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

Small Cell Lung Cancer (SCLC) Clinical Trial

— S-REAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285866
• Other study ID #: GECP 19/02_S-REAL
• Status: Completed
• Start date: May 21, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Fundación GECP
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer (SCLC)
• Small Cell Lung Carcinoma

Intervention

Drug:
• Durvalumab
Durvalumab after chemoradiotherapy

Locations

Country	Name	City	State
Spain	Hospital de A Coruña	A Coruña
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Universitario De La Ribera	Alzira	Valencia
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Consorci Mar Parc de Salut de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital Universitario de Basurto	Bilbao	Vizcaya
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario de Donostia	Donostia	País Vasco
Spain	Hospital Universitario Clínico San Cecilio	Granada
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario Insular de Gran canaria	Las Palmas De Gran Canaria	Gran Canaria
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital de Sanchinarro	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Infanta Sofía	Madrid
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Complexo Hospitalario de Ourense	Ourense
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Son Llàtzer	Palma De Mallorca	Illes Balears
Spain	Clínica Universidad de Navarra	Pamplona	Navarra
Spain	Corporació Sanitaria Parc Taulí	Sabadell	Barcelona
Spain	Hospital Clínico Universitario de Salamanca	Salamanca
Spain	Hospital Nuestra Señora de Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela	A Coruña
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Virgen del Rocío	Sevilla
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

Sponsors (1)

Lead Sponsor	Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-year survival rate	To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate.	1 year
Secondary	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
Secondary	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

External Links

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