Clinical trial · Interventional
Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen
Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen
NCT01850147CI-TRIAL-00010244unknownPhase 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)
The purpose of this study is to determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib, chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib
- interventionNames
- Drug: Sunitinib, chemotherapy
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- up to 2 years
- description
- The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- up to 2 years
- description
- To evaluate the median over-all survival of this regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of stage IIIB/IV NSCLC * ECOG PS: 0,1 * Unidimensional or bi-dimensional measurable disease * Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor * Evidence of disease progression * Life expectancy \>12 weeks * Neutrophils \> 1.5 109/l, Platelets \> 100 109/l, Hemoglobin \> 9g/dl, Total bilirubin \< 1.5 UNL, AST (SGOT) and ALT (SGPT) \< 2.5 UNL, Alkaline phosphatases \< 5 UNL, Creatinine \< 1 UNL Exclusion Criteria: * Pre-existing hemoptysis of a severity \> grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry * Uncontrolled hypertension * CHF, angina or arrhythmias * LVEF \< 1 UNL * Existing a second malignancy within 5 years * Infected with HIV
References
Publications (0)
Data not yet available
No reference posted for this study.