Non-small Cell Lung Cancer Stage III, PDL1 Gene Mutation
Conditions
Keywords
Lung Cancer, Chemo radiotherapy, ctDNA, Inmunotherapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGDurvalumab
Chemo-radiotherapy + Durvalumab for non-resectable stage III NSCLC patients according to clinical practice of each participant hospital
Sponsors
Fundación GECP
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice * Patient capable of proper therapeutic compliance and accessible for correct follow-up. * Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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 |
| Progression-free survival (PFS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Association between the baseline ctDNA and ctDNA clearance with each one of the OS or PFS |
Countries
Spain
Contacts
CONTACTEva Pereira
STUDY_CHAIRMariano Provencio, MD
Fundación GECP President
Outcome results
None listed