Brazilian Lung Immunotherapy Study

Phase 2

Completed

• Conditions: Lung Neoplasm
• Interventions: Drug: Alectinib; Drug: Nivolumab; Drug: Erlotinib; Drug: Pembrolizumab

• Registration Number: NCT05081674
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

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 Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALK-translocated	Alectinib	1. st line Alectinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel
PD-L1< 50%	Nivolumab	1. st line Carboplatin pemetrexed 2. nd line nivolumab 3. rd line Docetaxel
EGFR-mutant	Erlotinib	1. st line Erlotinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel
PD-L1 >= 50%	Pembrolizumab	1. st line Pembrolizumab 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Municipal Vila Santa Catarina; 🇧🇷 São Paulo, Brazil