BLISS: Brazilian Lung Immunotherapy Study

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05081674

Collaborator

Ministry of Health, Brazil (Other)

154

Enrollment

Location

Arms

47.9

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasm	Drug: Alectinib Drug: Pembrolizumab Drug: Nivolumab Drug: Erlotinib	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ALK-translocated st line Alectinib nd line Carboplatin pemetrexed rd line Docetaxel	Drug: Alectinib 600mg 1OD Other Names: Alecensa
Active Comparator: EGFR-mutant st line Erlotinib nd line Carboplatin pemetrexed rd line Docetaxel	Drug: Erlotinib 150mg Other Names: Tarceva
Active Comparator: PD-L1 >= 50% st line Pembrolizumab nd line Carboplatin pemetrexed rd line Docetaxel	Drug: Pembrolizumab 200mg every 21 days Other Names: Keytruda
Active Comparator: PD-L1< 50% st line Carboplatin pemetrexed nd line nivolumab rd line Docetaxel	Drug: Nivolumab 6mg/kg every 4 weeks Other Names: Opdivo

Outcome Measures

Primary Outcome Measures

Total cost of therapy [Up to 3 years after starting systemic therapy]
Sum of all direct costs involved in patient care, including admissions

Secondary Outcome Measures

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