Clinical trial · Interventional
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.
NCT00148395CI-TRIAL-00001418completedPhase 3ClinicalTrials.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)
This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer. It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Mitomycin | Drug | Mitomycin | ALIAS |
| Navelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (2)
- measure
- Event-free survival
- measure
- Quality of live
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results. 2. Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field 3. Age between 18 and 75 years 4. Karnofsky index 70 - 100% 5. Measurable or evaluable tumor parameter 6. No prior chemotherapy for NSCLC 7. Sufficient hematological parameter before start of therapy (leucocytes \> 3.500/µl and platelets \> 100.000/µl). 8. Sufficient liver function (bilirubin \< 1,6mg/dl) 9. Sufficient renal function (creatinine \< 1,5mg/dl and clearance \> 60ml/min) 10. Minimal estimated life expectancy \> 3 months 11. Written informed consent for study attendance 12. Patient accessibility for therapy and follow up 13. No attendance to an other study Exclusion Criteria: 1. Small-cell lung cancer oder tumors with small-cell fractions 2. Local advanced irradiable stage III 3. Previous chemotherapy because of other diseases, not longer than 3 years ago 4. Simultaneous radiation of all present tumor manifestations 5. Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma 6. Respiratory insufficiency 7. Heart insufficiency NYHA III and IV 8. Peripheral arteriosclerosis stage III and IV 9. Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol 10. Pregnancy, breastfeeding or not ensured contraception 11. HIV-infection 12. Active hepatitis B and C 13. Manifest infectious diseases before start of therapy 14. Minimal estimated life expectancy \< 3 months 15. No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.