Brazilian Lung Immunotherapy Study

Lung Neoplasm Clinical Trial

— BLISS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081674
• Other study ID #: 4009-19
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: October 2021
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

Drug:
• Alectinib
600mg 1OD
• Pembrolizumab
200mg every 21 days
• Nivolumab
6mg/kg every 4 weeks
• Erlotinib
150mg

Locations

Country	Name	City	State
Brazil	Hospital Municipal Vila Santa Catarina	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cost of therapy	Sum of all direct costs involved in patient care, including admissions	Up to 3 years after starting systemic therapy
Secondary	Median overall survival	Median survival from first systemic therapy	Up to 3 years after starting systemic therapy
Secondary	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

External Links

•   Web site of the Brazilian Ministry of Health