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

NCT04948411 | Completed

• 1 other identifier: LACOG 0120
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 4

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

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

  June of 2018

Other Outcomes (3)

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

  June of 2018

• - To describe Overall survival at 3 years, defined as the time from start of durvalumab therapy to death from any cause.

  June of 2018

• - To describe the sequence of lines of treatment in patients which have disease progression after durvalumab.

  June of 2018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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..

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead

Study Sites (4)

Núcleo de Oncologia da Bahia S.A

Salvador, Estado de Bahia, 41810-011, Brazil

Location

Instituto Mário Penna

Belo Horizonte, Minas Gerais, 30380-420, Brazil

Location

BP - A Beneficência Portuguesa de São Paulo

São Paulo, 01323-001, Brazil

Location

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

São Paulo, 01409-003, Brazil

Location

Related Publications (4)

• 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.

  PMID: 28881918 BACKGROUND

• 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.

  PMID: 28885881 BACKGROUND

• 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.

  PMID: 18718891 BACKGROUND

• Zukin M, Gondim V, Shimada AK, Lima EMEA, Mathias C, Barra WF, William Junior WN, Padoan M, Bittencourt Y, Yamamura R, Silva CEB, Rossato LJ, Monteiro CA, Jesus RG, Gossling G, Gelatti ACZ. Durvalumab as consolidation therapy in patients who received chemoradiotherapy for unresectable stage III NSCLC: Real-world data from an expanded access program in Brazil (LACOG 0120). J Bras Pneumol. 2025 Jan 13;50(6):e20240228. doi: 10.36416/1806-3756/e20240228. eCollection 2025.

  PMID: 39813498 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: September 30, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

BR (4)