets and hard gelatin capsules.
Interventions
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LXH254
LXH254 will be supplied as tablet for oral use.
LTT462
LTT462 will be supplied as hard gelatin capsule for oral use.
Trametinib
Trametinib will be supplied as film-coated tablet for oral use
Ribociclib
Ribociclib will be supplied in tablets and hard gelatin capsules.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Napoli, , Italy
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seville, Andalusia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Stockholm, , Sweden
Countries
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References
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Planchard D, Wolf J, Solomon B, Sebastian M, Wermke M, Heist RS, Sun JM, Min Kim T, Reguart N, Sanmamed MF, Felip E, Garrido P, Santoro A, Bootle D, Couillebault XM, Gaur A, Mueller C, Poggio T, Yang J, Moschetta M, Dooms C. A phase Ib study of the combination of naporafenib with rineterkib or trametinib in patients with advanced and metastatic KRAS- or BRAF-mutant non-small cell lung cancer. Lung Cancer. 2024 Nov;197:107964. doi: 10.1016/j.lungcan.2024.107964. Epub 2024 Sep 26.
de Braud F, Dooms C, Heist RS, Lebbe C, Wermke M, Gazzah A, Schadendorf D, Rutkowski P, Wolf J, Ascierto PA, Gil-Bazo I, Kato S, Wolodarski M, McKean M, Munoz Couselo E, Sebastian M, Santoro A, Cooke V, Manganelli L, Wan K, Gaur A, Kim J, Caponigro G, Couillebault XM, Evans H, Campbell CD, Basu S, Moschetta M, Daud A. Initial Evidence for the Efficacy of Naporafenib in Combination With Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase Ib, Open-Label Study. J Clin Oncol. 2023 May 10;41(14):2651-2660. doi: 10.1200/JCO.22.02018. Epub 2023 Mar 22.
Related Links
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Other Identifiers
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2016-004293-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLXH254X2102
Identifier Type: -
Identifier Source: org_study_id
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