Lung Neoplasm
Conditions
Keywords
Non-small cell lung cancer, NSCLC, Lung adenocarcinoma, Squamous cell carcinoma of the lung, Immunotherapy, PD-1, Nivolumab, Pembrolizumab
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.
Interventions
DRUGAlectinib
600mg 1OD
DRUGPembrolizumab
200mg every 21 days
DRUGNivolumab
6mg/kg every 4 weeks
DRUGErlotinib
150mg
Sponsors
Ministry of Health, Brazil
Hospital Israelita Albert Einstein
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Patients are treated in one of 4 different arms based on biomarker testing. There is no randomization or cross-over
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total cost of therapy | Up to 3 years after starting systemic therapy | Sum of all direct costs involved in patient care, including admissions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median overall survival | Up to 3 years after starting systemic therapy | Median survival from first systemic therapy |
| Prevalence of ALK, EGFR, PD-L1>=50% | Up to 3 years after starting systemic therapy | Prevalence of the 3 biomarkers in an unselected NSCLC population in Brazil |
Countries
Brazil
Outcome results
None listed