Clinical trial · Interventional
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives. The sponsor has decided to prematurely stop inclusions on January 13, 2022.
Summary
Brief summary (as posted)
Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tinzaparin Sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- usual care,
- type
- EXPERIMENTAL
- label
- Experimental
- description
- tinzaparin sodium
- interventionNames
- Drug: Tinzaparin Sodium
Primary outcomes (1)
- measure
- venous thromboembolic events
- timeFrame
- 6 months
- description
- All venous thromboembolism (VTE) events during the six-month treatment period including: * objectively confirmed symptomatic pulmonary embolism (PE), * objectively confirmed symptomatic lower-limb deep vein thrombosis (DVT) (including iliac and caval thrombosis), * objectively confirmed symptomatic upper extremity DVT, * objectively confirmed incidentally diagnosed PE or proximal DVT * death due to PE.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Social security affiliation * Written informed consent * Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission * D-dimer \> 1,500 µg/L * First line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion * ECOG (Eastern Cooperative Oncology Group) score 0-2 * Life expectancy \>3 months Exclusion Criteria: * Hypersensitivity to heparin or to any excipients * Septic endocarditis * History of heparin-induced thrombocytopenia * Ongoing anticoagulant treatment at therapeutic dosage * VTE at inclusion * Creatinin clearance \<30 mL/min * Active bleeding * Platelet count \< 100 G/L at inclusion * Severe hepatic insufficiency * Cancer treated exclusively with supportive care * Aspirin at daily dosage \> 160 mg * Pregnancy * Patient under tutorship or curatorship
References
Publications (0)
Data not yet available