Brazilian Lung Immunotherapy Study

• Status: Active, not recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Israelita Albert Einstein
• Collaborator: Ministry of Health, Brazil
• Treatments: Erlotinib Hydrochloride; Nivolumab; Pembrolizumab

Criteria

Inclusion Criteria:

• Stage IIIc or IV Non-small cell lung cancer

• Good performance status (ECOG 0-2)

• Available tissue for tumor markers

• Plan to undergo systemic therapy

Exclusion Criteria:

• Inadequate cardiac, renal, liver of bone-marrow function

• Plan to undergo definitive radiation or curative surgery

• Consent withdraw