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

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: Carcinoma, Non-small-cell Lung

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

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