Clinical trial · Interventional
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)
NCT00160069CI-TRIAL-00016251completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.
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 |
|---|---|---|---|
| Carcinoma, Non Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Sagopilone (BAY86-5302, ZK 219477)
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: Sagopilone (BAY86-5302, ZK 219477)
- type
- EXPERIMENTAL
- label
- Arm 3
- interventionNames
- Drug: Sagopilone (BAY86-5302, ZK 219477)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-small-cell lung cancer * Only one previous chemotherapy with a platinum-containing drug * Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: * No more than 1 previous chemotherapy for advanced disease * Previous participation in another trial within the last 4 weeks * Breast feeding * Active infections
References
Publications (1)
- RESULTHeigener DF, von Pawel J, Eschbach C, Brune A, Schmittel A, Schmelter T, Reck M, Fischer JR. Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy and safety of three regimens with two doses of sagopilone as second-line therapy in patients with stage IIIB or IV non-small-cell lung cancer. Lung Cancer. 2013 Jun;80(3):319-25. doi: 10.1016/j.lungcan.2013.02.007. Epub 2013 Mar 20. PMID 23522488