Clinical Trial Intelligence

Which endpoints are most frequently measured in European Phase II and III glioblastoma and glioma clinical trials?

9 July 2026

Across 71 unique CTIS/EU Phase II–III glioblastoma and glioma trials, quality of life / patient-reported outcomes were the most frequently measured endpoint family, appearing in 50/71 trials (70.4%). Progression-free survival and safety followed at 47/71 each (66.2%), while objective response, imaging/RANO-RAPNO assessment, and overall survival each appeared in 46/71 trials (64.8%). Primary endpoints were led by QoL/PRO (28/71, 39.4%) and overall survival (27/71, 38.0%); secondary endpoints were led by QoL/PRO (47/71, 66.2%) and objective response (42/71, 59.2%).

Included trials
71
Unique CTIS/EU Phase II–III trials
Top endpoint
70.4%
QoL/PRO in 50/71 trials
Next tier
66.2%
PFS and safety, each 47/71
CTIS timing
52 days
Median initial submission to first authorization

QoL/PRO, PFS, safety, response, imaging, and OS form the dominant endpoint core

Six endpoint families appeared in at least 46/71 trials (64.8%): QoL/PRO, progression-free survival, safety, objective response, imaging/RANO-RAPNO assessment, and overall survival.

Trial-level endpoint presence, n=71
Quality of life / PRO70.4%
Progression-free survival66.2%
Safety / AEs66.2%
Objective response / tumour response64.8%
Imaging / RANO-RAPNO assessment64.8%
Overall survival64.8%
Neurologic / cognitive / functional status33.8%
Biomarkers / PD / immunogenicity25.4%
PK / exposure16.9%
Endpoint category counted once per trial when present in primary, secondary, or explicitly exploratory-labelled endpoint text.
Interpretation

European glioblastoma/glioma trials are not built around a single endpoint hierarchy. Survival, radiographic response, safety, and patient-reported outcomes all appear as core evidence domains.

Primary endpoints emphasize QoL/PRO and OS; secondary endpoints broaden into response, imaging, and safety

QoL/PRO led both primary endpoints (28/71, 39.4%) and secondary endpoints (47/71, 66.2%). Overall survival was nearly as common as a primary endpoint (27/71, 38.0%), while objective response led the non-QoL secondary tier at 42/71 trials (59.2%).

Endpoint category by hierarchy, n=71
Endpoint
Primary
Secondary
Exploratory-labelled
QoL / PRO
39.4%
66.2%
5.6%
Overall survival
38.0%
53.5%
1.4%
Objective response
32.4%
59.2%
1.4%
Safety / AEs
32.4%
53.5%
1.4%
Imaging / RANO-RAPNO
28.2%
54.9%
0.0%
PFS
22.5%
54.9%
1.4%
Biomarkers / PD
2.8%
23.9%
5.6%
Percentages show trial-level presence within each endpoint hierarchy.
Interpretation

Primary endpoints split between direct patient benefit and hard survival evidence. Secondary endpoints absorb the fuller clinical package: PFS, response, RANO/RAPNO imaging, safety, QoL, and biomarker/PK support.

Phase II trials are more endpoint-dense; Phase III trials lean more strongly toward OS

In 46 Phase II-containing trials, QoL/PRO appeared in 38/46 (82.6%), while PFS and safety each appeared in 35/46 (76.1%). In 28 Phase III-containing trials, overall survival was the most common endpoint family at 17/28 (60.7%).

Phase II-containing n=46 vs Phase III-containing n=28
Phase II-containing
QoL/PRO82.6%
PFS76.1%
Safety76.1%
Objective response73.9%
Imaging/RANO71.7%
OS69.6%
Phase III-containing
OS60.7%
Imaging/RANO57.1%
PFS53.6%
QoL/PRO53.6%
Objective response50.0%
Safety46.4%
Mixed Phase II/III trials are included in both phase-containing strata.