Clinical trial NCT05081674: Brazilian Lung Immunotherapy Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasm
Keywords: Non-small cell lung cancer
NSCLC
Lung adenocarcinoma
Squamous cell carcinoma of the lung
Immunotherapy
PD-1
Nivolumab
Pembrolizumab
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2021-10-18
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are treated in one of 4 different arms based on biomarker testing. There is no randomization or cross-over
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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

Primary outcomes:
measure: Total cost of therapy
timeFrame: Up to 3 years after starting systemic therapy
Secondary outcomes:
measure: Median overall survival
timeFrame: Up to 3 years after starting systemic therapy
measure: Prevalence of ALK, EGFR, PD-L1>=50%
timeFrame: Up to 3 years after starting systemic therapy
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Municipal Vila Santa Catarina
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Diogo Gomes, MD
role: PRINCIPAL_INVESTIGATOR
References: