Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
juin 2025
février 2030
14 septembre 2025
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antonin LÉVY, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Sainte-Catherine - 84000 - Avignon - Provence-Alpes-Côte d'Azur - France | Nicolas POUREL, MD | Contact (sur clinicalTrials) | |||
| Institut de Radiothérapie du Sud de l'Oise - 60100 - Creil - Hauts-de-France - France | Andres HUERTAS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Histologically proven advanced synchronous oligometastatic stage IV NSCLC.
- NSCLC patients eligible first line immunotherapy-based SoC according to the European
Marketing Authorization.
- PDL1 status available.
- Metastases eligible to RLT according to the local multidisciplinary board (MTB):
≤5cm each in CT scan, excluding primary tumour.
- Maximum 5 metastases in 3 organs (EORTC criteria), according to brain MRI and
FDG-PET.
- Symptomatic lesions requiring urgent palliative radiation, is permitted prior to
randomization. These treated lesions should be counted towards the total number of
metastases at the time of enrolment.
- Clinically required brain metastases (BM) ablation (surgery and/or SBRT) is
permitted and BM count within the total number of 5 lesions. The patient would then
be randomized to treatment of their extracranial disease.
- Acceptable organ function for RLT.
- ECOG performance status (PS) 0-1.
- Measurable lesions according to RECIST V1.1 on standard imaging.
- Patient aged 18 or more.
- Woman of childbearing potential must agree to use adequate contraception (implant
type, vaginal ring, contraceptive pill, contraceptive patch, Intrauterine Device
(IUD), etc.) for the duration of study participation and up to 6 months after
completing treatment/therapy, in addition, male partners use a condom during this
same period. Male patients must agree to use condom for the duration of study
participation and up to 6 months after completing treatment/therapy.
- Patients affiliated to the social security system.
- Patient should understand, sign, and date the informed consent form written in
French prior to any protocol-specific procedures performed.
- Patient is willing and able to comply with the protocol for the duration of the
study including undergoing treatment and scheduled visits, and examinations
including follow-up.
- Histologically proven advanced synchronous oligometastatic stage IV NSCLC.
- NSCLC patients eligible first line immunotherapy-based SoC according to the European
Marketing Authorization.
- PDL1 status available.
- Metastases eligible to RLT according to the local multidisciplinary board (MTB):
≤5cm each in CT scan, excluding primary tumour.
- Maximum 5 metastases in 3 organs (EORTC criteria), according to brain MRI and
FDG-PET.
- Symptomatic lesions requiring urgent palliative radiation, is permitted prior to
randomization. These treated lesions should be counted towards the total number of
metastases at the time of enrolment.
- Clinically required brain metastases (BM) ablation (surgery and/or SBRT) is
permitted and BM count within the total number of 5 lesions. The patient would then
be randomized to treatment of their extracranial disease.
- Acceptable organ function for RLT.
- ECOG performance status (PS) 0-1.
- Measurable lesions according to RECIST V1.1 on standard imaging.
- Patient aged 18 or more.
- Woman of childbearing potential must agree to use adequate contraception (implant
type, vaginal ring, contraceptive pill, contraceptive patch, Intrauterine Device
(IUD), etc.) for the duration of study participation and up to 6 months after
completing treatment/therapy, in addition, male partners use a condom during this
same period. Male patients must agree to use condom for the duration of study
participation and up to 6 months after completing treatment/therapy.
- Patients affiliated to the social security system.
- Patient should understand, sign, and date the informed consent form written in
French prior to any protocol-specific procedures performed.
- Patient is willing and able to comply with the protocol for the duration of the
study including undergoing treatment and scheduled visits, and examinations
including follow-up.
- Non-squamous NSCLC with targetable tumour mutations and approved first line targeted
therapy (such as EGFR, ALK and ROS1).
- Metastases not eligible to RLT: e.g. brainstem or diffuse serosal metastases
(meningeal, pericardial, pleural, peritoneal, mesenteric) or that invades the
gastrointestinal tract.
- Brain metastases only, without extra-cerebral metastases.
- Uncontrolled severe comorbidity, symptomatic interstitial lung disease or active
infection.
- Prior therapy with T-cell costimulation or immune checkpoint-targeted agents within
1 year.
- Uncontrolled concomitant (<1-year) malignancy except adequately treated basal or
squamous cell carcinoma of the skin, or in-situ carcinoma of any organ or in-situ
melanoma of the skin.
- Persons deprived of liberty by judicial or administrative decision.
- Persons subject to a legal protection measure (guardianship, curatorship, safeguard
of justice).
- Persons not affiliated to a social security system or equivalent.