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NCT07111104: ARIS
Survival Efficacy of Combined Radiotherapy and Immunotherapy in Patients With Metastatic Non-small Cell Lung Carcinoma
trial testing Immunotherapy in Non Small Cell Lung Cancer Metastatic in 350 participants. Completed in 28 April 2025.
14 October 2024
Quick facts
| Lead sponsor | Hopitaux Prives de Metz, Groupe UNEOS |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 350 |
| Start date | 14 October 2024 |
| Primary completion | 14 October 2024 |
| Estimated completion | 28 April 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Immunotherapy — full drug profile →
- Radiotherapy — full drug profile →
Conditions studied
- Non Small Cell Lung Cancer Metastatic — all drugs for Non Small Cell Lung Cancer Metastatic →
Sponsor
Hopitaux Prives de Metz, Groupe UNEOS
Who can join
18 and older, any sex, with Non Small Cell Lung Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07111104
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Non Small Cell Lung Cancer Metastatic
Currently open trials in the same condition.
- NCT06917573 — PALACE: Cemiplimab Trial According to ctDNA Levels · Phase 2 · recruiting
- NCT07190677 — First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial · recruiting
- NCT06473961 — A Phase Ib Study of GC101 in NSCLC · Phase 1 · recruiting
- NCT05864794 — Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer · NA · recruiting
- NCT05853887 — Liquid Biopsy Based NGS in Newly Diagnosed NSCLC · NA · active not recruiting
Other Hopitaux Prives de Metz, Groupe UNEOS trials
Trials by the same sponsor.
- NCT06597604 — Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07111104 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hopitaux Prives de Metz, Groupe UNEOS
- Last refreshed: 8 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07111104.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing