Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05081674
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2021-10-05
Brief Title:
Brazilian Lung Immunotherapy Study
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLISS
Brief Summary:
Immunotherapy with anti-PD-1PD-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 ALKEGFRwt tumors and PD-L150 will receive first-line pembrolizumab second-line carboplatin-pemetrexed and third line docetaxel
Patients with ALKEGFRwt tumors and PD-L150 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
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 ALKEGFRwt tumors and PD-L150 will receive first-line pembrolizumab second-line carboplatin-pemetrexed and third line docetaxel
Patients with ALKEGFRwt tumors and PD-L150 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None