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NCT03321695 Clinical Trial

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

Carcinoma, Non-small-cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03321695
Other study ID # ML39852
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 27, 2017
Est. completion date March 2, 2019

Study information
Verified date March 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date March 2, 2019
Est. primary completion date March 2, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Productos Roche S.A. Quimica e Industrial, División Farmacéutica Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Adverse Events Up to approximately 2 years
Secondary Overall Survival (OS) Up to approximately 2 years
Secondary Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR) Up to approximately 2 years
Secondary Duration of Response (DOR) Up to approximately 2 years
Secondary Progression-Free Survival (PFS) Up to approximately 2 years
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