Clinical trial · Interventional
Docetaxel and Carboplatin Versus Docetaxel as Second Line Treatment in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
Multicenter Randomized Phase III Study Comparing Docetaxel With Carboplatin Versus Docetaxel Single Agent as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (NSCLC).
NCT00430651CI-TRIAL-00001944completedPhase 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 trial will compare the effectiveness of Docetaxel with or without Carboplatin as second line chemotherapy in patients with Non-Small Cell Lung Cancer, who have not been treated previously with Docetaxel.
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 |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Docetaxel + Carboplatin
- interventionNames
- Drug: Docetaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- Docetaxel
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Comparison of the overall survival between the two treatment groups
- timeFrame
- 1 year
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC. * ECOG Performance Status 0-2. * No previous treatment with Docetaxel. * Measurable Disease. * Brain metastases that have been treated with radiotherapy should be stable and asymptomatic. * Adequate liver kidney and bone marrow function. * Patients must be able to understand the nature of this study and give written informed consent. Exclusion Criteria: * Active cardiac disease: unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. * Women who are pregnant or lactating. * Unknown HIV, chronic hepatitis B or chronic hepatitis C infections. * Serious neurologic or psychiatric disease. * Second primary malignancy within the past 5 years, except nonmelanomas skin cancer or in situ carcinoma of the cervix. * Active uncontrolled infection.
References
Publications (0)
Data not yet available
No reference posted for this study.