A Study of the Safety of Atezolizumab in Participants With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina
Completed
- Conditions
- Carcinoma, Non-small-cell Lung
- Registration Number
- NCT03321695
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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
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Exclusion Criteria
- Contraindicated atezolizumab therapy
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 2 years Duration of Response (DOR) Up to approximately 2 years Progression-Free Survival (PFS) 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
Trial Locations
- Locations (1)
Productos Roche S.A. Quimica e Industrial, División Farmacéutica
🇦🇷Buenos Aires, Argentina