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LUMOS2

Trial status: Open

Summary

LUMOS2 is an innovative umbrella trial to address the unmet needs of people with relapsed G2/3 IDH-mutant glioma. Allocation to LUMOS2 treatment arms will be guided by genomic profiling results. Participants with a matched, targeted therapy will be provided the therapy through a LUMOS2 targeted treatment arm and participants who do not have an actionable molecular target, will be randomly allocated to a LUMOS2 treatment arm with a novel mechanism of action.

Each treatment arm will recruit 19 patients and the primary objective of the study is to determine progression-free survival at six months.

Study Chair

Professor Hui Gan

Coordinating Centre

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: lumos2.study@sydney.edu.au

Design

Multi-arm, phase 2, biomarker-directed, signal-seeking, umbrella clinical trial

Cancer Type

Relapsed Grade 2/3 IDH-mutant glioma

Intervention

Arm 1 – Paxalisib: 45mg taken orally (capsule), once daily, for a 28 day cycle. If tolerated, after cycle 1 this will increase to 60mg daily.
Arm 2 – AK104: 6mg/kg as Intravenous injection, once every 2 weeks
Arm 3 – Selinexor: 80mg taken orally (tablet), once weekly
Arm 4 – Auceliciclib (currently on hold)
Arm 5 – PICCOG arm: Niraparib and AK104: Niraparib: 200mg daily taken orally (tablet), for a maximum of 3 cycles (each cycle is 28 days), AK104: 6mg/kg as Intravenous injection, once every 2 weeks. AK104 and Niraparib is taken simultaneously in combination.

Publications

Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2): study protocol for a phase 2, prospective, multicentre, open-label, multiarm, biomarker-directed, signal-seeking, umbrella, clinical trial for recurrent IDH mutant, grade 2/3 glioma

Kristen McParland, Eng-Siew Koh, Benjamin Kong, Hao-Wen Sim, Subotheni Thavaneswaran, Sonia Yip, Elizabeth H Barnes, Mandy L Ballinger, David M Thomas, Richard De Abreu Lourenco, John Simes, Lucille Sebastian, Patrick J Wheeler, Desma Spyridopoulos, Cynthia Hawkins, Marshall Pitz, Christopher O’Callaghan, Hui K Gan
BMJ Open 2025;15:e087922.
https://doi.org/10.1136/bmjopen-2024-087922.

Date of activation:

Expected final accrual date:

Purpose of the study

ELIGIBILITY CRITERIA

Inclusion Criteria

Exclusion Criteria

Patient population

Primary outcome

Intervention

Arm 1 – Paxalisib: 45mg taken orally (capsule), once daily, for a 28 day cycle. If tolerated, after cycle 1 this will increase to 60mg daily.
Arm 2 – AK104: 6mg/kg as Intravenous injection, once every 2 weeks
Arm 3 – Selinexor: 80mg taken orally (tablet), once weekly
Arm 4 – Auceliciclib (currently on hold)
Arm 5 – PICCOG arm: Niraparib and AK104: Niraparib: 200mg daily taken orally (tablet), for a maximum of 3 cycles (each cycle is 28 days), AK104: 6mg/kg as Intravenous injection, once every 2 weeks. AK104 and Niraparib is taken simultaneously in combination.

Secondary outcome

20 Participating Sites

76 Recruitment Target

Additional Information
Contact Email

Trial Locations

VIC

Location:

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia

Trials & Research

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