Clinical trial · Interventional
A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
NCT00113516CI-TRIAL-00003456completedPhase 2Results postedClinicalTrials.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)
The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Drug: sunitinib
Primary outcomes (1)
- measure
- Proportion of Subjects Surviving at One Year
- timeFrame
- From start of treatment until 1 year or death
- description
- Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.
Secondary outcomes (36)
- measure
- Progression-free Survival (PFS)
- timeFrame
- From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven NSCLC * Stage IIIB (locally advanced with malignant effusion) or Stage IV disease * No prior therapy for NSCLC * Evidence of unidimensionally measurable disease Exclusion Criteria: * Previous treatment with systemic chemotherapy for lung cancer * History of or known brain metastases * NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment * Evidence of hemoptysis within 4 weeks of starting study treatment * Serious acute or chronic illness or recent history of significant cardiac abnormality * Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR
References
Publications (0)
Data not yet available
No reference posted for this study.