NCT05081674

Brazilian Lung Immunotherapy Study

Evaluation of Costs and Outcomes of the Implementation of Treatment Protocol Based on Rational Utilization of Anti-PD1 Agents in Patients With Non-small-cell Lung Cancer in the Brazilian Public Health System

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with metastatic non-small-cell lung cancer will undergo tumor testing for EGFR (by PCR), ALK and PD-L1 (by immunohistochemistry) and receive therapy based on these results. * Patients with ALK-translocated tumors will receive first-line therapy with Alectinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel * Patients with EGFR-mutated tumors will receive first-line therapy with Erlotinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel * Patients with ALK/EGFRwt tumors and PD-L1\>=50% will receive first-line pembrolizumab, second-line carboplatin-pemetrexed and third line docetaxel * Patients with ALK/EGFRwt tumors and PD-L1\<50% will receive first-line carboplatin-pemetrexed, second-line nivolumab and third line docetaxel. Therapy costs will be estimated, including hospital admissions and reported for each treatment arm.

Conditions

• Lung Neoplasm

Interventions

Type	Name	Description
DRUG	Alectinib	600mg 1OD
DRUG	Pembrolizumab	200mg every 21 days
DRUG	Nivolumab	6mg/kg every 4 weeks
DRUG	Erlotinib	150mg

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-06-30
• Completion: 2023-07-30
• First posted: 2021-10-18
• Last updated: 2023-10-11

Locations

1 site across 1 country: Brazil