Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil

Durvalumab as maintenance in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real World Data from an Expanded Access Program in Brazil

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Núcleo de Oncologia da Bahia S.A, Salvador, Estado de Bahia, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with unresectable stage III NSCLC who completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression
Patients who have participated in the Durvalumab EAP in Brazil and have received at least one dose of Durvalumab in the EAP..

Treatment and study plan

Primary outcomes

Describe real world data on PFS of patients treated with Durvalumab in stage III NSCLC in the EAP in Brazil

Time frame: June of 2018

Other outcomes

- To describe Overall response rate, defined as the proportion of patients who have a partial or complete response to durvalumab therapy.

Time frame: June of 2018
- To describe Overall survival at 3 years, defined as the time from start of durvalumab therapy to death from any cause.

Time frame: June of 2018
- To describe the sequence of lines of treatment in patients which have disease progression after durvalumab.

Time frame: June of 2018

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Registry information

Official study title

Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil.

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jul 2, 2021
Registry last updated: Feb 21, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed