Trials Sponsors Conditions Drugs Pricing

Conditions

Small Cell Lung Cancer (SCLC)

Keywords

Locally advanced small cell lung cancerSCLClung cancerdurvalumab after chemotherapyreal world data

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

1-year survival rate
1 year
To describe adverse events of special interest (AESIs)
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
From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months

Study Arms (1)

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

Interventions

DurvalumabDrug

Durvalumab after chemoradiotherapy

Also known as: MEDI4736

Durvalumab Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

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).

Sponsors & Collaborators

Fundación GECP
Otherlead

Study Sites (39)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Hospital Universitario Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Basque Country, 20014, Spain

Hospital Marqués de Valdecilla

MeSH Terms

Conditions

Small Cell Lung CarcinomaLung Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Pilar Garrido, MD
Fundación GECP Investigator
STUDY CHAIR

Enrollment

245 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

May 21, 2020

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Durvalumab Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (39)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Durvalumab Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (39)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations