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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948411
• Other study ID #: LACOG 0120
• Status: Completed
• Start date: September 30, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2024
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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..

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Brazil	Instituto Mário Penna	Belo Horizonte	Minas Gerais
Brazil	Núcleo de Oncologia da Bahia S.A	Salvador	Bahia
Brazil	BP - A Beneficência Portuguesa de São Paulo	São Paulo
Brazil	Sociedade Beneficente de Senhoras Hospital Sírio-Libanês	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8. — View Citation

De Ruysscher D, Botterweck A, Dirx M, Pijls-Johannesma M, Wanders R, Hochstenbag M, Dingemans AM, Bootsma G, Geraedts W, Simons J, Pitz C, Lambin P. Eligibility for concurrent chemotherapy and radiotherapy of locally advanced lung cancer patients: a prospective, population-based study. Ann Oncol. 2009 Jan;20(1):98-102. doi: 10.1093/annonc/mdn559. Epub 2008 Aug 20. — View Citation

Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	- To describe Overall response rate, defined as the proportion of patients who have a partial or complete response to durvalumab therapy.		June of 2018
Other	- To describe Overall survival at 3 years, defined as the time from start of durvalumab therapy to death from any cause.		June of 2018
Other	- To describe the sequence of lines of treatment in patients which have disease progression after durvalumab.		June of 2018
Primary	Describe real world data on PFS of patients treated with Durvalumab in stage III NSCLC in the EAP in Brazil		June of 2018