RecruitingPhase 3NCT06840782

First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients.

First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients: a Randomized, Multicentre, Open-label Phase III Study


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

124 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

First-line immunotherapy-based standard of care and local ablative treatments for oligometastatic non-small cell lung cancer patients: a randomized, multicentre, open-label phase III study


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted radiation therapy (called radical local treatment, or RLT) to standard immunotherapy improves outcomes for people with stage IV non-small cell lung cancer (NSCLC) that has spread to only a few locations (called oligometastatic disease). Standard care uses immunotherapy alone; this trial adds precision radiation to the metastases. **You may be eligible if...** - You have been diagnosed with stage IV NSCLC that has spread to 5 or fewer sites in 3 or fewer organs - Your cancer is eligible for first-line immunotherapy according to European guidelines - Your metastases are each 5 cm or smaller and safely treatable with radiation - You have had a PD-L1 test done on your tumor **You may NOT be eligible if...** - You have more than 5 metastatic sites - Your tumor is not suitable for immunotherapy - You have had previous systemic treatment for advanced NSCLC - You have certain serious health conditions that would make radiation or immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadical local treatment

RLT of all metastatic sites. The possible RLT options will be SBRT, interventional radiology and/or minimally invasive surgery. Depending on the metastatic site, access and patient condition, the best RLT should be initially discussed in a case-to-case basis at the local multidisciplinary board (MTB). The primary tumour and initially invaded lymph nodes should be treated during the maintenance phase. Curative-intent approach modalities (e.g. hypofractionated intensity-modulated thoracic radiation therapy or surgery) should be discussed at the local MTB.

DRUGSoC-based immunotherapy (+/- chemotherapy)

Current French SoC will be used. Main SoC-based immunotherapy includes: * Platinum-based chemotherapy combined with an anti PD-1 immunotherapy (pembrolizumab). Pemetrexed-platinum combinations may be used in non- squamous carcinoma, while paclitaxel-platinum combination is favoured in squamous carcinoma. * Anti PD-1 monotherapy if PD-L1 ≥ 50% is a possible alternative (pembrolizumab or atezolizumab or cemiplimab). Other alternatives include nivolumab-ipilimumab-chemotherapy or durvalumab-tremelimumab-chemotherapy association. Bevacizumab is not allowed given possible interactions with RLT. Maintenance/Immunotherapy alone will be pursued at the investigator's discretion according to the standard procedures (toxicity, progression, choice of the patient...).


Locations(3)

Institut de Radiothérapie du Sud de l'Oise

Creil, Hauts-de-France, France

Centre Sainte-Catherine

Avignon, Provence-Alpes-Côte d'Azur Region, France

Gustave Roussy

Villejuif, Île-de-France Region, France

View Full Details on ClinicalTrials.gov

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NCT06840782