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Trial record 1 of 1 for:    NCT04948411
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Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil (EAP DURVA LUNG)

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ClinicalTrials.gov Identifier: NCT04948411
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

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

Condition or disease
Carcinoma, Non-Small-Cell Lung

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Years
Official Title: Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil.
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2023



Primary Outcome Measures :
  1. 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 Outcome Measures:
  1. - 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 ]
  2. - 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 ]
  3. - To describe the sequence of lines of treatment in patients which have disease progression after durvalumab. [ Time Frame: June of 2018 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will include patients who have participated in the Durvalumab EAP in Brazil and have received at least 1 dose of Durvalumab.

To enter the EAP, patients with unresectable stage III NSCLC must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. It was preferred that treatment had started within approximately three months from end of radiation for patients to recover from treatment-related toxicities and/or for treating physicians to have adequate time to perform the baseline disease assessment. There was no fixed maximum duration for Durvalumab treatment. Treatment with Durvalumab continues until the physician determines its benefit for the patient.

Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04948411


Contacts
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Contact: Mauro Zukin, MD 55 21 2986-3232 zukin.mauro@gmail.com
Contact: Ana Gelatti, MD 55 51 3230-2507 anagelatti@yahoo.com.br

Locations
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Brazil
Núcleo de Oncologia da Bahia S.A Not yet recruiting
Salvador, Bahia, Brazil, 41810-011
Contact: Clarissa Maria de Cerqueira Mathias, MD    7140097085    pesquisaclinica@nob-ba.com.br   
Instituto Mário Penna Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30380-420
Contact: Ellias Magalhães e Abreu Lima, MD    55 31 33309100    ellias_lima@hotmail.com   
BP - A Beneficência Portuguesa de São Paulo Not yet recruiting
São Paulo, Brazil, 01323-001
Contact: William NASSIB WILLIAM JUNIOR, MD    1135055021      
Sociedade Beneficente de Senhoras Hospital Sírio-Libanês Recruiting
São Paulo, Brazil, 01409-003
Contact: Andrea Kazumi Shimada, MD    1133944751    PESQUISA@HSL.ORG.BR   
Sponsors and Collaborators
Latin American Cooperative Oncology Group
Publications:
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Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT04948411    
Other Study ID Numbers: LACOG 0120
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Latin American Cooperative Oncology Group:
Carcinoma, Non-Small-Cell Lung
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases