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New treatment option for Non-Small Cell Lung Cancer
Official title Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05522660
What this study is testing
What is Immune checkpoint inhibitor?
Immune checkpoint inhibitor is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as standard of care treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of the study is to assess the efficacy in terms of CNS-specific PFS of the combination of standard systemic treatment plus SRS vs. standard systemic treatment alone in patients with newly diagnosed and untreated (except for surgery) asymptomatic or oligosymptomatic brain metastases from melanoma or NSCLC.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Most important
- Newly diagnosed, previously untreated (except for surgery, see below) asymptomatic or oligo-symptomatic brain metastases, e.g., controlled...
- Requirements for brain metastases:
- Brain metastases must be previously untreated, except for surgery.
- Prior surgery (including biopsies, resection, and cyst aspiration) for brain metastases is allowed. Residual and measurable disease after surgery is...
You likely can't join if
- Confirmed or probable leptomeningeal metastases according to EANO ESMO criteria
- Symptomatic brain metastases at time of randomisation, e.g., neurological symptoms or signs that require more than a stable dose of 4 mg...
- Patients must be off steroids or on a stable dose of ≤4 mg dexamethasone equivalent at randomisation.
- Patients experiencing seizures controlled by anti-epileptic drugs are eligible.
- Prior whole brain irradiation or focal radiation therapy to the brain
- Prior systemic treatment for brain metastases
See the full eligibility criteria
- Most important
- Newly diagnosed, previously untreated (except for surgery, see below) asymptomatic or oligo-symptomatic brain metastases, e.g., controlled symptomatic seizure disorder. Note: patients with neurological symptoms or signs...
- Requirements for brain metastases:
- Brain metastases must be previously untreated, except for surgery.
- Prior surgery (including biopsies, resection, and cyst aspiration) for brain metastases is allowed. Residual and measurable disease after surgery is not required, but surgery must have confirmed the diagnosis. An MRI...
- Number and size of metastases at diagnosis of brain metastases:
- Maximum 1-10 brain metastases at screening
- At least one brain metastasis must be of ≥5 mm in diameter
- In case of 1-4 brain metastases:
- Longest diameter of largest brain metastasis must be ≤30 mm
- In case of 5-10 brain metastases:
- Largest metastasis must be ≤10 mL in volume and longest diameter must be ≤30 mm
- Maximum cumulative brain metastases volume must be ≤30 mL
- Primary disease of histologically confirmed (from primary tumour or from a metastatic lesion, including in the brain) melanoma or NSCLC
- Requirements for patients with melanoma:
- Prior treatment, including treatment with immune-checkpoint inhibitors is permitted, but brain metastases must be newly diagnosed and previously untreated (except for surgery).
- BRAF-mutation status, locally assessed, should be known (previous adjuvant BRAF-targeted therapy is allowed).
- Requirements for patients with NSCLC:
- Newly diagnosed, treatment-naïve (except for prior surgery) metastatic NSCLC, with or without a targetable oncogenic driver alteration.
- Known PD-L1 expression status (from primary tumour or from a metastatic lesion, including brain)
- Known driver mutation status (from primary tumour or from a metastatic lesion, including brain).
- Age of 18 years or older
- Karnofsky performance status of 60 or more
- Life expectancy \>12 weeks
- Patients must be candidates for systemic treatment, within the defined cohorts (melanoma: cohorts 1a and 1b; NSCLC: cohorts 2a and 2b).
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 7 days before randomisation.
- Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention. Most important
- Confirmed or probable leptomeningeal metastases according to EANO ESMO criteria
- Symptomatic brain metastases at time of randomisation, e.g., neurological symptoms or signs that require more than a stable dose of 4 mg dexamethasone equivalent for more than one week.
- Patients must be off steroids or on a stable dose of ≤4 mg dexamethasone equivalent at randomisation.
- Patients experiencing seizures controlled by anti-epileptic drugs are eligible.
- Prior whole brain irradiation or focal radiation therapy to the brain
- Prior systemic treatment for brain metastases
- Contra-indication for SRS
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Women who are pregnant or in the period of lactation.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
- Padova, Italy
- Perugia, Italy
- Roma, Italy
- Rome, Italy
- Siena, Italy
- Amsterdam, Netherlands
- Barcelona, Spain
- Majadahonda, Spain
- Valencia, Spain
- Bern, Switzerland
- Winterthur, Switzerland
- Zurich, Switzerland
- London, United Kingdom
- Manchester, United Kingdom
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 - 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy; Padova, Italy; Perugia, Italy; Roma, Italy; Rome, Italy; Siena, Italy and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.