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CompletedPhase 3NCT01154140
Official study title

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

Study summary

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedtreatment and treatment

The study team can explain what participation involves.

Who it may be forALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 6, 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?249 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: treatment; Drug: treatment
02
Explore related studies

How this study is categorized

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

Biomarkers
ALK→
Treatment approach
Targeted therapy→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
  • Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  • Positive for translocation or inversion events involving the ALK gene locus
  • No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  • Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome \[PRO\] measures.
  • 18 years of age or older with the exception of India which has an upper age limit of 65 years old
Reasons someone may not be able to joinExclusion criteria
  • Current treatment on another therapeutic clinical trial.
  • Prior therapy directly targeting ALK.
  • Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade \>=2, uncontrolled atrial fibrillation of any grade, or QTc interval \>470 msec.
  • Pregnancy or breastfeeding.
  • Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
  • Known HIV infection
  • Known interstitial lung disease or interstitial fibrosis
  • Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

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

  • Tower Cancer Research FoundationBeverly Hills, California
  • Tower Hematology Oncology Medical GroupBeverly Hills, California
  • CCTAPFontana, California
  • Loma Linda University Cancer CenterLoma Linda, California
  • Loma Linda University Cancer Center (LLUCC)-Schuman PavilionLoma Linda, California
  • Loma Linda University Medical CenterLoma Linda, California
  • CCTAPLos Angeles, California
  • Kaiser Permanente Southern CaliforniaSan Diego, California
  • CCTAPSan Diego, California
  • Georgetown University HospitalWashington D.C., District of Columbia
  • Research Pharmacy, Georgetown University Medical CenterWashington D.C., District of Columbia
  • Lynn Cancer Institute Center for Hematology OncologyBoca Raton, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 6, 2017. Always confirm current availability with the study team.

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