Clinical trial NCT04948411: Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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


Eligibility 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..

Primary outcomes:
measure: Describe real world data on PFS of patients treated with Durvalumab in stage III NSCLC in the EAP in Brazil
timeFrame: June of 2018
Secondary outcomes:
Other outcomes:
measure: - To describe Overall response rate, defined as the proportion of patients who have a partial or complete response to durvalumab therapy.
timeFrame: June of 2018
measure: - To describe Overall survival at 3 years, defined as the time from start of durvalumab therapy to death from any cause.
timeFrame: June of 2018
measure: - To describe the sequence of lines of treatment in patients which have disease progression after durvalumab.
timeFrame: June of 2018
Locations:
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia S.A
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Instituto Mário Penna
state: Minas Gerais
city: São Paulo
country: Brazil
facility: BP - A Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sírio-Libanês
Study officials:
References:
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.
citation: 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.
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.