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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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.
Therapy costs will be estimated, including hospital admissions and reported for each treatment arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALK-translocated | Active Comparator |
|
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| EGFR-mutant | Active Comparator |
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| PD-L1 >= 50% | Active Comparator |
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| PD-L1< 50% | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | 600mg 1OD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total cost of therapy | Sum of all direct costs involved in patient care, including admissions | Up to 3 years after starting systemic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Median overall survival | Median survival from first systemic therapy | Up to 3 years after starting systemic therapy |
| Prevalence of ALK, EGFR, PD-L1>=50% | Prevalence of the 3 biomarkers in an unselected NSCLC population in Brazil |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diogo Gomes, MD | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Municipal Vila Santa Catarina | São Paulo | 04378-500 | Brazil |
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| Label | URL |
|---|---|
| Web site of the Brazilian Ministry of Health | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582670 | alectinib |
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Patients are treated in one of 4 different arms based on biomarker testing. There is no randomization or cross-over
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| Pembrolizumab |
| Drug |
200mg every 21 days |
|
|
| Nivolumab | Drug | 6mg/kg every 4 weeks |
|
|
| Erlotinib | Drug | 150mg |
|
|
| Up to 3 years after starting systemic therapy |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |