Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.

NCT ID: NCT04285866

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2021-12-31

Brief Summary

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.

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.

Conditions

Small Cell Lung Cancer (SCLC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Durvalumab

Intervention Type: DRUG

Durvalumab after chemoradiotherapy

Interventions

Durvalumab

Durvalumab after chemoradiotherapy

Intervention Type: DRUG

Other Intervention Names

MEDI4736

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación GECP

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pilar Garrido, MD

Role: STUDY_CHAIR

Fundación GECP Investigator

Locations

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital Universitario Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital General de Granollers

Granollers, Barcelona, Spain

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Basque Country, Spain

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital Costa del Sol

Marbella, Málaga, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Universitario De La Ribera

Alzira, Valencia, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

Hospital de A Coruña

A Coruña, , Spain

Hospital General de Alicante

Alicante, , Spain

Consorci Mar Parc de Salut de Barcelona

Barcelona, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Universitario Clínico San Cecilio

Granada, , Spain

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Complejo Hospitalario de Jaén

Jaén, , Spain

Hospital La Princesa

Madrid, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Hospital de Sanchinarro

Madrid, , Spain

Hospital Universitario Infanta Sofía

Madrid, , Spain

Complexo Hospitalario de Ourense

Ourense, , Spain

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Hospital General de Segovia

Segovia, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Hospital Universitari i Politécnic La Fe

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Clínico Lozano Blesa

Zaragoza, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

Related Links

http://www.gecp.org

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

Other Identifiers

GECP 19/02_S-REAL

Identifier Type: -

Identifier Source: org_study_id