Trials Sponsors Conditions Drugs Pricing

Conditions

Non-small Cell Lung Cancer Stage III PDL1 Gene Mutation

Keywords

Lung CancerChemo radiotherapyctDNAInmunotherapy

Outcome Measures

Primary Outcomes (2)

Overall survival (OS)
Defined from the date of diagnosis to death from any cause. Patients alive at the end of follow-up or lost to follow-up are censored at the last contact time. The probability of remaining free of events at specific timepoints
To evaluate the Overall Survival at 12, 18, 24 and 36 months
Progression-free survival (PFS)
Defined from the diagnosis date to the date of investigator-determined disease relapse or death, whichever occurs first. The probability of remaining free of events at specific timepoints
To evaluate the Progression-free survival at 12, 18, 24 and 36 months

Secondary Outcomes (1)

Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).
From date of end of treatment until the date of last follow up, assessed up to 36 months

Study Arms (1)

Observational Study Group

Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1\>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression.

Drug: Durvalumab

Interventions

DurvalumabDrug

Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital

Also known as: Imfinzi

Observational Study 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 MethodNon-Probability Sample

Study Population

Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1\>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression.

You may qualify if:

Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).

Sponsors & Collaborators

Fundación GECP
Otherlead

Study Sites (22)

Complejo Hospitalario Universitario Del Ferrol

Ferrol, A Coruña, 15405, Spain

RECRUITING

Javier Afonso Afonso, MDCONTACT

Javier Afonso Afonso, MDPRINCIPAL INVESTIGATOR

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

Natividad Martínez-Banaclocha, MDCONTACT

Natividad Martínez-Banaclocha, MDPRINCIPAL INVESTIGATOR

Biospecimen

Retention: SAMPLES WITH DNA

Archival tumor samples Routine Blood samples extraction

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

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

Study Officials

Mariano Provencio, MD
Fundación GECP President
STUDY CHAIR

Central Study Contacts

Eva Pereira

CONTACT

+34934302006 gecp@gecp.org

Study Design

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

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 9, 2024

Study Start

October 3, 2024

Actual (reported)

Primary Completion

November 4, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Observational Study Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

Related Links

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Observational Study Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

Related Links

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations