E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epidermal growth factor receptor-expressing advanced non-small cell lung cancer. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Classification code | 10061873 |
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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 show superiority in terms of overall survival time of patients receiving platinum-based chemotherapy plus cetuximab as first-line treatment compared with patients receiving the same chemotherapy alone. |
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E.2.2 | Secondary objectives of the trial |
To compare between the two treatment groups: Progression-free survival (PFS) time Response rate Disease control rate Safety Quality of life (QoL) Cetuximab pharmacokinetics in the cetuximab arm via a population pharmacokinetics approach. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patient has given written informed consents before any study-related activities are carried out. Male or female, ≥18 years of age. Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV. Immunohistochemical evidence of EGFR expression on tumor tissue. Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area. ECOG performance status of ≤2 at study entry. White blood count ≥3 x 109/L with neutrophils ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥ 5.6 mmol/L (9 g/dL). Total bilirubin ≤1.5 x upper limit of normal (ULN) range. Aspartate aminotransferase (ASAT) and alanine-aminotransferase (ALAT) ≤ 5 x ULN. Serum creatinine ≤1.25 ULN and/or creatinine clearance ≥ 60 ml/min. Effective contraception for both male and female patients if the risk of conception exists. Recovered from relevant toxicities prior to study entry. |
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E.4 | Principal exclusion criteria |
Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy. Previous chemotherapy for NSCLC. Major surgery within 4 weeks prior to study entry. Prior chest irradiation within 12 weeks prior to study entry (palliative radiation of bone lesions is allowed). Treatment with any investigational agent(s) within 4 weeks prior to study entry. Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy for the treatment of cancer not indicated in the study protocol. Documented or symptomatic brain metastasis. Pre-existing ascites grade ≥2 and/or pericardial effusion grade ≥ 2. Superior vena cava syndrome contra-indicating hydration. Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre invasive carcinoma of the cervix. Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV. Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment. Known allergic/hypersensitivity reaction to any of the components of study treatments. Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade ≥2 and/or ototoxicity grade ≥2, except if due to trauma or mechanical impairment due to tumor mass. History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder. Medical or psychological condition that would not permit the patient to complete the study or sign informed consent. Known drug abuse. Pregnancy (absence to be confirmed by b-HCG test) or lactation period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point in this study is the overall survival time defined as the time from the day of randomization to death. |
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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 | Yes |
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 | 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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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
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Provided in the protocol, section 8.6 (page 79) |
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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 | |
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 |
E.8.9.2 | In all countries concerned by the trial months | 8 |