drugset / Trial / NCT05081674

Brazilian Lung Immunotherapy Study

NCT05081674

Non-randomizedParallel-groupOpen-labelHealth-services research

Summary

Immunotherapy with anti-PD-1/PD-L1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. However, it has not been incorporated in the Brazilian Public Health System because of concerns about patient eligibility, safety and costs. It is known that simple biomarkers can be used to select patients for immunotherapy, such as EGRF, ALK and PD-L1 status in the tumors. We created a treatment protocol based on these 3 markers and treated 154 patients with non-small-cell-lung cancer in a Public Hospital in Brazil. The goal of this project is to identify the prevalence of these markers in the Brazilian population (to estimate patient eligibility), outcomes and costs of therapy.

Timeline

Start
2020-01-01
Primary completion
2023-06-30
Completion
2023-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alectinib Small molecule 600 mg
Comparator Erlotinib Small molecule 150 mg
Comparator Nivolumab Monoclonal antibody 6 mg/kg
Comparator Pembrolizumab Monoclonal antibody 200 mg

Indications