E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open label study of erlotinib (Tarceva®) as single agent first line treatment of patients with locally advanced or metastatic lung adenocarcinoma with activating Epidermal Growth Factor Receptor (EGFR) mutations |
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E.1.1.1 | Medical condition in easily understood language |
Advanced Non-small Cell Lung Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029522 |
E.1.2 | Term | Non-small cell lung cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029521 |
E.1.2 | Term | Non-small cell lung cancer stage IIIB |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 evaluate the Progression Free Survival of Tarceva in patients with locally advanced or metastatic lung adenocarcinoma with activating EGFR mutations (identified by the Cobas® 4800 EGFR Mutation Test) in the routine clinical practice |
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E.2.2 | Secondary objectives of the trial |
To evaluate the Objective Response Rate and 1-Year Survival Rate
To evaluate the safety profile of Tarceva in this patient population.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologically or cytologically documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma.
NSCLC with an activating EGFR mutation (exon 19 microdeletions or exon 21 L858R point mutation) by using Cobas® 4800 EGFR mutation testing kit at a designated central laboratory.
Eastern Cooperative Oncology Group Performance Status of 0-2. |
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E.4 | Principal exclusion criteria |
Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed, if completed more than 6 months prior to study treatment. Prior radiochemotherapy is allowed, if completed more than 6 months before start of study treatment. Palliative radiotherapy must be completed at least 4 weeks before start of study treatment.
Prior therapy with systemic anti-tumor therapy with HER1/EGFR inhibitors.
Radical radiotherapy with curative intent within 28 days prior to enrolment.
Patients are excluded if they have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; patients previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months will also cause patients to be excluded.
Any inflammatory changes of the surface of the eye
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Tumor response (RECIST version 1.1.)
1-Year Survival Rate
Safety: Incidence, type and severity of adverse events
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Tumor response (RECIST version 1.1.)
1-Year Survival Rate
Safety: Incidence, type and severity of adverse events
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
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 | No |
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 |
Hungary |
Latvia |
Slovakia |
Turkey |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 6 |
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 | 6 |