Actively Recruiting
First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients.
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-09-15
124
Participants Needed
3
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced synchronous oligometastatic stage IV NSCLC
- Eligible for first-line immunotherapy-based standard of care as per European Marketing Authorization
- PD-L1 status available
- Metastases suitable for radical local treatment, each 645 cm on CT scan, excluding primary tumor
- Maximum of 5 metastases in up to 3 organs confirmed by brain MRI and FDG-PET
- Symptomatic lesions needing urgent palliative radiation allowed before randomization and counted in total metastases
- Brain metastases ablation allowed if clinically required and counted within total 5 lesions
- Acceptable organ function for radical local treatment
- ECOG performance status 0-1
- Measurable lesions according to RECIST V1.1 on imaging
- Age 18 years or older
- Women of childbearing potential must use effective contraception during and 6 months after study; male partners must use condoms during same period
- Male patients must use condoms during study and 6 months after
- Affiliated with social security system
- Able to understand, sign, and date informed consent in French before any study procedures
- Willing and able to comply with study protocol, treatments, visits, and follow-up
You will not qualify if you...
- Non-squamous NSCLC with targetable tumor mutations and approved first-line targeted therapy (e.g., EGFR, ALK, ROS1)
- Metastases not eligible for radical local treatment, including brainstem or diffuse serosal metastases or those invading the gastrointestinal tract
- Brain metastases only without extracerebral metastases
- Uncontrolled severe comorbidities, symptomatic interstitial lung disease, or active infection
- Prior therapy with T-cell costimulation or immune checkpoint agents within 1 year
- Uncontrolled malignancy within 1 year except treated basal or squamous cell skin carcinoma, in-situ carcinoma, or in-situ melanoma
- Persons deprived of liberty by judicial or administrative decision
- Persons under legal protection measures such as guardianship or curatorship
- Persons not affiliated with a social security system or equivalent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Institut de Radiothérapie du Sud de l'Oise
Creil, Hauts-de-France, France, 60100
Actively Recruiting
2
Centre Sainte-Catherine
Avignon, Provence-Alpes-Côte d'Azur Region, France, 84000
Actively Recruiting
3
Gustave Roussy
Villejuif, Île-de-France Region, France, 94805
Actively Recruiting
Research Team
A
Antonin LÉVY, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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