Table 2.
Characteristics of the included studies
| Characteristics | Category or number | Total (n = 31), n (%) |
|---|---|---|
| Umbrella trial acronym and number of included sub-trials/arms | Lung-MAP | 5 (16.0a) |
| BATTLE | 4 (12.9) | |
| BATTLE-2 | 4 (12.9) | |
| Cluster trial | 4 (12.9) | |
| SUKSES | 4 (12.9) | |
| VIKTORY | 4 (12.9) | |
| FOCUS4 | 2 (6.5) | |
| PICCOLO | 2 (6.5) | |
| UmbHER1 | 2 (6.5) | |
| Study classification | Sub-study | 19 (61.2a) |
| Umbrella trial arm | 10 (32.3) | |
| Sub-study arm | 2 (6.5) | |
| Sub-trial/arm type | Experimental | 27 (87.1) |
| Experimental—non-match | 2 (6.5) | |
| Control group | 1 (3.2) | |
| Placebo | 1 (3.2) | |
| Therapy type | Targeted therapy | 21 (67.8a) |
| Targeted therapy with chemotherapy | 8 (25.8) | |
| Chemotherapy | 1 (3.2) | |
| Placebo | 1 (3.2) | |
| Publication year | 2019 | 14 (45.1a) |
| 2018 | 7 (22.6) | |
| 2016 | 4 (12.9) | |
| 2013 | 4 (12.9) | |
| 2011 | 2 (6.5) | |
| Location | North America | 13 (42.0a) |
| Asia | 12 (38.7) | |
| Europe | 5 (16.1) | |
| Australia | 1 (3.2) | |
| Funding | Mixed | 21 (67.7) |
| Private | 6 (19.4) | |
| Public | 4 (12.9) | |
| Sub-trial/arm status | Completed | 20 (64.5) |
| Closed at interim analysis | 7 (22.5a) | |
| Terminated | 2 (6.5) | |
| Unknown | 2 (6.5) | |
| Study definition | Phase II | 25 (80.6) |
| Phase III | 4 (12.9) | |
| Phase II/III | 2 (6.5) | |
| Total number of investigational drugs | 1 drug | 22 (71.0) |
| ≥ 2 drugs | 9 (29.0) | |
| Further studies recommended | No | 15 (48.3a) |
| Not reported | 8 (25.8) | |
| Yes | 6 (19.4) | |
| Not applicable | 2 (6.5) | |
| Enrolled patients, n (%) | 1637 (100) | |
| Patients evaluable for toxicity, n (%)b | 1379 (84.2) | |
| Patients evaluable for response, n (%)c | 1328 (81.1) | |
| Male patients, n (%)d | 512 (31.3) | |
| Median age at enrollment, n (%) of sub-studies/arms | Not reported | 13 (41.9) |
| < 65 | 13 (41.9) | |
| ≥ 65 | 5 (16.2a) | |
| Tumor type, n (%) of sub-studies/arms | Solid tumors | 31 (100) |
| Hematological malignancies | 0 (0) | |
| Stage of disease | Stage IIIB or IV or advanced or metastatic or relapsed | 30 (96.8) |
| Early and locally advanced | 1 (3.2) | |
| Performance status scale used, n (%) of sub-studies/arms | ECOG/WHO/Zubrod 0–1 | 9 (29.0) |
| ECOG/WHO/Zubrod 0–2 | 22 (71.0) |
ECOG Eastern Cooperative Oncology Group, WHO World Health Organization
a The percentage was calculated by subtracting the remaining % values from 100%
b The number of patients evaluable for toxicity was not reported in 8 sub-trials/arms
c The number of patients evaluable for response was not reported in 1 sub-trial
d Sex was not reported in 13 sub-trials/arms