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)
EU CTIS ID: 2023-503326-39-00
What this study is testing
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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,
You likely can't join if
- 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.
- Uncontrolled severe comorbidity, including but not limited to 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.
See the full eligibility criteria
- 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
- 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.
- Uncontrolled severe comorbidity, including but not limited to 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.
The study team makes the final eligibility decision.
Where it's taking place
- France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.