Clinical trial · Interventional
Taxotere-Enoxaparin-(ENOXA)-Study
Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as Single Therapy or in Combination With Enoxaparin in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, a Phase III Study
- 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 external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.
Summary
Brief summary (as posted)
Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin | Drug | — | UNRESOLVED |
| No Enoxaparin | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm B: Enoxaparin
- interventionNames
- Drug: Enoxaparin
- type
- ACTIVE_COMPARATOR
- label
- Arm A: No Enoxaparin
- interventionNames
- Other: No Enoxaparin
Primary outcomes (1)
- measure
- Progressive free survival
- timeFrame
- monthly
Secondary outcomes (6)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Men and women aged 18 and older * Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy * Life expectancy at least 12 weeks * EOCG performance \< 1 * Appropriate renal and hepatic function * Appropriate Hematology * No bleeding events within 4 weeks prior to randomization * No indication for prophylactic or therapeutic anticoagulation therapy * Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization * Capability for s.c. injection of Enoxaparin every 24 hrs Exclusion Criteria: * History of cancer other than NSCLC * Known contraindication for Enoxaparin e.g. HIT, * Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication * Participation in any other clinical trials within 30 days prior to randomization * Any known medical condition that does not allow therapy according to study protocol * Seizure disorder
References
Publications (0)
Data not yet available