Small Cell Lung Cancer (SCLC)S-REALNCT04285866
Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy.
An observational study of Small Cell Lung Cancer (SCLC), run by Fundación GECP at 39 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- Durvalumab
- How many people
- 245 participants
- Where
- 39 sitesSpain
- Study dates
- 21 May 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- Age ≥ 18 years at time of study Entry
- Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
- Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.
- Patients must have been treated with at least one dose of durvalumab within the EAP
- 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.
Who cannot join
- Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
- Patients who were accepted in the EAP, but did not receive treatment.
- Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Spain39 sites
Hospital de A Coruña
A Coruña, 15006
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital General de Alicante
Alicante, 03010
Hospital Universitario De La Ribera
Alzira, Valencia, 46600
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Consorci Mar Parc de Salut de Barcelona
Barcelona, 08003
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Universitario de Donostia
Donostia / San Sebastian, Basque Country, 20014
Hospital Universitario Clínico San Cecilio
Granada, 18016
Hospital General de Granollers
Granollers, Barcelona, 08402
Hospital Universitario de Guadalajara
Guadalajara, 19002
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital de Sanchinarro
Madrid, 28050
Hospital Universitario Infanta Sofía
Madrid, 28702
Hospital Costa del Sol
Marbella, Málaga, 29603
Complexo Hospitalario de Ourense
Ourense, 32005
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Universitario Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Hospital General de Segovia
Segovia, 40002
Hospital Virgen del Rocío
Seville, 41013
Hospital Virgen de la Salud
Toledo, 45071
Hospital Universitari i Politécnic La Fe
Valencia, 46009
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Clínico Lozano Blesa
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: 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.
Read the 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)
- Being tested
- Durvalumab
- Keywords
- Locally advanced small cell lung cancer, SCLC, lung cancer, durvalumab after chemotherapy, real world data
- Medical subject headings
- Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab after chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS
Measured: 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 (3)
1-year survival rate
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate.
Measured: 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.
Measured: 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.
Measured: From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start21 May 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Garrido, MD, Study chair, Fundación GECP Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285866
- Sponsor's protocol ID
- GECP 19/02_S-REAL
- Acronym
- S-REAL
- Status last verified
- Jun 2022
- First submitted
- 24 Feb 2020
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.
- ClinicalTrials.gov ID
- NCT04285866
- Acronym / sponsor ID
- S-REAL / GECP 19/02_S-REAL
- Conditions
- Small Cell Lung Cancer (SCLC)
- Keywords
- Locally advanced small cell lung cancer, SCLC, lung cancer, durvalumab after chemotherapy, real world data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab Group | – | Drug: DurvalumabPatients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
- Age ≥ 18 years at time of study Entry
- Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
- Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.
- Patients must have been treated with at least one dose of durvalumab within the EAP
Key exclusion criteria (3 listed)
- Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
- Patients who were accepted in the EAP, but did not receive treatment.
- Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab after chemoradiotherapy | Drug | Durvalumab Group |
Primary outcome
Progression Free Survival (PFS)
Time frame: 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
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS
3 secondary outcomes
1-year survival rate
Time frame: 1 year
To describe adverse events of special interest (AESIs)
Time frame: 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
Time frame: From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Garrido, MD study chair
Fundación GECP Investigator
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer (SCLC), run by Fundación GECP at 39 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.