Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Understanding response to stereotactic body radiotherapy in early-stage lung cancer

Official title: MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer

Run by European Institute of Oncology · NCT05974475 · Data updated 2026-11-12

This study is trying to understand why some people with early-stage lung cancer respond better to a specific type of radiation treatment than others, to help improve future treatments.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment270 (estimated)
SponsorEuropean Institute of Oncology
Academic / other
Drugs / interventionsradiation
Locations2 sites (Milan, Italy and 1 other locations)
StatusRecruiting
StartedSeptember 11, 2023
Main results expectedSeptember 2026
Study endsSeptember 2028
Registry record updatedSeptember 23, 2024
Trial IDNCT05974475 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with histologically proven early-stage non-small cell lung cancer who are eligible for SBRT and have an ECOG performance status of 0-1.

Probably not a fit

Patients with prior invasive cancer diagnoses within the last three years or those with severe comorbidities that contraindicate SBRT may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational trial aims to investigate the factors influencing the response of early-stage non-small cell lung cancer (NSCLC) patients to stereotactic body radiotherapy (SBRT). It will collect clinical, imaging, and biological data to develop models that predict treatment outcomes. The study includes tasks such as analyzing routine clinical data, performing quantitative imaging analysis, and conducting gene expression and proteomics studies. The goal is to identify why some patients respond well to SBRT while others do not, potentially leading to improved treatment strategies.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict which patients will benefit from SBRT, leading to more personalized treatment approaches.

How similar studies have gone: Other studies have shown promise in using multi-omics approaches to understand cancer treatment responses, suggesting this methodology could be beneficial.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Histologically proven NSCLC; all histologies will be considered eligible (e.g. squamous, adenocarcinoma, large cell carcinoma);
* American Joint Committee on Cancer Tumor Node Metastasis (AJCC TNM) classification (8th Edition) clinical stage I-II;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* No absolute contraindications to either surgery (e.g. severe comorbidities) or SBRT (e.g. active connective diseases, severe pulmonary fibrosis);
* Ability and willingness to sign a written informed consent for treatment and study participation.

Exclusion Criteria:

* Prior diagnosis of invasive cancer (within 3 years before the diagnosis of ES-NSCLC);
* Mental diseases or psychiatric disorders preventing the acquisition of a valid informed consent.

Where it's running

  • Istituto Europeo di Oncologia IRCCS
    Milan, Italy, Italy
    Recruiting
  • Istituto Europeo di Oncologia (IEO) IRCCS
    Milan, Lombardy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.