E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced, unresectable, or metastatic (Stage IIIB/IV) NSCLC. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029521 |
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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 first-line treatment with gemcitabine plus cisplatin (Gem/Cis) plus enzastaurin versus Gem/Cis plus placebo, followed by maintenance enzastastaurin or placebo, in terms of progression-free survival (PFS) in patients with advanced, unresectable, or metastatic (Stage IIIB/IV) NSCLC. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are as follows: to compare the response rates (RR) and the disease control rates (DCR) between treatment arms according to Response Evaluation Criteria in Solid Tumors (RECIST; Protocol Attachment S021.8) between arms to evaluate the following time-to-event efficacy variables for each treatment arm: o overall survival (OS) o duration of disease control (DDC) o duration of response (CR, PR) o time to worsening of symptoms (TWS) using the Lung Cancer Symptom Scale (LCSS; Protocol Attachment S021.6) to examine the safety and toxicity profile of study treatments to assess biomarkers relevant to enzastaurin and the disease state, as well as their correlation to clinical outcome |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
[1] Have histologic or cytologic diagnosis of advanced NSCLC (Stage IIIB disease with pleural effusion and/or positive supraclavicular nodes, or Stage IV disease) not amenable to curative treatment [2] Have measurable disease [3] Prior radiation therapy is allowed to <25% of the bone marrow [4] Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale [5] Have adequate organ function |
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E.4 | Principal exclusion criteria |
[1] Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment [2] Have documented central nervous system (CNS) metastases (except if adequately treated and stable for at least 4 weeks). Imaging is required in symptomatic patients to rule out brain or other CNS metastases, but is not required in asymptomatic patients [3] Have had myocardial infarction occurring <6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications [4] Have peripheral neuropathy of NCI CTCAE Grade 2 or above [5]Are unable or unwilling to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy |
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E.5 End points |
E.5.1 | Primary end point(s) |
PFS_Progression free survival |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |