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A Study of the Safety of Atezolizumab in Participants With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03321695
Collaborator
(none)
60
Enrollment
24.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a study of the safety and effectiveness of atezolizumab in participants with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Participants also will have progressed on an appropriate approved targeted therapy if their tumor has epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities treated in common clinical practice settings in Argentina.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study of the Safety of Atezolizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina
    Anticipated Study Start Date :
    Dec 11, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2019
    Anticipated Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Adverse Events [Up to approximately 2 years]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to approximately 2 years]

    2. Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR) [Up to approximately 2 years]

    3. Duration of Response (DOR) [Up to approximately 2 years]

    4. Progression-Free Survival (PFS) [Up to approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)

    • Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)

    • Have received at least one dose of atezolizumab as per local label and clinical practice

    Exclusion Criteria:
    • Contraindicated atezolizumab therapy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03321695
    Other Study ID Numbers:
    • ML39852
    First Posted:
    Oct 26, 2017
    Last Update Posted:
    Dec 13, 2017
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Dec 13, 2017