E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
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 | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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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 |
Separate assessment of the activity of each cetuximab maintenance therapy (500 mg/m² every 2 weeks and 250 mg/m² every week) in terms of overall survival time from inclusion in the trial to death in subjects with advanced NSCLC who are free of progression after having received cetuximab in combination with a platinum doublet chemotherapy as first-line treatment. |
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E.2.2 | Secondary objectives of the trial |
comprise the evaluation of activity in the maintenance therapy period and in the overall study period in terms of overall survival time (maintenance therapy phase only), time to treatment failure, unconfirmed tumor response and disease control, the evaluation of activity in Caucasian subjects and the comparison of the two maintenance therapy regimens. The safety of cetuximab in combination with platinumbased chemo-therapy and as single agent maintenance therapy when administered at doses of 250 mg/m² weekly or 500 mg/m² every 2 weeks will be evaluated |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Main inclusion criteria (for details see section 5.3.1): • Subject has given written informed consents before any trial-related activities are carried out • Male or female, ≥18 years of age at the time of informed consent, inpatient or outpatient • Adequate renal, hepatic and bone marrow function • Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIB NSCLC with pleural effusion or stage IV • Presence of at least 1 uni-dimensionally measurable index lesion, whereby index lesions must not lie in a previously irradiated area • ECOG performance status of 0 or 1 at inclusion in the trial • Effective contraception for male and female subjects, if risk of conception exists
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E.4 | Principal exclusion criteria |
Main exclusion criteria (for details see section 5.3.2): • Previous exposure to EGFR-targeting therapy (not monoclonal antibodies in general or signal transduction inhibitors, which would be allowed) • Previous chemotherapy for NSCLC; neo-adjuvant or adjuvant (radio-)chemotherapy is allowed if it was finished 6 months prior to start of trial treatment and no more than 300 mg/m² cisplatin was administered • Major surgery within 30 days prior to inclusion in the trial • Prior chest irradiation within 90 days prior to inclusion in the trial (palliative radiation of bone lesions is allowed) • Participation in another clinical trial or treatment with any investigational agent(s) within 30 days prior to inclusion in the trial • Documented or symptomatic brain metastasis • Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix • Cardiovascular or neurological impairment or infection that prevent the use of trial treatment |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival time defined as time from inclusion into the trial 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 | No |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
optional: Translational research |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |