Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer

Study summary

The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLDK378 and AUY922

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 19, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: LDK378; Drug: AUY922

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

ALK→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

locally advanced or metastatic NSCLC that has progressed during or following therapy with an ALK inhibitor
tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by FISH
disease that can be evaluated by RECIST v1.1 and measurable disease

Reasons someone may not be able to joinExclusion criteria

central nervous system (CNS) metastases that are symptomatic or require increasing steroids or CNS-directed therapy to control CNS disease
history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
clinically significant cardiac dysfunction
inadequate end organ function as defined by specified laboratory values
use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment
use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment
clinically significant, uncontrolled impaired gastrointestinal function or GI disease
prior treatment with a HSP90 inhibitor
radiotherapy to lung within 4 weeks prior to the first dose of study treatment or patients who have not recovered from radiotherapy-related toxicities
pregnant or nursing women
history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Colorado Dept. of Anschutz Cancer (3)Aurora, Colorado
Massachusetts General Hospital Mass GeneralBoston, Massachusetts
Fox Chase Cancer Center Fox Chase Cancer (2)Philadelphia, Pennsylvania
University of Utah / Huntsman Cancer Institute HuntsmanSalt Lake City, Utah
Novartis Investigative SiteMelbourne, Victoria
Novartis Investigative SiteMilan, MI
Novartis Investigative SiteSingapore
Novartis Investigative SiteBarcelona, Catalonia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2020. Always confirm current availability with the study team.

View original record ↗