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NCT Number: NCT05081674

Brazilian Lung Immunotherapy Study

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.

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Key information

Conditions

Lung Neoplasm Adenocarcinoma Adenocarcinoma of Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Municipal Vila Santa Catarina

São Paulo, 04378-500, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alectinib

Drug

600mg 1OD

Other names: Alecensa

Pembrolizumab

Drug

200mg every 21 days

Other names: Keytruda

Nivolumab

Drug

6mg/kg every 4 weeks

Other names: Opdivo

Erlotinib

Drug

150mg

Other names: Tarceva

Primary outcomes

  1. Total cost of therapy

    Time frame: Up to 3 years after starting systemic therapy

    Sum of all direct costs involved in patient care, including admissions

Secondary outcomes

  1. Median overall survival

    Time frame: Up to 3 years after starting systemic therapy

    Median survival from first systemic therapy

  2. Prevalence of ALK, EGFR, PD-L1>=50%

    Time frame: Up to 3 years after starting systemic therapy

    Prevalence of the 3 biomarkers in an unselected NSCLC population in Brazil

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study 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

Acronym: BLISS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2021
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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