A Phase Ib, open-label, multicenter study of oral LXH254 in combination with oral LTT462 in adult patients with advanced or metastatic KRAS or BRAF mutant Non-Small Cell Lung Cancer
Adult NSCLC patients, with confirmed diagnosis of advanced or metastatic KRAS- or BRAF V600E-mutant NSCLC who have progressed following standard of care or for whom no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment will be eligible to participate in this study.
To characterize safety and tolerability of LXH254 and LTT462 combination and identify a recommended dose and regimen.
In- and exclusion Criteria
• 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.
• Presence of KRAS or BRAF mutation in tumor tissue prior to study treatment as determined by a local laboratory or a Novartis designated central laboratory, or written documentation of KRAS or BRAF mutation:
- For dose escalation: presence of KRAS or BRAF mutation
- For dose expansion: presence of KRAS mutation for Group 1 and BRAF V600E mutation or BRAF non-V600E mutation for Group 2.
• Dose expansion – Group 1: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. Group 2: Prior treatment with an ERKi and/or a pan-RAFi.
Sponsor Novartis Pharma GmbH
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Klinik I für Innere Medizin/LCGC
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Prof. J. Wolf
Last Update: 10. February 2017