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Survival Efficacy of Combined Radiotherapy and Immunotherapy in Patients With Metastatic Non-small Cell Lung Carcinoma

NCT07111104 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-08-08

No results posted yet for this study

Summary

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

  • Non Small Cell Lung Cancer Metastatic

Interventions

DRUG

Immunotherapy

The immunotherapy intervention consists of treatment with immune checkpoint inhibitors, specifically Nivolumab (OPDIVO), Atezolizumab (TECENTRIQ), Pembrolizumab (KEYTRUDA). These drugs are monoclonal antibodies that block PD-1 or PD-L1 pathways, aiming to enhance the immune system's ability to recognize and destroy cancer cells. The treatment is administered intravenously according to standard dosing schedules.

RADIATION

Radiotherapy

The radiotherapy intervention involves targeted delivery of ionizing radiation to metastatic lesions. Radiotherapy may be given either concurrently with immunotherapy or sequentially afterward, depending on the patient's treatment plan. The purpose is to achieve local tumor control and potentially enhance the systemic immune response through immunogenic cell death. Different radiation techniques and dose regimens may be employed based on lesion size, location, and clinical considerations.

Sponsors & Collaborators

  • Hopitaux Prives de Metz, Groupe UNEOS

    lead OTHER

Principal Investigators

  • Ariane Guignard, Resident · Hopitaux privés de Metz - UNEOS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2024-10-14
Completion
2025-04-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111104 on ClinicalTrials.gov