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CompletedPhase 3NCT00932893
Official study title

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Study summary

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-02341066 and Pemetrexed

Plus 1 other study approaches.

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 Jan 2, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?264 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Pfizer
Interventions being studied
Drug: PF-02341066; Drug: Pemetrexed; Drug: Docetaxel
02
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→
Treatment approach
Chemotherapy→
03
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
  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for the ALK fusion gene (test provided by a central laboratory)
  • must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
  • tumors must be measurable
Reasons someone may not be able to joinExclusion criteria
  • prior treatment with PF-02341066
  • current treatment in another clinical trial

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

04
Study sites

U.S. locations

  • University of Arkansas for Medical Research, Winthrop Rockefeller Cancer InstituteLittle Rock, Arkansas
  • Comprehensive Blood and Cancer CenterBakersfield, California
  • Tower Cancer Research FoundationBeverly Hills, California
  • Tower Hematology Oncology Medical GroupBeverly Hills, California
  • UCSD Medical Center -La JollaLa Jolla, California
  • Moores UC San Diego Cancer CenterLa Jolla, California
  • Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLALos Angeles, California
  • Ronald Reagan UCLA Medical CenterLos Angeles, California
  • UCLA Hematology OncologyLos Angeles, California
  • UCLA Ophthalmic Oncology CenterLos Angeles, California
  • University of California-Los AngelesLos Angeles, California
  • Ship Drug To : Kevin Kong- University of California, Irvine-PharmacyOrange, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 2, 2017. Always confirm current availability with the study team.

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