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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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.
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).
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Napoli, Italy
RECRUITINGInstituto Oncologico Veneto IRCCS
Padua, Italy
NOT_YET_RECRUITINGSanta Maria della Misericordia Hospital
Perugia, Italy
RECRUITINGIstituto Nazionale Tumori "Regina Elena"
Roma, Italy
RECRUITINGPoliclinico Umberto 1
Rome, Italy
RECRUITINGAzienda ospedaliero-universitaria Senese Siena
Siena, Italy
RECRUITINGNKI-AVL
Amsterdam, Netherlands
RECRUITINGVall Hebron Institute of Oncology (VHIO)
Barcelona, Spain
RECRUITINGHospital Puerta de Hierro
Majadahonda, Spain
RECRUITINGHospital La Fe
Valencia, Spain
RECRUITING...and 5 more locations
CNS-specific PFS, locally assessed as per iRANO criteria
The primary objective of the study is to assess the efficacy in terms of CNS-specific progression-free survival (PFS) of the combination of standard systemic treatment plus SRS versus standard systemic treatment alone in patients with newly diagnosed and untreated (except surgery) asymptomatic or oligo-symptomatic brain metastases from melanoma or non-small cell lung cancer, with indication for systemic therapy.
Time frame: from date of randomization until the date of documented CNS-specific progression, assessed up to 42 months
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