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OpenTrials
Completed

NCT Number: NCT03321695

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Productos Roche S.A. Quimica e Industrial, División Farmacéutica

Buenos Aires, B1610BAL, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 2 years

  2. Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)

    Time frame: Up to approximately 2 years

  3. Duration of Response (DOR)

    Time frame: Up to approximately 2 years

  4. Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational Study of the Safety of Atezolizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2017
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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