E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
stage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy |
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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 | 10066490 |
E.1.2 | Term | Progression of 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 |
evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel.
primary endpoint: progression free survival |
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E.2.2 | Secondary objectives of the trial |
overall survival (key secondary endpoint) tumour response according to the modified RECIST criteria (objective tumour response, disease control, duration of disease control) incidence and intensity of adverse events according to the common terminology criteria for adverse events (CTCAE version 3.0) clinical improvement changes in safety laboratory parameters quality of life measured by standardized questionnaires (EQ-5D, EORTC QLQ-C-30, EORTC QLQ-LC-13) pharmacokinetics of BIBF 1120 (and of clinical relevant metabolites, if feasible) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• male or female patient aged 18 years or older • histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV (according to American Joint Committee on Cancers) or recurrent NSCLC (all histologies) • relapse or failure of one first line prior chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy) • at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT • life expectancy of at least three months • ECOG score of 0 or 1 • patient has given written informed consent which must be consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation |
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E.4 | Principal exclusion criteria |
more than one prior chemotherapy regimen for advanced and/or metastatic disease or recurrent NSCLC more than one chemotherapy treatment regimen prior to first line chemotherapy of advanced and/or metastatic or recurrent NSCLC previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy treatment with other investigational or anti-cancer drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial radiotherapy (except extremities and brain) within the past three months prior to baseline imaging active brain metastases radiographic evidence of cavitary or necrotic tumours centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels history of clinically significant haemoptysis within the past 3 months, therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy, history of major thrombotic or clinically relevant major bleeding event in the past 6 months, known inherited predisposition to bleeding or thrombosis significant cardiovascular disease inadequate safety laboratory parameters significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma preexisting ascites and/or clinically significant pleural effusion major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing serious illness, active infections requiring systemic antimicrobial therapy or concomitant non-oncological disease patients unwilling to use a medically acceptable contraception pregnancy or breast feeding psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol patients unable to comply with the protocol active alcohol or drug abuse other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix any contraindications for therapy with docetaxel history of hypersensitivity to docetaxel, polysorbate 80 (Tween 80), BIBF 1120, contrast media |
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E.5 End points |
E.5.1 | Primary end point(s) |
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 133 |
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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The clinical trial will be considered completed as soon as the last patient has died or was lost to follow-up. In case patients would still be on treatment when the report of the trial is being performed, these patients will either be included in a follow-up trial or alternatively kept on treatment in this trial. Those patients will then be reported in an addendum to the report. |
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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 | 4 |
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 | 4 |