A randomized study to comparelomustine with lomustine and bevacizumab for patients with recurrent malignant brain tumors.

A randomized phase III trial with lomustine versus lomustine and bevacizumab for patients with recurrent glioblastoma. - DNOG-LOBE-01

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003545-11-DK

Enrollment

168

Registered

2020-08-27

Start date

2020-12-16

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrent glioblastoma MedDRA version: 20.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: lomustine Product Name: lomustine Pharmaceutical Form: Capsule INN or Proposed INN: lomustine Other descriptive name: LOMUSTINE Concentration unit: mg milligram(s) Concentration type: up t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histological verified glioblastoma • Recurrent GBM, previously treated according the STUPP regimen • PS 0-1 • Age > 18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

Exclusion criteria: • Previous therapy of recurrent GBM including temozolomide reinduction. • Previous use of biological drug targeting the VEGF-signaling pathway

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether bevacizumab increases survival when added to lomustine as compared to lomustine alone in patients with recurrent GBM;Secondary Objective: Safety of bevacizumab when added to lomustine as compared to lomustine alone in patients with recurrent GBM;Primary end point(s): 1) The primary endpoint is overall survival. ;Timepoint(s) of evaluation of this end point: at least 12 months of follow up	—

Measure

Time frame

Main Objective: To determine whether bevacizumab increases survival when added to lomustine as compared to lomustine alone in patients with recurrent GBM;Secondary Objective: Safety of bevacizumab when added to lomustine as compared to lomustine alone in patients with recurrent GBM;Primary end point(s): 1) The primary endpoint is overall survival. ;Timepoint(s) of evaluation of this end point: at least 12 months of follow up

—

Secondary

Measure	Time frame
Secondary end point(s): 1) To determine the 6- and 12 months progression-free survival (PFS) 2) To determine the objective response rate (RR) and duration of response (according to RANO criteria). 3) To determine the overall survival distribution and overall survival at 12 and 18 months. 4) To determine the safety and feasibility of the combination of bevacizumab and lomustine as compared to lomustine alone. ;Timepoint(s) of evaluation of this end point: 6 and 12 month	—

Measure

Time frame

Secondary end point(s): 1) To determine the 6- and 12 months progression-free survival (PFS) 2) To determine the objective response rate (RR) and duration of response (according to RANO criteria). 3) To determine the overall survival distribution and overall survival at 12 and 18 months. 4) To determine the safety and feasibility of the combination of bevacizumab and lomustine as compared to lomustine alone. ;Timepoint(s) of evaluation of this end point: 6 and 12 month

—

Countries

Denmark

Contacts

Public ContactUlrik Lassen

Rigshospitalet

ulrik.lassen@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026