Clinical trial · Interventional
A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)
A Phase II/III Randomized, Double-Blind Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat or Placebo in Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved.
Summary
Brief summary (as posted)
This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin
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 |
|---|---|---|---|
| Stage IIIB or IV Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: carboplatin | Drug | — | UNRESOLVED |
| Comparator: paclitaxel | Drug | — | UNRESOLVED |
| Comparator: placebo | Drug | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- vorinostat; IV paclitaxel; IV carboplatin
- interventionNames
- Drug: vorinostat
- Drug: Comparator: paclitaxel
- Drug: Comparator: carboplatin
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo; IV paclitaxel; IV carboplatin
- interventionNames
- Drug: Comparator: paclitaxel
- Drug: Comparator: carboplatin
- Drug: Comparator: placebo
Primary outcomes (1)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer * Patients with no systemic prior systemic treatment for lung cancer except patients at least 12 months from prior adjuvant therapy * Adequate bone marrow,kidney and liver function * Must be recovered and at least 4 weeks from major surgery or radiation * ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 * Men and women must agree to use birth control during the study * Women able to have children must have a negative pregnancy test 14 days before study enrollment Exclusion Criteria: * Patients with prior treatment with other investigational agents less than 4 weeks before study enrollment * Pregnant or nursing female patients * Patients who are HIV positive * Patients who have Hepatitis A, B, or C * Patients unable to take study medication by mouth * Patients with untreated brain cancer * Patient eligible for treatment with bevacizumab and for whom bevacizumab is available
References
Publications (1)
- DERIVEDBeaumont H, Souchet S, Labatte JM, Iannessi A, Tolcher AW. Changes of lung tumour volume on CT - prediction of the reliability of assessments. Cancer Imaging. 2015 Oct 31;15:17. doi: 10.1186/s40644-015-0052-2. PMID 26521238