Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación GECP
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
ECOG 0-1.
PDL1>1%.
Age ≥ 18 years at time of study
Disqualifiers
Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
No possibility of venipuncture
Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Durvalumab
DrugChemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Observational Study Group1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
To evaluate the Overall Survival at 12, 18, 24 and 36 months2
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
Time frame
To evaluate the Progression-free survival at 12, 18, 24 and 36 monthsSecondary outcomes
1
Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).
Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS
Time frame
From date of end of treatment until the date of last follow up, assessed up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov