Clinical trial · Interventional
Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Phase I Study of the HDAC Inhibitor Vorinostat With Chemotherapy and Radiation Therapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT01059552CI-TRIAL-00041965NSCLCcompletedPhase 1ClinicalTrials.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 the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB 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 |
|---|---|---|---|
| Locally Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vorinostat
- description
- Dose escalation of vorinostat, cisplatin, pemetrexed and radiation
- interventionNames
- Drug: vorinostat
Primary outcomes (1)
- measure
- To assess that safety and maximally tolerated dose of vorinostat in combination with chemoradiation for unresectable locally advanced NSCLC.
- timeFrame
- toxicity assessments will occur weekly
Secondary outcomes (3)
- measure
- To investigate progression free survival.
- timeFrame
- CT/PET scans will be done after 12 weeks of therapy and at 12 week intervals until documented progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy proven non-squamous NSCLC with unresectable stage IIIA or dry IIIB disease. * FEV1 \>/= 1 liter * ECOG PS 0 or 1 * Able to swallow and absorb enterally * Measurable disease per RECIST 1.1 * Adequate organ and marrow function including calculated creatinine clearance \>/= 60 mL/min hepatic enzymes and alk phos \</= 2.5 X ULN. Exclusion Criteria: * Chemotherapy or radiotherapy \</= 4 weeks prior to registration (6 weeks for nitrosureas) * Active bleeding * Known brain mets * Prior thoracic radiotherapy that would lead to overlap with current radiation field. * More than 10% weight loss in 6 months. * Pancoast tumors, supraclavicular or contralateral hilar lymph node involvement * Known HIV positive * Prior treatment with an HDAC inhibitor
References
Publications (0)
Data not yet available
No reference posted for this study.