E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non small cell lung cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059515 |
E.1.2 | Term | Non-small cell lung cancer metastatic |
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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 |
At undersøge responsraten for kombinationsbehandling med carboplatin/vinorelbine og panitumumab til patienter med metastaserende NSCLC udvalgt på baggrund af KRAS/BRAF/PI3K mutationsstatus. |
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E.2.2 | Secondary objectives of the trial |
• At undersøge PFS for kombinationsbehandling med carboplatin/vinorelbine og panitumumab til patienter med metastaserende NSCLC, udvalgt på baggrund af KRAS/BRAF/PI3K mutationsstatus.
• At undersøge OS for kombinationsbehandling med carboplatin/vinorelbine og panitumumab til patienter med metastaserende NSCLC, udvalgt på baggrund af KRAS/BRAF/PI3K mutationsstatus.
• At vurdere den kliniske toksicitet og sikkerheden ved kombinationsbehandling med carboplatin/vinorelbine og panitumumab til patienter med metastaserende NSCLC, udvalgt på baggrund af KRAS/BRAF/PI3K mutationsstatus.
• At undersøge de prædiktive og prognostiske parametre ved translationel forskning.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologisk verificeret metastatisk (stadie IV) NSCLC • Målbar sygdom i henhold til RECIST • KRAS, BRAF og PI3K wild type i primær tumor eller metastatisk væv • Alder ≥18 • PS < 2 • Tilstrækkelig organfunktion • Samtykke til translationel forskning • Skriftligt informeret samtykke
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E.4 | Principal exclusion criteria |
• Klinisk signifikant kardiovaskulær sygdom (herunder myokardie¬infarkt, ustabil angina, symptomatisk kongestiv hjerteinsufficiens, alvorlig ukontrolleret hjertearytmi) < 1 år før inklusion/¬randomisering, aktive alvorlige infektioner eller anden alvorlig samtidig sygdom. • Kendt metastasering til centralnervesystemet (CNS) • Tidligere kemoterapi til metastatisk sygdom. • Indikation for strålebehandling eller tidligere strålebehandling inden for 30 dage før behandlingens start. • Andre maligne sygdomme inden for 5 år før inklusion i forsøget, med undtagelse af basalcelle- eller pladecelle¬karcinom i huden og carcinom-in-situ cervicis uteri. • Anden forsøgsbehandling inden for 30 dage før behandlingens igangsættelse. • Tidligere interstitiel lungesygdom, f.eks. pneumonitis eller pulmonal fibrose, eller tegn på interstitiel lungesygdom ved baseline CT-scanning af brystet. • Patienter, der er gravide, ammer eller har planer om at blive gravide inden for 6 måneder efter behandlingens afslutning. • Patienter, som ikke ønsker at bruge effektive prævention under behandlingen og 6 måneder efter behandlingens afslutning. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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 | 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) | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | 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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Sidste patient sidste besøg, juni 2013 |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |