TerminatedPhase 1

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

Stopped: Business reasons

United States241 participantsStarted 2017-02-24

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Number of participants with Adverse Events (AEs) as a measure of safety and tolerability

Timeframe: up to 5 years

Dose limiting toxicities (DLTs) (dose escalation only)

Timeframe: up to 3 years

Tolerability measured by the number of subjects who have interruptions/reductions of study treatment and reason for interruptions/reductions

Timeframe: up to 5 years

Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intentity

Timeframe: Up to 5 years

Trial details

NCT IDNCT02974725

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-24

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