Brazilian Lung Immunotherapy Study

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT05081674
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alectinib — DRUG
    600mg 1OD
  • Pembrolizumab — DRUG
    200mg every 21 days
  • Nivolumab — DRUG
    6mg/kg every 4 weeks
  • Erlotinib — DRUG
    150mg

Study Details

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.

Key Dates

Start date
Jan 1, 2020
Status verified
Oct 2021
Primary completion
Jun 30, 2023
Completion
Jul 30, 2023

Study Design

Enrollment
154 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: ALK-translocated
    1. st line Alectinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel
  • Active Comparator: EGFR-mutant
    1. st line Erlotinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel
  • Active Comparator: PD-L1 >= 50%
    1. st line Pembrolizumab 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel
  • Active Comparator: PD-L1< 50%
    1. st line Carboplatin pemetrexed 2. nd line nivolumab 3. rd line Docetaxel

Primary Outcome Measure

Total cost of therapy [ Time Frame: Up to 3 years after starting systemic therapy ]

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