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 (OliGRAIL)

Trial details

Who runs it

Institut Gustave Roussy

Trial code

EU 2023-503326-39-00

Record updated

2026. április 9.

Original description

To demonstrate the survival benefit of adding a radical local treatment (RLT) on a maximum of 5 secondary lesions in non-small cell lung cancer (NSCLC) patients receiving standard of care (SoC)-based immunotherapRead full original descriptionShow less

To demonstrate the survival benefit of adding a radical local treatment (RLT) on a maximum of 5 secondary lesions in non-small cell lung cancer (NSCLC) patients receiving standard of care (SoC)-based immunotherap

Inclusion: Histologically proven advanced oligometastatic stage IV NSCLC; 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 remaining disease; Acceptable organ function for RLT; ECOG performance status (PS) 0-1; Measurable lesions according to RECIST V1.1 or evaluable disease on standard imaging,; Patient should understand, sign, and date the informed consent form written in French prior to any protocol-specific procedures performed; Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 6 months after completing treatment/therapy; Patients affiliated to the social security system; 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; Aga > 18 years; NSCLC patients eligible first line immunotherapy-based SoC according to the European Marketing Authorization. PDL1 status available; Metastases eligible to RLT(minimally invasive surgery, SBRT and/or interventional radiology) 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.

Exclusion: 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; Uncontrolled severe comorbidity, including but not limited to symptomatic interstitial lung disease or active infection; 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.

EU CTIS 2023-503326-39-00