Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy. (S-REAL)

Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.

This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study.

The study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer (SCLC)
• Intervention / Treatment: Drug: Durvalumab

Detailed Description

Lung Cancer represent approximately 13% of total cancer diagnoses worldwide and continues to be the leading cause of cancer-related mortality. Stage III represents between 25-30% of NSCLC and the majority of them are unresectable. The standard treatment in unresectable patients was chemoradiotherapy consurrently if possible.

The PACIFIC study is a phase III study to evaluate the efficacy and safety of durvalumab as a sequential therapy concurrent platinum-based chemotherapy and thoracic RT. The study was positive for both primary endpoints progression-free survival and overall survival. After that, it was decided to open an early acces programme ti provide acces to durvalumab for patients with locally advanced, unresectable NSCLC (stage III) tho have not progressed following chemoradiation.

This observational study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world.

The study will include all patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.

The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival. Other secondary objectives are:

To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate, to describe adverse events of special interests, to stimate time and sites of disease progression or relapse in metastatic setting, to describe details on durvalumab treatment, to describe demographic and clinical characteristics of stage III unresectable NSCLC patients treated with Durvalumab, to describe previous chemoradiotherapy strategy, to describe the baseline staging status, to further assess subsequent treatments pattern at the time of disease progression including duration of therapy and type of therapy, and to explore healthcare resource utilization while on durvalumab treatment.

• Study Type: Observational
• Enrollment (Actual): 245

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Hospital de A Coruña
  • Alicante, Spain, 03010
    • Hospital General de Alicante
  • Barcelona, Spain, 08003
    • Consorci Mar Parc de Salut de Barcelona
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Granada, Spain, 18016
    • Hospital Universitario Clínico San Cecilio
  • Guadalajara, Spain, 19002
    • Hospital Universitario de Guadalajara
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaén
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Madrid, Spain, 28006
    • Hospital La Princesa
  • Madrid, Spain, 28702
    • Hospital Universitario Infanta Sofía
  • Madrid, Spain, 28050
    • Hospital de Sanchinarro
  • Ourense, Spain, 32005
    • Complexo Hospitalario de Ourense
  • Salamanca, Spain, 37007
    • Hospital Clinico Universitario de Salamanca
  • Segovia, Spain, 40002
    • Hospital General de Segovia
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocio
  • Toledo, Spain, 45071
    • Hospital Virgen De La Salud
  • Valencia, Spain, 46009
    • Hospital Universitari I Politecnic La Fe
  • Valladolid, Spain, 47003
    • Hospital Clínico Universitario de Valladolid
  • Zaragoza, Spain, 50009
    • Hospital Clinico Lozano Blesa
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15706
      • Hospital Clinico Universitario de Santiago
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol
    • Granollers, Barcelona, Spain, 08402
      • Hospital General de Granollers
    • Sabadell, Barcelona, Spain, 08208
      • Corporació Sanitària Parc Taulí
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Marques de Valdecilla
  • Cataluña
    • Barcelona, Cataluña, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
  • Gran Canaria
    • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016
      • Hospital Universitario Insular de Gran Canaria
  • Illes Balears
    • Palma De Mallorca, Illes Balears, Spain, 07198
      • Hospital Universitario Son Llatzer
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
  • País Vasco
    • Donostia, País Vasco, Spain, 20014
      • Hospital Universitario de Donostia
  • Tenerife
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
      • Hospital Nuestra Senora de Candelaria
  • Valencia
    • Alzira, Valencia, Spain, 46600
      • Hospital Universitario de La Ribera
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital Universitario de Basurto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who have parcipated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.

Description

Inclusion Criteria:

1. Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8).
2. Age ≥ 18 years at time of study Entry
3. Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
4. Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.
5. Patients must have been treated with at least one dose of durvalumab within the EAP
6. Alive patients must have signed, dated and IRB/EC-approved written informed consent* form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Exclusion Criteria:

1. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
2. Patients who were accepted in the EAP, but did not receive treatment.
3. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Durvalumab Group; Patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.	Drug: Durvalumab; Durvalumab after chemoradiotherapy; Other Names: MEDI4736

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS	From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year survival rate	To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate.	1 year
To describe adverse events of special interest (AESIs)	To describe AESIs leading to treatment temporary interruption or permanent discontinuation of durvalumab, or which require interventions of concomitant use of corticosteroids, immunosupressants and/or endocrine therapies.	From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months
Time and site of disease progression or relapse	To estimate time and sites of disease progression or relapse in metastatic setting.	From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Fundación GECP
• Investigators: Study Chair: Pilar Garrido, MD, Fundación GECP Investigator

Publications and helpful links

Helpful Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; real world data; SCLC; Locally advanced small cell lung cancer; durvalumab after chemotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab
• Other Study ID Numbers: GECP 19/02_S-REAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No