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

PHASE3RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 30, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

December 31, 2026

Conditions
Non-Small Cell Lung CancerMelanoma
Interventions
RADIATION

Stereotactic 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."

DRUG

Immune 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)."

Trial Locations (15)

Unknown

NOT_YET_RECRUITING

"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale", Napoli

NOT_YET_RECRUITING

Instituto Oncologico Veneto IRCCS, Padua

RECRUITING

Santa Maria della Misericordia Hospital, Perugia

RECRUITING

"Istituto Nazionale Tumori Regina Elena", Roma

RECRUITING

Policlinico Umberto 1, Rome

RECRUITING

Azienda ospedaliero-universitaria Senese Siena, Siena

RECRUITING

NKI-AVL, Amsterdam

RECRUITING

Vall Hebron Institute of Oncology (VHIO), Barcelona

RECRUITING

Hospital Puerta de Hierro, Majadahonda

RECRUITING

Hospital La Fe, Valencia

RECRUITING

Inselspital, Bern

RECRUITING

Kantonsspital Winterthur, Winterthur

RECRUITING

Universitätsspital Zürich, Zurich

RECRUITING

Royal Marsden (Sutton), London

RECRUITING

Christie NHS Manchester, Manchester

All Listed Sponsors
collaborator

USZ Foundation

UNKNOWN

lead

ETOP IBCSG Partners Foundation

NETWORK