Brazilian Lung Immunotherapy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-07-30

Brief Summary

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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.

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Detailed Description

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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

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Lung Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients are treated in one of 4 different arms based on biomarker testing. There is no randomization or cross-over

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ALK-translocated

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

Group Type ACTIVE_COMPARATOR

Alectinib

Intervention Type DRUG

600mg 1OD

EGFR-mutant

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

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

150mg

PD-L1 >= 50%

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

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type DRUG

200mg every 21 days

PD-L1< 50%

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

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type DRUG

6mg/kg every 4 weeks

Interventions

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Alectinib

600mg 1OD

Intervention Type DRUG

Pembrolizumab

200mg every 21 days

Intervention Type DRUG

Nivolumab

6mg/kg every 4 weeks

Intervention Type DRUG

Erlotinib

150mg

Intervention Type DRUG

Other Intervention Names

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Alecensa Keytruda Opdivo Tarceva

Eligibility Criteria

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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