Immunotherapy and local treatments for patients with oligometastatic lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Centre François Baclesse
  Caen, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• Hospices Civils de Lyon (HCL)
  Lyon, France Recruiting
• CHU Nice
  Nice, France Recruiting

Study contacts

• Study coordinator: Antonin LEVY
• Email: antonin.levy@gustaveroussy.fr
• Phone: 01 42 11 47 57

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• NSCLC biomarker study using tumor and blood samples to link genetics with prognosis and immunotherapy response

  Researchers will test tumor tissue and blood from about 300 NSCLC patients to find genomic and immune markers that predict prognosis and response to immunotherapy.

  Recruiting at 20 sites Hellenic Cooperative Oncology Group · Limassol and 19 other locations · NCT07900581

• Wireless home prehabilitation for older adults with NSCLC awaiting lung surgery

  This study tests whether a personalized home exercise program guided by wearable devices can improve lung function for older NSCLC patients preparing for curative lung surgery.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07809763

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

• Targeted radioligand therapy for several solid tumors using DWJ155 imaging and treatment

  A phase 1 study tests [177Lu]Lu-DWJ155 for treatment and [68Ga]Ga-DWJ155 for imaging in adults with certain breast cancers, NSCLC, GEJ cancer, or bladder cancer who have not benefited from standard therapies.

  Recruiting at 6 sites Phase 1 Novartis · Omaha, Nebraska and 5 other locations · NCT07660055

• First-in-human imaging study of 68Ga-DFC413 and comparison with 68Ga-NNS309 in solid tumors

  This study tests a new radioactive imaging agent, 68Ga-DFC413, to see how it behaves in patients with several solid tumors and compares it to 68Ga-NNS309.

  Recruiting at 2 sites Phase 1 Novartis · Odense C and 1 other locations · NCT07630961

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.