Durvalumab
DrugChemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital
Other names: Imfinzi
NCT Number: NCT06634199
Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Complejo Hospitalario Universitario Del Ferrol, Ferrol, A Coruña, Spain
The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital
Other names: Imfinzi
Time frame: To evaluate the Overall Survival at 12, 18, 24 and 36 months
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
Time frame: To evaluate the Progression-free survival at 12, 18, 24 and 36 months
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
Time frame: From date of end of treatment until the date of last follow up, assessed up to 36 months
Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS
Contact information is provided by the study sponsor or research team.
Fundación GECP
Other
Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA/B and IIIC NSCLC Patients Treated in Real World.
Acronym: SIENNA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05398094
Bronchial Neoplasms, Carcinoma, Bronchogenic
Alicante, Spain
View Trial DetailsNCT07104630
Bronchial Neoplasms, Carcinoma, Bronchogenic
Cleveland, Ohio, United States
View Trial DetailsNCT04716946
Bronchial Neoplasms, Carcinoma, Bronchogenic
Miami, Florida, United States
View Trial DetailsNCT06449313
Bronchial Neoplasms, Carcinoma, Bronchogenic
Washington D.C., District of Columbia, United States
View Trial Details