Brazilian Lung Immunotherapy Study (BLISS)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasm
• Intervention / Treatment: Drug: Alectinib; Drug: Erlotinib; Drug: Pembrolizumab; Drug: Nivolumab

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04378-500
    • Hospital Municipal Vila Santa Catarina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Up to 3 years after starting systemic therapy

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Ministry of Health, Brazil
• Investigators: Principal Investigator: Diogo Gomes, MD, Hospital Israelita Albert Einstein

Publications and helpful links

Helpful Links

• Web site of the Brazilian Ministry of Health

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: NSCLC; Nivolumab; Immunotherapy; Non-small cell lung cancer; Pembrolizumab; PD-1; Lung adenocarcinoma; Squamous cell carcinoma of the lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Erlotinib Hydrochloride; Nivolumab; Pembrolizumab
• Other Study ID Numbers: 4009-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No