AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients

Study summary

The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAZD6244 and docetaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 20, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?63 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: AstraZeneca
Interventions being studied: Drug: AZD6244; Drug: docetaxel; Drug: Placebo

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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)→

Disease setting

Locally advanced→Metastatic or stage IV→

Biomarkers

KRAS→

Treatment approach

Chemotherapy→

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 non small cell lung cancer (IIIB-IV)
Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21).

Reasons someone may not be able to joinExclusion criteria

Received \>1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy)
Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable)
Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month

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

Research SiteLos Angeles, California
Research SiteAurora, Colorado
Research SiteBoston, Massachusetts
Research SiteColumbus, Ohio
Research SiteBrussels
Research SiteCharleroi
Research SiteEdegem
Research SiteLeuven
Research SiteLiège
Research SiteLiège
Research SiteBelo Horizonte
Research SiteIjuí

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 20, 2018. Always confirm current availability with the study team.

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