Clinical trial · Observational
Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| PDL1 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Observational Study Group
- description
- 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.
- interventionNames
- Drug: Durvalumab
Primary outcomes (2)
- measure
- Overall survival (OS)
- timeFrame
- To evaluate the Overall Survival at 12, 18, 24 and 36 months
- description
- 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
- measure
- Progression-free survival (PFS)
- timeFrame
- To evaluate the Progression-free survival at 12, 18, 24 and 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available