Brazilian Lung Immunotherapy Study

NCT05081674 | Completed Phase 2

• 1 other identifier: 4009-19
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm

Keywords

Non-small cell lung cancer; NSCLC; Lung adenocarcinoma; Squamous cell carcinoma of the lung; Immunotherapy; PD-1; Nivolumab; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Total cost of therapy

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

  Up to 3 years after starting systemic therapy

Secondary Outcomes (2)

• Median overall survival

  Up to 3 years after starting systemic therapy

• Prevalence of ALK, EGFR, PD-L1>=50%

  Up to 3 years after starting systemic therapy

Study Arms (4)

ALK-translocated

ACTIVE COMPARATOR

1. st line Alectinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel

Drug: Alectinib

EGFR-mutant

ACTIVE COMPARATOR

1. st line Erlotinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel

Drug: Erlotinib

PD-L1 >= 50%

ACTIVE COMPARATOR

1. st line Pembrolizumab 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel

Drug: Pembrolizumab

PD-L1< 50%

ACTIVE COMPARATOR

1. st line Carboplatin pemetrexed 2. nd line nivolumab 3. rd line Docetaxel

Drug: Nivolumab

Interventions

Alectinib DRUG

600mg 1OD

Also known as: Alecensa

ALK-translocated

Pembrolizumab DRUG

200mg every 21 days

Also known as: Keytruda

PD-L1 >= 50%

Nivolumab DRUG

6mg/kg every 4 weeks

Also known as: Opdivo

PD-L1< 50%

Erlotinib DRUG

150mg

Also known as: Tarceva

EGFR-mutant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate cardiac, renal, liver of bone-marrow function
• Plan to undergo definitive radiation or curative surgery
• Consent withdraw

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital Municipal Vila Santa Catarina

São Paulo, 04378-500, Brazil

Location

Related Links

• Web site of the Brazilian Ministry of Health

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

alectinib; pembrolizumab; Nivolumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Diogo Gomes, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: January 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)