E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of Stage IIIB-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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029522 |
E.1.2 | Term | Non-small cell lung cancer stage IV |
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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 |
To compare overall survival OS in patients treated with carboplatin, paclitaxel, and sorafenib to OS in patients treated with carboplatin, paclitaxel, and placebo |
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E.2.2 | Secondary objectives of the trial |
To monitor tumor response, duration of response, progression-free survival, and patient reported outcomes PRO To evaluate biomarkers that may relate the pharmacological mechanism of action of sorafenib to its antitumor activity |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
61623; Stage IIIB with pleural or pericardial effusion or Stage IV histological or cytological confirmation of NSCLC. 61623; No prior chemotherapy 61623; Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug. 61623; Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug. 61623; Age 18 years old. 61623; Eastern Cooperative Group ECOG Performance Status of 0 or 1 61623; Life expectancy of at least 12 weeks 61623; Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose 61623; Hemoglobin 9.0 g/dL 61623; Absolute neutrophil count 1500/mm3 61623; Platelet count 100 000/mm3 61623; Total bilirubin 1.5 times the upper limit of normal 61623; Alanine aminotransferase and aspartate aminotransferase 2.5 x upper limit of normal 5 x upper limit of normal for patients with liver involvement 61623; International Normalised Ratio 1.5 and a partial thromboplastin time within normal limits 61623; Creatinine 8804;1.5 times the upper limit of normal 61623; Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. 61623; Women of childbearing potential and men must agree to use adequate contraception barrier method of birth control prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. 61623; Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures. |
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E.4 | Principal exclusion criteria |
61623; Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC 61623; Cardiac disease Congestive heart failure class II New York Heart Association. Patients must not have unstable angina anginal symptoms at rest or new-onset angina began within the last 3 months or myocardial infarction within the past 6 months 61623; Known brain metastasis. Patients with neurological symptoms should undergo a computed tomography CT scan/magnetic resonance imaging MRI of the brain to exclude brain metastasis. 61623; Cardiac ventricular arrhythmias requiring antiarrhythmic therapy 61623; Uncontrolled hypertension defined as systolic blood pressure 150 mm Hg or diastolic pressure 90 mm Hg, despite optimal medical management. 61623; Known human immunodeficiency virus infection or chronic hepatitis B or C 61623; Active clinically serious infections 61502; Common Terminology Criteria for Adverse Events CTCAE Grade 2 61623; Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months 61623; Pulmonary hemorrhage/bleeding event CTCAE Grade 2 within 4 weeks of first dose of study drug 61623; Any other hemorrhage/bleeding event CTCAE Grade 3 within 4 weeks of first dose of study drug 61623; Serious, nonhealing wound, ulcer, or bone fracture 61623; Evidence or history of bleeding diathesis or coagulopathy 61623; Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug 61623; Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low-dose warfarin 1 mg orally every day is permitted if the International Normalised Ratio is 1.5. Low-dose aspirin is permitted. 61623; Use of St. John s wort or rifampin rifampicin 61623; Known or suspected allergy to sorafenib or any agent given in the course of this trial 61623; Previous cancer that is distinct in primary site or histology from NSCLC EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors Ta and Tis or any cancer curatively treated 3 years prior to study entry. 61623; Concurrent cancer that is distinct in primary site or histology from NSCLC 61623; Substance abuse, medical, psychological, or social conditions that may interfere with the patient s participation in the study or evaluation of the study results 61623; Any condition that impairs patient s ability to swallow whole pills 61623; Any malabsorption condition |
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
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 | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
| |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |