Immunotherapy and local treatments for patients with oligometastatic lung cancer
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
This study is testing if combining immunotherapy with local treatments can help people with a few spots of lung cancer feel better compared to standard treatments alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 3 sites (Creil, Hauts-de-France and 2 other locations) |
| Trial ID | NCT06840782 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial investigates the effectiveness of first-line immunotherapy combined with local ablative treatments for patients diagnosed with oligometastatic non-small cell lung cancer (NSCLC). The study is randomized and multicenter, focusing on patients with a limited number of metastases who are eligible for standard immunotherapy. Participants will receive radical local treatment alongside standard of care immunotherapy, with the potential addition of chemotherapy. The goal is to evaluate the impact of this combined approach on patient outcomes compared to standard treatments alone.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed oligometastatic stage IV NSCLC who meet specific criteria for immunotherapy and local treatment eligibility.
Not a fit: Patients with extensive metastases beyond the eligibility criteria or those not suitable for immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with oligometastatic NSCLC.
How similar studies have performed: Previous studies have shown promising results with similar immunotherapy and local treatment combinations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: * 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.
Where this trial is running
Creil, Hauts-de-France and 2 other locations
- Institut de Radiothérapie du Sud de l'Oise — Creil, Hauts-de-France, France (Recruiting)
- Centre Sainte-Catherine — Avignon, Provence-Alpes-Côte d'Azur Region, France (Recruiting)
- Gustave Roussy — Villejuif, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Antonin LÉVY, MD
- Email: antonin.levy@gustaveroussy.fr
- Phone: +33 (0)1 42 11 47 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.