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

Phase 3

Recruiting

• Conditions: Non-Small Cell Lung Cancer; Melanoma
• Interventions: Radiation: Stereotactic radiosurgery; Drug: Immune checkpoint inhibitor

• Registration Number: NCT05522660
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-08-31
• Study Start: 2022-11-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard systemic treatment with stereotactic radiosurgery (SRS)	Stereotactic radiosurgery	Arm A
Standard systemic treatment with stereotactic radiosurgery (SRS)	Immune checkpoint inhibitor	Arm A
Standard systemic treatment without stereotactic radiosurgery	Immune checkpoint inhibitor	Arm B

Primary Outcome Measures

Name	Time	Method
CNS-specific PFS, locally assessed as per iRANO criteria	from date of randomization until the date of documented CNS-specific progression, assessed up to 42 months	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.

Trial Locations

Locations (15)

Instituto Oncologico Veneto IRCCS; 🇮🇹 Padova, Italy

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"; 🇮🇹 Napoli, 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

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