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Prospective Observational Study To Identify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management (IDEALK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679170
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Prospective Observational Study To Identify Patients With Advanced/metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management under clinical practice (IDEALK)

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Drug: Crizotinib

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: PROSPECTIVE OBSERVATIONAL STUDY TO IDENTIFY PATIENTS WITH ADVANCED/METASTATIC NSCLC AND ALK TRANSLOCATION AND TO ESTABLISH THEIR THERAPEUTIC MANAGEMENT (IDEALK)
Actual Study Start Date : June 29, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Group/Cohort Intervention/treatment
Routine clinical practice group (NSCLC ALK+)
Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+
Drug: Crizotinib
Treatment with crizotinib following routine clinical practice




Primary Outcome Measures :
  1. Incidence of ALK-positive NSCLC in Spain [ Time Frame: 2 years ]
    Real incidence of ALK-positive NSCLC in Spain

  2. Progression Free Survival [PFS] [ Time Frame: 2 years ]
    Efficacy in terms of PFS of Crizotinib in patients with advanced ALK+ NSCLC



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NSCLS Patients, ALK + Confirmed
Criteria

Inclusion Criteria:

  • Patients with Advanced or metastatic non-small cell lung cancer
  • Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement
  • Age > 18 years
  • For the patients that will be recruited prospectively: Patients must have a signed informed consent document.
  • For the treatment sub-study, patients must also meet the following criteria

    • Confirmed anaplastic lymphoma kinase (ALK)-positive tumour
    • Patients treated with crizotinib under routine clinical practice
    • Patients with a minimum data registered at the medical history

Exclusion Criteria:

  • Any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679170


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02679170    
Other Study ID Numbers: A8081057
IDEALK ( Other Identifier: Alias Study Number )
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
ALK+
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action