Clinical trial · Observational
Survival Efficacy of Combined Radiotherapy and Immunotherapy in Patients With Metastatic Non-small Cell Lung Carcinoma
Survival Efficacy of Combined Radiotherapy and Immunotherapy in Patients With Metastatic Non-small Cell Lung Carcinoma: an Observational Retrospective Multicenter Study
- 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)
The aim of this retrospective, multicenter, observational study is to evaluate the potential clinical benefit of adding radiotherapy (administered either concomitantly or sequentially) to immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC). One promising approach involves the integration of radiotherapy into the treatment plan. Radiotherapy is known not only for its cytotoxic local effects, but also for its ability to modulate the tumor microenvironment, increase antigen presentation, and stimulate systemic immune responses. This study will compare two cohorts of patients with metastatic NSCLC treated in real-world clinical settings. The first cohort includes patients treated with immunotherapy alone, while the second includes those who received immunotherapy in combination with radiotherapy. Radiotherapy may have been administered concurrently or sequentially with respect to immunotherapy, based on clinical judgment. The primary objective is to determine whether the addition of radiotherapy improves progression-free survival (PFS) by at least 30%, compared to immunotherapy alone. This threshold reflects clinically meaningful differences reported in randomized controlled trials in similar populations and treatment lines. Secondary objectives include overall survival (OS) and exploring predictive factors of treatment response, such as patient demographics, tumor characteristics, mutational status, timing of radiotherapy and abscopal effect evaluation, to refine patient selection for future combination strategies. Eligible participants are adults with histologically confirmed metastatic NSCLC, treated with first-line or second-line immunotherapy, and with no prior exposure to immunotherapy. Data will be retrospectively collected from medical records, and treatment arms will be assigned based on actual clinical care paths. Participants will: * Be retrospectively identified from hospital records. * Be assigned to one of two cohorts: immunotherapy alone or immunotherapy + radiotherapy (concomitant or sequential). * Have their data analyzed for OS, PFS, toxicity, and potential predictive biomarkers. The results of this study will contribute to a better understanding of real-world outcomes in metastatic NSCLC patients and may inform future prospective trials evaluating radiotherapy as a modulator of immunotherapy efficacy.
Conditions
Conditions (1)
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 Metastatic | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Immunotherapy cohort
- description
- This group includes patients with metastatic non small cell lung cancer (NSCLC) who received immune checkpoints inhibitors (Nivolumab, Atezolizumab or Pembrolizumab) without any associated radiotherapy during the course of treatment
- interventionNames
- Drug: Immunotherapy
- label
- Immunotherapy + radiotherapy cohort
- description
- This group includes patients with metastatic non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitors (Nivolumab, Atezolizumab, or Pembrolizumab) in combination with radiotherapy. Radiotherapy was delivered either concomitantly or sequentially to immunotherapy.
- interventionNames
- Drug: Immunotherapy
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Patient with metastatic non-small cell cancer who has received one line of immunotherapy (PEMBROLIZUMAB, ATEZOLIZUMAB and NIVOLUMAB) in stage IV. * Disease evaluable according to iRECIST v1.1 criteria * For previously irradiated patients, a non-irradiated lesion evaluable according to iRECIST * WHO (World Health Organization) score less than or equal to 2. Exclusion Criteria: * Composite cancer, small cell lung cancer * Not metastatic at the time of immunotherapy * Has already received one line of immunotherapy for non-small cell lung cancer: antibody against Programmed cell Death protein 1 (anti-PD-1), antibody against Programmed Death-Ligand 1 or 2 (anti-PD-L1 and anti-PD-L2), antiboby against Cluster of Differentiation 137 (anti-CD137), antibody against Cytotoxic T-lymphocyte-antigen-4 (anti-CTLA-4)) . * Second active cancer under treatment * Immunotherapy for another cancer * Withdrawal of consent Non inclusion Criteria: \- Patients treated with DURVALUMAB, on the basis of its marketing authorisation in non-small cell lung cancer and in the adjuvant treatment of NSCLC treated with concomitant radiochemotherapy.
References
Publications (0)
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