In brief
- A systematic review examined venous thromboembolism (VTE) reporting in phase I to IV trials of targeted therapies, chiefly tyrosine kinase inhibitors, in fusion-positive non-small cell lung cancer (NSCLC), covering 108 reporting sources from 61 study entries (58 unique trials).
- Pulmonary embolism and deep vein thrombosis were the predominant reported events.
- VTE information was split between routes: 14 study entries reported events only in full-text publications, 19 only in online trial registry updates and 15 in both.
- More than 40% of study entries had no protocol-level anticoagulant therapy provisions, and nearly 60% had no VTE-related eligibility restrictions.
- The authors call for standardised safety reporting and for registry and publication data to be read together.
Study at a glance
- Design: Systematic review of trial protocols, publications and online registry updates
- Population: Phase I to IV trials of targeted therapies in fusion-positive NSCLC
- Scope: 108 reporting sources, 61 study entries, 58 unique trials
- Measured: Event ascertainment, reporting practice, anticoagulant therapy provisions and VTE-related eligibility criteria
- Most frequent events: Pulmonary embolism and deep vein thrombosis
- Reporting route: Publication only in 14 entries, registry only in 19, both in 15
- Protocol provisions: No anticoagulant therapy provisions in more than 40% of entries; no VTE-related eligibility restrictions in nearly 60%
Thromboembolic events split between journal articles and trial registries
The review drew on 108 reporting sources linked to 61 study entries, which corresponded to 58 unique trials across phases I to IV. Pulmonary embolism and deep vein thrombosis were the most frequently reported events.
Of the study entries, 14 disclosed thromboembolic events only in full-text publications and 19 only in online trial updates, while 15 used both. A reader working from the journal literature alone would therefore miss the events that 19 entries reported only to a registry.
Protocols seldom named thromboembolism as a dedicated safety outcome
When trial protocols dealt with VTE at all, they did so mostly through eligibility criteria, provisions on anticoagulant therapy or guidance on differential diagnosis. More than 40% of study entries carried no protocol-level provision on anticoagulant therapy, and nearly 60% set no VTE-related eligibility restriction.
The authors also found marked heterogeneity in event definitions, reporting practices, safety ascertainment and observation periods. Event counts gathered under different definitions and over different observation windows are therefore hard to compare across trials.
A limitation of ascertainment more than of event numbers
“In fusion-positive NSCLC trials, heterogeneity in event ascertainment and reporting, rather than a true scarcity of thromboembolic events, represents a major limitation of the available evidence.”Citarella et al., Critical Reviews in Oncology/Hematology (2026)
They propose greater standardisation of safety reporting, together with the integration of trial registry and publication data, which they say may improve the completeness, comparability and interpretability of future studies.
A review of how trials documented VTE, with no new patient data
The review’s subject is the quality of the trial evidence on thrombosis with these agents, which is a separate question from the size of the risk on any one drug. The authors place the work against the increasing recognition of VTE as a clinically relevant complication in patients with fusion-positive NSCLC.
Sources
- Critical Reviews in Oncology/Hematology. Venous Thromboembolism Reporting in Fusion-Positive NSCLC Treated with Tyrosine Kinase Inhibitors: A Systematic Review of Safety Reporting and Protocol-Level Provisions in Phase I-IV Clinical Trials. (2026-10-01). doi.org
Featuring Lung Summit faculty
This study was co-authored by Lung Summit faculty Alessio Cortellini.
This article was produced independently by the Lung Summit editorial team, without industry funding or input.
