Brazilian Lung Immunotherapy Study (BLISS)

Hospital Israelita Albert Einstein

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasm

Treatments: Drug: Pembrolizumab; Drug: Nivolumab; Drug: Erlotinib; Drug: Alectinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05081674

4009-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

ALK-translocated

Active Comparator group

Description:

1. st line Alectinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel

Treatment:

Drug: Alectinib

EGFR-mutant

Active Comparator group

Description:

1. st line Erlotinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel

Treatment:

Drug: Erlotinib

PD-L1 >= 50%

Active Comparator group

Description:

1. st line Pembrolizumab 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel

Treatment:

Drug: Pembrolizumab

PD-L1< 50%

Active Comparator group

Description:

1. st line Carboplatin pemetrexed 2. nd line nivolumab 3. rd line Docetaxel

Treatment:

Drug: Nivolumab