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

NCT03321695 | Completed

• 1 other identifier: ML39852
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-small-cell Lung

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events

  Up to approximately 2 years

Secondary Outcomes (4)

• 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

• Duration of Response (DOR)

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Contraindicated atezolizumab therapy

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

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

Buenos Aires, B1610BAL, Argentina

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 26, 2017
• Study Start: December 27, 2017
• Primary Completion: March 2, 2019
• Study Completion: March 2, 2019
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

AR (1)