E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced non small cell lung cancer in patients over seventy years old |
napredovali rak pljuč, nedrobnocelični, pri bolnikih nad sedemdeset let starosti |
|
E.1.1.1 | Medical condition in easily understood language |
advanced non small cell lung cancer |
napredovali rak pljuč, nedrobnocelični |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 |
Primary objectives of the trial: quality of life; treatment side effects |
Primarni cilj je ugotavljanje kvalitete življenja in neželenih učinkov |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives: time to progression, response to treatment according to RECIST; overall survival; treatment costs |
Sekundarni cilji: čas do napredovanja bolezni, odgovor na zdravljenjeglede na RECIST, preživetje, stroški zdravljenja |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age over 70 years; cytologically or histologically confirmed NSCLC; ; stage IV; chemo-naive; WHO performance status 0 – 2; standard criteria for platin-based chemotherapy; no other specific therapy is planned |
starost nad 70 let; citološko ali histološko verificiran ne-drobnocelični karcinom pljuč; ; stadij IV; kemonaivni bolniki; stanje zmogljivosti po WHO 0 – 2; standardni pogoji za zdravljenje s kemoterapijo na osnovi cisplatina; do napredovanja bolezni ne predvidevamo drugega specifičnega onkološkega zdravljenja |
|
E.4 | Principal exclusion criteria |
EGFR and ALK mutations positive
Previous chemotherapy
WHO performance status 3 or more
planned for combined modality treatment |
EGFR ali ALK pozitiven tumor
predhodna kemoterapija
WHO zmogljivost 3 ali več
planirana sočasna radioterapija |
|
E.5 End points |
E.5.1 | Primary end point(s) |
quality of life; treatment side effects |
kvaliteta bolnikovega življenja; sopojavi zdravljenja |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
before treatment, after 3 months , after 6 months |
pred zdravljenjem, po 3 mesecih, po 6 mesecih |
|
E.5.2 | Secondary end point(s) |
time to progression, response to treatment according to RECIST; overall survival; treatment costs |
čas do napredovanja bolezni; odgovor na zdravljenje po RECIST kriterijih; celokupno preživetje; stroški zdravljenja. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
median time from registration to first progresion and survival
response with RECIST after 3 months
|
srednji čas od registracije v študijop do prvega progresa oz. smrti
RECIST po 3 mesecih |
|
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 | 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 | 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) | 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 | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
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 | No |
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
|
trial will be completed after 120 patients are entered |
zaključek študije po vključitvi 120 pacienta. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |