Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 (PROFILE 1014)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 29, 2010
Last updated: November 6, 2014
Last verified: November 2014

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

Condition Intervention Phase
Non Squamous Lung Cancer
Drug: treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact. Progression Free Survival [PFS] based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory)

Secondary Outcome Measures:
  • Number of Participants With Objective Response. [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    Number of participants with Objective Response Rate [ORR ] documented by independent radiology laboratory, and Duration of Response [DR], Time to Response [TTR], intra-cranial and extra-cranial Disease Control Rate [DCR]

  • Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of crizotinib (including its active moieties, if appropriate) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Patient reported outcome measures of pain, dyspnea, or cough, disease/treatment-related symptoms, and general health status and Health Care Resource Utilization [HCRU] [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Overall Survival [OS] at 12 months, 18 months and overall [ Time Frame: 35 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 334
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: treatment
crizotinib 250mg orally continuous twice daily dosing
Active Comparator: B Drug: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion 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

Exclusion 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01154140

  Show 249 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT01154140     History of Changes
Other Study ID Numbers: A8081014, 2010-021336-33
Study First Received: June 29, 2010
Last Updated: November 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
open label
randomized Phase 3
first line treatment
non squamous lung cancer
ALK translocation event positive

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Respiratory Tract Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on November 25, 2014