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

March 9, 2023 updated by: Hoffmann-La Roche

An Observational Study of the Safety of Atezolizumab in Patients 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1610BAL
        • Productos Roche S.A. Quimica e Industrial, División Farmacéutica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include participants with locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) who have received the indication for treatment with atezolizumab, as per local label (disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence after treatment with a platinum-based adjuvant/neoadjuvant regimen, and have progressed on an appropriate approved targeted therapy if their tumor has EGFR or ALK gene abnormalities) and who have no contraindication to atezolizumab therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Overall Survival (OS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2017

Primary Completion (Actual)

March 2, 2019

Study Completion (Actual)

March 2, 2019

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 26, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39852

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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