RecruitingPhase 3NCT05522660

Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer

A Multicentre Randomised Open-label Phase III Study of Stereotactic Radiosurgery, in Addition to Standard Systemic Therapy for Patients With Metastatic Melanoma or Newly Diagnosed Metastatic NSCLC and Asymptomatic or Oligo-symptomatic Brain Metastases

Sponsor

ETOP IBCSG Partners Foundation

Enrollment

180 participants

Start Date

Nov 30, 2022

Study Type

INTERVENTIONAL

Summary

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. This proposed randomised phase III clinical study addresses one of the most controversial issues in the current approach to patients with brain mets: the timing of SRS in patients eligible for systemic immune checkpoint inhibition or targeted therapy in order to guide therapeutic options as to what strategy allows the best compromise between best survival and best QoL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether patients with brain metastases (cancer that has spread to the brain) from melanoma or non-small cell lung cancer should receive immunotherapy or targeted therapy alone, or whether adding focused radiation to the brain (stereotactic radiosurgery) improves outcomes. **You may be eligible if...** - You have 1–10 newly diagnosed brain metastases from melanoma or non-small cell lung cancer that have not been treated before (except for surgery) - At least one brain metastasis is 5 mm or larger - For 1–4 metastases, the largest one must be ≤30 mm - For 5–10 metastases, the largest must be ≤30 mm and ≤10 mL in volume - Your primary cancer has been confirmed by biopsy - You do not require high-dose steroids for more than one week **You may NOT be eligible if...** - You have more than 10 brain metastases - Your brain metastases are very large or the total volume is over 30 mL - You have severe neurological symptoms requiring high-dose steroids - Your primary cancer type is not melanoma or NSCLC Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic radiosurgery

Depending on the investigator's preference, the following standard of care fractionation schedules are recommended: 1x 18-22 Gy, 3x 9 Gy or 5x 6 Gy. Fractionated stereotactic radiotherapy is favoured in principle, but not mandated, for postoperative radiotherapy and for metastases with a diameter of \>20 mm or for \>4 brain metastases. For patients randomised to Arm A, radiotherapy should be initiated within 14 days after randomisation.

DRUGImmune checkpoint inhibitor

Systemic therapy follows the current standard of care, according to the type of the primary tumour. * For patients with melanoma, with or without BRAF-mutation, systemic therapy consists of * an approved immune-checkpoint inhibition combination therapy (cohort 1a) or * an approved immune-checkpoint inhibition monotherapy (cohort 1b). * For patients with NSCLC and a targetable oncogenic driver alteration (cohort 2a), systemic therapy consists of an approved targeted therapy (for example: EGFR-, ALK- or ROS1-targeted treatment). * For patients with NSCLC without a targetable oncogenic driver alteration (cohort 2b), systemic therapy consists of an approved immune-checkpoint inhibition therapy (with or without chemotherapy).

Locations(15)

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Naples, Italy

Instituto Oncologico Veneto IRCCS

Padova, Italy

Santa Maria della Misericordia Hospital

Perugia, Italy

Istituto Nazionale Tumori "Regina Elena"

Roma, Italy

Policlinico Umberto 1

Rome, Italy

Azienda ospedaliero-universitaria Senese Siena

Siena, Italy

NKI-AVL

Amsterdam, Netherlands

Vall Hebron Institute of Oncology (VHIO)

Barcelona, Spain

Hospital Puerta de Hierro

Majadahonda, Spain

Hospital La Fe

Valencia, Spain

Inselspital

Bern, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

Royal Marsden (Sutton)

London, United Kingdom

Christie NHS Manchester

Manchester, United Kingdom

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NCT05522660