Clinical trial NCT04285866: Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
Official title: Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Cell Lung Cancer (SCLC)
Keywords: Locally advanced small cell lung cancer
SCLC
lung cancer
durvalumab after chemotherapy
real world data
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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 outcomes:
measure: 1-year survival rate
timeFrame: 1 year
measure: To describe adverse events of special interest (AESIs)
timeFrame: 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
measure: Time and site of disease progression or relapse
timeFrame: From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
state: A Coruña
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
state: Barcelona
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran canaria
state: Gran Canaria
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Llàtzer
state: Illes Balears
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: País Vasco
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Nuestra Señora de Candelaria
state: Tenerife
city: Alzira
country: Spain
facility: Hospital Universitario De La Ribera
state: Valencia
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: A Coruña
country: Spain
facility: Hospital de A Coruña
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Consorci Mar Parc de Salut de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Clínico San Cecilio
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital de Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Ourense
country: Spain
facility: Complexo Hospitalario de Ourense
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Universitari i Politécnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Fundación GECP Investigator
name: Pilar Garrido, MD
role: STUDY_CHAIR
References: