| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC) |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10029521 |
| E.1.2 | Term | Non-small cell lung cancer stage IIIB |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
Main objective: (1) To determine the overall survival of patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC treated with paclitaxel plus carboplatin and vorinostat compared to patients treated with paclitaxel plus carboplatin and placebo. 2) To assess the safety, tolerability, and adverse experience profile of vorinostat administered in combination with paclitaxel plus carboplatin.
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| E.2.2 | Secondary objectives of the trial |
Secondary objectives: (1) To determine the progression-free survival of patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC treated with paclitaxel plus carboplatin and vorinostat compared to patients treated with paclitaxel plus carboplatin and placebo. (2) To determine the objective response rate of patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC treated with paclitaxel plus carboplatin and vorinostat compared to patients treated with paclitaxel plus carboplatin and placebo using conventional RECIST criteria
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Patient has a histologically- or cytologically-confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC
2. Patient has received no prior systemic chemotherapy, with the exception of adjuvant chemotherapy for NSCLC. If the patient has received prior adjuvant chemotherapy for NSCLC, it must have been completed 12 months or more prior to study enrollment
3. Patient is ≥18 years of age; has measurable disease as defined by at least 3 weeks from any prior major surgery or radiation therapy and has adequately recovered from the toxicity and/or complications of these interventions
4. Patient has Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1; adequate organ function.
5. Female patient of childbearing potential has a negative pregnancy test (serum) within 72 days of study enrollment.
6. Patient agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method)or (2) abstain from heterosexual activity throughout the study starting with Visit 1
7. Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study.
8. Patient or patient’s legal representative has voluntarily agreed to participate by giving written informed consent.
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| E.4 | Principal exclusion criteria |
1. Patient has been treated with any investigational agent for any indication within 4 weeks of study enrollment.
2. Patient has an active infection or has received intravenous antibacterial, antiviral, or antifungal medications within 2 weeks prior to enrollment.
3. Patient has a prior history of treatment with HDAC inhibitors. Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment.
4. Patient is on any systemic steroids for any indication, with doses that have not been stabilized to the equivalent of ≤10 mg/day prednisone during the 4 weeks prior to study enrollment.
5. Patients with untreated brain metastases or carcinomatous meningitis are excluded. However, patients who have stable CNS metastases off corticosteroids, and who are at least 4 weeks from the time of appropriate directed local therapy for CNS disease are eligible for protocol enrollment.
6. Patient is unable to take and/or tolerate oral medications on a continuous basis.
7. Patient has human immunodeficiency virus (HIV) infection or HIV-related malignancy.
8. Patient has active hepatitis A, B or C infection.
9. Patient is pregnant or breast-feeding.
10. Patient has a known allergy or hypersensitivity to any component of vorinostat or carboplatin.
11. Patient has a history of gastrointestinal surgery or other procedure that may in the opinion of the investigator, interfere with the absorption or intake of study drugs.
12. Patient has uncontrolled concurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric or social conditions that may interfere with patient compliance.
13. Patient has preexisting Grade 2 or higher neuropathy.
14. Patient has a history of prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed to be at low risk for recurrence by his/her treating physician.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Progression-free-survival (PFS) |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
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