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 |
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Recruitment Status :
Recruiting
First Posted : July 2, 2021
Last Update Posted : November 29, 2022
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| Condition or disease |
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| Carcinoma, Non-Small-Cell Lung |
| 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 |
- 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 ]
- - 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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.
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..
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
| Contact: Mauro Zukin, MD | 55 21 2986-3232 | zukin.mauro@gmail.com | |
| Contact: Ana Gelatti, MD | 55 51 3230-2507 | anagelatti@yahoo.com.br |
| 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 | |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma, Non-Small-Cell Lung |
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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 |