| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Unresectable, locally advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) |
| Carcinoma del polmone non a piccole cellule (NSCLC) di stadio III non resecabile e localmente avanzato |
|
| E.1.1.1 | Medical condition in easily understood language |
| Stage III lung cancer condition |
| Carcinoma del polmone di stadio III |
|
| 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 | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10029519 |
| E.1.2 | Term | Non-small cell lung cancer stage III |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| 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 |
1. To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
2. To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab to concurrent chemoradiation therapy followed by durvalumab with respect to PFS per RECIST 1.1 as assessed by BICR.
3. To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to Overall Survival (OS).
4. To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab to concurrent chemoradiation therapy followed by durvalumab with respect to OS. |
1.Confrontare la Progression-Free Survival (PFS),valutata mediante Blinded Independent Central Review (BICR) in base ai criteri Response Evaluation Criteria in Solid Tumors RECIST 1.1,in seguito al trattam con pembrolizumab con chemioradioterapia concomitante seguito da pembrolizumab più olaparib e in seguito al trattam con chemioradioter concom seguita da durvalumab.
2.Confront la PFS valutata mediante BICR in base ai criteri RECIST 1.1 in seguito al trattam con pembrolizumab con chemioradioter concom seguito da pembrolizumab e in seguito al trattam con chemioradioter concom seguita da durvalumab.
3.Confront l’Overall Survival (OS) in seguito al trattam con pembrolizumab con chemioradioter concom seguito da pembrolizumab più olaparib e in seguito al trattam con chemioradioter concom seguita da durvalumab.
4.Confront l’OS in seguito al trattam con pembrolizumab con chemioradioter concom seguito da pembrolizumab e in seguito al trattam con chemioradioter concom seguita da durvalumab. |
|
| E.2.2 | Secondary objectives of the trial |
1. To evaluate the safety and tolerability of pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab alone or with olaparib compared to concurrent chemoradiation therapy followed by durvalumab.
2. To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab alone or with olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to Objective Response Rate (ORR) and Duration of Response (DOR) per RECIST 1.1 as assessed by BICR.
3. To evaluate the change from baseline (at Cycle 1) and the time to deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea and physical functioning following treatment with pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab alone or with olaparib compared to concurrent chemoradiation therapy followed by durvalumab. |
1Valut la sicur e la toller di pembrolizumab con chemiorad concom seg da pembro più olaparib risp a chemior conc seg da durvalumab
2Val la sicur e la toller di pembro con chemior conc seg da pembro risp a chemior conc seg da durval
3Confr pembro con chemior concom seg da pembro più olaparib risp a chemior conc seg da durval per quan rig l’objectiv resp rate(ORR) e la dur of resp(DOR)valut medBICRin base ai crit RECIST1.1
4Confr pembro con chemior conc seg da pembro risp a chemior conc seg da durval per quan rig ORReDOR valut medBICRin base ai critRECIST1.1
5Val la var risp al bas(al Ciclo1)e il TimetoTrueDeterioration(TTD)di stat di sal glob/qual di vit,tosse,dol torac,disp e funz fis in seg al trattam con pembro con chemior conc seg da pembro più olaparib risp a chemior conc seg da durval
6Val la var risp al bas(al Ciclo1)e il TTDdi stat di sal glob/qual di vit,tosse,dol tor,disp e funz fis in seg al trattam con pembro con chemior conc seg da pembro risp a chemior conc seg da durval |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1Has pathological(histologicalORcytological)confirmed diagnosis ofNSCLC
2Has StageIIIA,IIIB,orIIIC NSCLCbyAmericanJointCommitteeOnCancerV.8
3Is unable to undergo surgery with curat intent for StageIII NSCLC as document by a multidiscipl tum board or by the treat physician in consult with a thorac surgeon
4Has no evid of metast disease,indicat StageIV NSCLC,in whole-body fluorodeoxyglucose(FDG)-PETorFDG-PET/CT andCTorMRIscans of diagn quality of chest,abdomen,pelvisAndBrain
5Has measurab disease AsDefinedByRECIST1.1,with at least1lesion being appropr for select as aTargetLesion,as determ by local site investig/radiol rev
6Has not receiv prior treatm(chemother,targeted ther or radiother)for their StageIII NSCLC
7Has provided tum tissue sample(tissue biopsy[core,incisional,orExcisional]).FFPE blocks are prefer to slides.Newly obt tumor samp is highly prefer over archiv tissue and should be obt prior to the thorac imaging at screen
8Has a perform status of0or1on theECOG PerformStatus assessed within7ds prior to the1st administr of stud interv
9Has a lifeExpectOfAtLeast6months
10Has adequatePFTdefined as aFEV1>50%of predicted normal vol and the carbon monox lung diffusing capacity(DLCO)>40%of predicted normal value.Partic for whomDLCOmeasur are not avail will be deemed to have adeq oxygen transfer ifPulseOximetry(O2 satur)is determin to be=90%onRoomAir
11Has adeq organ function;all screen lab tests should be perform within10ds prior to initiat of stu interv
12Particip are at least18years of age on the day of signing the inform cons
13Male partic are eligib to particip if they agree toTheFollowing dur the interv per and for atLeast180ds after theLastDose of stu interv:
-Refrain from donat sperm
PLUSeither:
-Be absti from heterosex interc as their prefer and usual lifestyle(abst on a long term and persistent basis)andAgreeToRemain abst
OR
-MustAgreeToUse contracept as detail below:
Agree to use aMale condom plus partner use of an addi contrac method when having penile-vaginal intercour with aWOCBPwho is notCurrently pregn
-Contracept use by men should be consist with local regul regard the methods of contracep for those particip in clin stud.If the contracept requirem in the local label for any of the stu interv is +stringent than the requirem above,the local label requirem are to be followed
14A female particip is eligible to particip if she is not pregn or breastfeeding,and atLeast1of theFollow condit applies:
-Is not aWOCBP
OR
-Is aWOCBPand using a contracep method that is highly effect(failure rate of<1%per year)with low user depend,or be abst from heterosex interc as their prefer andUsual lifestyle(abst on aLong term and persist basis),dur the interv per and for at least180days after theLastDose of stu interv and agrees not to donate eggs(ova, oocytes)to others or freeze/store for her own use for the purpose of reproduct dur this per.The investig should evaluate the potent for contracep method fail(ie,noncompliance,recently initiated)in relation to the1st dose of stu interv
-AWOCBPmust have a - highly sensitive pregn test([urineOrSerum]as requir by local regul)within24h for urine or within72h for serum before the1st dose of stu interv
-If a urine test cannot be confirmed as - (eg,an ambiguous result),a serum pregn test is required.In such cases,the particip must be exclud from particip if the serum pregn result is+
-The investig is respons for rev of medical hist,mestrua hist,and recent sexual activ to decrease the risk for incl of aWomanWith an early undetec pregn
-Contracept use byWomenShould be consist with local regul regard the methods of contracep for those partic in clin stud.If the contracep requirem in the local label for any of the stu interv is + stringent than the requirem above,the local label requirem are to be followed
15Has(or legal accept represent if appl)provided writt inf cons/ass for the stu.The part may also provide cons/ass forFBR.However,the partic may particip in theMainTrial without particip inFBR
. |
1Ha diagn di NSCLC conferm patologic(istologicam o citologicam)
2È aff daNSCLCdi stadioIIIA,IIIB oIIIC cm defin dall’AmericanJointCommittee onCancerV.8
3Nn è in grado d sottop a1interv chirurg cn inten curat perNSCLC d stadioIIIcm document da1comit oncol multidiscipl o dal med cur in collabor cn1chirur torac
4Nn pres evid d malat metast,indicaz diNSCLC di stadioIV,da PET cn fluorodesossigluc(FDG-PET)“whole-body”o daFDG-PET/TCeTCoRM d qual diagn d tor,addome,pelvi e cerv
5È aff da1a mal misurab sec la v.1.1dei critRECIST,cn alm1a lesione adeg a ess selez cm les target in base al giud dell’invest/radiol del centr
6Nn si è sottop in pass a ter(chemioter,ter mirata o radioter)x il tratt dell’NSCLCdi stadioIII
7Ha forn1camp d tess tum(biopsia tissut[agobiopsia,biopsia incisionOescission]).I blocchi fiss in formal e incl in paraf(FFPE)sn prefer ai vetrini.I camp di tes tum d nuova acquisiz,sn altam preferib ai tess in archiv e dev ess otten prima dell’imaging del tor allo screen
8Pres1perform status di0o1 sec la scalaECOG valut nei7gg prec1a sommin del tratt sperim
9Ha 1aspett d vita pari ad alm6mesi
10Pres1a funz adeg aiPFT def cm 1FEV1>50%del val norm prev e1capac d diffus polmon x il monoss d carb(DLCO)>40%del val norm prev.Per i partec x i quali nn siano disponib misuraz diDLCO,il trasf d ossig sarà riten adeg nel caso in cui la pulsossim(satur di O2)sia valut=90%in aria amb
11Ha 1a funz d’org adeg;tut gli esami d lab d screen dev essere cond nei 10gg che prec l’iniz del tratt sperim
12I partec hanno alm18anni il gg della firma del cons inform
13I partec d ses masch sn idonei alla partecip se accett le segu condiz dur il per di tratt e x alm180gg dp l’ultim dose del tratt d stud:
-Asten dal don sperma Einoltre:
-Asten dal rapp eterosess cm stile d vita pref e usuale(astin a lun term e persist)e accett d riman in astin O
-Accett d utilizz met contracc cm riport d seg:
Accett d utilizz un preserv + l’uso da parte del partner di1met contracc aggiunt dur1rapp pene-vagin cn 1WOCBP che nn è attualm incinta
-L’uso della contrac da parte degli uom deve ess coer cn le norm locali riguard i met d contracc x col che partecip a stu clin.Se i requis d contrac nell’etichetta loc per 1quals dei trattam d stu sono +rigorosi dei requis d cui sopra,devono essere rispett i requis d etichettat loc
14Una partecip d ses femmin è idonea a partecip se nn è incinta o sta allatt e se alm 1delle cond riport d seg risulta app:
-Nn è1WOCBP O
-È 1WOCBP e utiliz 1met contraccet altam effic(tasso d fallim<1%all’anno),cn bassa dipend dell’utente,o che si astiene dal rapp eteroses cm stile d vita prefer e usual(astin a lungo term e persist)dur il tratt d stud e x alm180gg dopo l’ultima dose del tratt d stud e che accet d nn don uova(ovuli,ovociti)ad altri o d congel/conserv x uso person ai fini della riproduz dur questo per.Lo speriment deve valut il potenz fallim del met contrac(es,nn conform,iniziato recentem)in relaz alla1a dose del tratt d stud
-È1WOCBP che deve avere1test d gravid altam sens negat(urineOsiero)cm rich dalle norm locali,entro 24h x urine o entro72h x il siero prima della1a dose del tratt d stud
-Se 1test delle urine nn può essere conferm come -(ad es,1risultato ambig),è nec1test d gravid sierolog.In tali casi,la partec deve ess escl dalla partecip se il risult del test d grav sierolog è +
-Lo speriment è respons della revi della storia med,mestr e dell’attiv sess recen x ridur il rischio d inclus di1a donna con1a grav prec nn rilev
-L’uso della contracc da parte delle donne deve ess coer cn le norm locali riguard i met d contracc x col che partec a studi clin.Se i requis di contraccez nell’etichetta locale x1qualsiasi dei trattam di stu sn +rigorosi dei requis d cui sopra,devono essere rispett i requis d etichettat loc
15Ha forn(in1a pers o attr il rappres legalm riconosc,ove appl)il cons/asse inform scritto x lo stud.Il partec può inoltre forn il cons/ass a partec allaFBR.Tuttav,il sogg può partec allo stu princ senz partec allaFBR
.
. |
|
| E.4 | Principal exclusion criteria |
1HasSCLCor a mixed tumor with pres of small cell elem
2Has MDS/AMLor has features suggestive ofMDS/AML
3Has had docum weight loss>10%(from baseline)in the preceding3months
4Is likely to have a radiation treatm plan that will encomp a vol of whole lung(tot lungV20-GTV)receiv>20Gy in tot(V20)of + than34%of lung vol
5Has receiv prior radiother to the thorax,incl radiother to the esoph,mediast,or for breast canc
6Has receiv prior ther with an anti-PD-1,anti-PD-L1,or anti-PDL2agent or with an agent direct to anoth stimul or coinhib T-cell recep(eg,CTLA-4,OX-40,CD137)
7Has receiv prior ther with olaparib or with any otherPARPinhib
8Had maj surgery<4 weeks prior to the 1°dose of study medicat(exc for placem of vasc acc)
9Is expect to require any other form of antineopl ther,while on study
10Has receiv a live or live-attenuated vaccine within 30days before the first dose of stu interv.Administration of killed vaccines is allowed
11Has receiv colony-stim factors(e.g., G-CSF, GM-CSF, or recombinant erythropoietin)within28days prior to the1°dose of stu interv
12Is current receiv either strong or moder induc ofCYP3A4that cannot be discontin for the dur of the stu.The required washout per prior to start olaparib is5weeks for pentobarbital and3weeks for other agents
13Is current receiv either strong or moder inhib of cytochrP450(CYP)3A4that cannot be discontin for the dur of the stu.The requir washout per prior to start olaparib is2weeks
14Pemetrexed-specific:Is unable to interrupt aspirin or otherNSAIDs,other than an aspirin dose=1.3g per day,for at least2days(5days for long-acting agents[eg, piroxicam])before,during,and for at least2days after admin of pemetrexed
15Pemetrexed-specific:Is unable/unwilling to take folic ac,vitB12,and dexamethasone
16Is curr particip in or has particip in a stu of an investig agent or has used an investig dev within4weeks prior to the1°dose of stu interv
17The presence of uncontrolled,potentially revers cardiac cond,as judged by the investig or particip has congenital longQTsyndr
18Has a diagn of immunodef or is receiv chronic syst steroid ther(in dos exceeding10mgdaily of prednisone equiv)or any other form of immunosup ther within7days prior the1°dose of stu medic
19Has a known addit malignancy that is progressing or has requir act treatm within the past5years
20Has sev hypersens(=Grade3)to stu interv and/or any of its excip
21Has an active autoim dis that has requir syst treatm in past2years(ie,with use of disease modif agents,corticosteroids or immunosup drugs).Replacem ther(eg,thyroxine,insulin,or physiol corticosteroid replacem ther for adrenal or pituitary insuf)is not consider a form of syst treatm and is allowed
22Has a hist of(noninfectious)pneumon/interstit lung disease that requir steroids or has curr pneumonitis/interstitial lung dis.Lymphangitic spread of the NSCLC isn’t exclus
23Has an act infect requir syst ther
24Has a known hist of HIVinfection.NoHIVtest is requir unless mandated by local health author
25Has a known hist of HepatitisB(defined asHBsAg reactive)or known act HepC virus(defined as HCV RNA[qualitat]is detected)infect
26Has act tuberc and is receiv treatm
27Has a hist or current evid of any cond,ther,or lab abnormal that might confound the res of the study,interf with the participant's particip for the full dur of the study,or is not in the best inter of the particip to particip,in the opin of the treat investig
28In the opin of the treat investig,is consid a poor med risk due to a serious,uncontrol med disorder or nonmalign system dis
29Has a known psychiatr or subst abuse disor that would interfere with the particip abil to cooperate with the requi of the stu
30Is unable to swallow orally administ medicat or has a gastrointest disor affect absorp
31Is pregnant or breastfeeding or expecting to conceive or father childr within the projected dur of the stu,start with the screening visit through180days after the last dose of stu interv
32Has had an allogen tissue/solid organ transpl |
1È aff daSCLCo da tum misto cn pres di picc cell
2Ha la sindrome mielodisplastica(SMD)/leucemia mieloide acuta(LMA)o caratteristiche che suggeriscono la presenza diSMD/LMA
3Ha mostr1calo pond docum>10%(risp al bas)nei3mesi prec
4È probabile che abbia1piano radioter che includ1vol di polm intero(V20-GTV polm tot)con 1dose>20 Gy in tot(V20)di più del34%del vol polm
5Ha ricev1preced radiot al tor,incl 1radioter all’esof o al mediast o per il trat del carcin mamm
6Ha ricev1ter pregr a base di1agente anti-PD-1,anti-PD-L1 o anti-PD-L2 o di1ag dir contro1altro recet delle cell T co-inib o stimolat(es.CTLA-4,OX-40,CD137)
7Ha ricev1ter pregr cn olaparib o di1altroPARP-inib
8Si è sottop a1interv chirurg import<4 set prima della1°dose di farm sperim(eccez fat per il posiz di1acces vasc)
9Sec le previs,richied quals altr forma di ter antineopl dur la partecip allo stu
10È stato vaccin con vacc vivo o vivo-attenuato nei30gg preced la1°dose del tratt sperim.La somministrazione di vaccini inattivati è consentita
11Ha ricev fattori stimol le colonie(es.G-CSF,GM-CSF oEritropoietina ricombinante)nei28gg preced la1°dose d tratt sperim
12Sta assum indut diCYP3A4forti o mod che nn poss essere inter per la dur dello stud.Il per di washout rich prima di iniz il trattam cn olaparib è di 5settim x pentobarbital e3settim x gli altri ag
13Sta assum inib del citP450(CYP)3A4forti o mod che nn poss es interr per la dur dello stud.Il per di washout richiesto pri di iniz il trattam cn olaparib è di2settim
14Spec.per Pemetrexed:Nn è in grado d sosp l’assunz di aspirina o altri FANS,salvo1dose d aspirina=1,3g al gg,per alm2gg(5gg per gli ag ad az prol[ad es. piroxicam])prima,durante e x alm2gg dp la somm di pemetrexed
15Spec.per Pemetrexed:Nn è in grado/disp ad assum ac folico,vit B12 e desametasone
16Sta attualm partecip o ha partecip a1stu su1farm sperim o ha utiliz1disposit sperim nelle4sett prec la1°dose del trattam in stu
17La presenza di1rischio di cond card nn control e potenz rev,cm valutato dallo sperimentatore o soffre di sindr cong del QTlungo
18Ha1diagn di immunodef o sta assum1trattam cron cn steroidi sistem(in dosi super a10mg/die di1equival del prednisone)o quals altra forma di ter immunosop nei7gg preced la1°dose d trattam sperim
19È aff da1ulteriore tum mal noto in progres e o che ha rich 1trattam att negli ult5an
20Pres1grave ipersensib(=grado3)al farm sperim e/o a1quals dei suoi eccip
21È aff da1mal autoim att che ha rich il trat sistem negli ult2anni(uso di ag modific la mal,corticoster o farm immunosoppr).La ter di sost(es.ter di sostituz con tiroxina,insul o corticoster fisiol in caso di insuff ipofis o surrenalica)nn è consider una form di trat sistem
22Ha un’anamn di polmon(nn infett)/mal polm interstiz che ha rich il trattam con ster o una polm/mal polm interstiz in corso.La diff linfangit dell’NSCLC non costit 1crit di escl
23È aff da un’infez attiva che rich1ter sistem
24Ha un’anam nota posit per infez daHIV.Non è nec alcun test per il vir dell’HIV,salvo nei casi in cui ciò sia rich dalle autor san loc
25Ha un’anam nota di epB(HBsAg reat)o epC nota in atto(determ[qualit]dell’RNA del vir dell’epC[HCV RNA])
26È aff da tuberc at con tratt in corso
27Ha un’anam o pres attualm evid di quals cond,ter o anom di lab che possa confond i risult dello stud,interf cn la partecip del sogg allo stud per la sua int dur o casi in cui nn è nel migl inter del sogg partecip,sec il giud dello sperim curante
28Sec il giud dello sperim cur,pres 1rischio med sfavorev a causa d 1cond med seria e nn control o d 1mal sistem nn mal
29Pres dist noti di nat psichiatr o corr all’ab di sost che potreb interf cn il risp dei requi dello stud
30Nn è in gr di degl farm somm per via or o è aff da 1patol gastrointest che infl sull’assorb
31È in stato di gravid o allattam o pian di avere figli nel corso della dur prev dello stud,a part dalla vis di screen e per i180gg succes all’assunz dell’ult dose di tratt sperim
32Si è sottop a 1trap allog di org solido/tess |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
2. Overall Survival (OS) |
1. Sopravvivenza libera da progressione (PFS) secondo i criteri di valutazione della risposta sui tumori solidi versione 1.1 (RECIST 1.1) come valutato da BICR
2. Sopravvivenza globale (OS) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to approximately 48 months
2. Up to approximately 72 months |
1. Fino a circa 48 mesi
2. Fino a circa 72 mesi |
|
| E.5.2 | Secondary end point(s) |
1. Incidence of Adverse Events (AE)
2. Discontinuation Rate of Study Intervention Due to an Adverse Event (AE)
3. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
4. Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
5. Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score
6. Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score
7. Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
8. Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
9. Change From Baseline in Physical Functioning Using the EORTC QLQC30 Items 1- 5 Score
10. Time to Deterioration (TTD) in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score
11. TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score
12. TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
13. TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
14. TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score |
1. Incidenza di eventi avversi (AE)
2. Tasso di interruzione del trattamento di studio a causa di un evento avverso (AE)
3. Tasso di risposta obiettiva (ORR) secondo i criteri di valutazione della risposta in tumori solidi Versione 1.1 (RECIST 1.1) come valutato da BICR
4. Durata della risposta (DOR) secondo secondo i criteri di valutazione della risposta in tumori solidi Versione 1.1 (RECIST 1.1) coma valutato da BICR
5. Variazione rispetto al basale del punteggio di Stato di Salute Globale/Qualità della Vita nel Questionario sulla Qualità della Vita Core 30 (QLQ-C30) dell’Organizzazione Europea per la Ricerca ed il Tattamento del Cancro (Articoli 29 e 30)
6. Variazione rispetto al basale per la tosse utilizzando il Questionario sulla Qualità della Vita per il Carcinoma Polmonare Modulo 13 dell’Organizzazione Europea per la Ricerca ed il Trattamento del Cancro (EORT QLQ-LC13) Articolo 1
7. Variazione rispetto al basale per il dolore al petto utilizzando EORTC QLQ-LC13 Articolo 10
8. Variazione rispetto al basale per la dispnea utilizzando EORTC QLQ-C30 Articolo 8
9. Variazione rispetto al basale nel funzionamento fisico utilizzando EORTC QLQ-C30 Articoli 1-5
10. Time to Deterioration (TTD) in HRQoL utilizzando EORTC QLQ-C30 Articoli 29 e 30
11. TTD per tosse utilizzando EORTC QLQ-LC13 Articolo 1
12. TTD per dolore al petto utilizzando EORTC QLQ-LC13 Articolo 10
13. TTD per dispnea utilizzando EORTC QLQ-C30 Articolo 8
14. TTD per funzionamento fisico utilizzando EORTC QLQ-C30 Articoli 1-5 |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. to 4. Up to approximately 72 months
5. to 9. Baseline (at randomization) and at the end of study (approximately 72 months post randomization)
10. to 14. Up to approximately 72 months post randomization |
Da 1. a 4. Fino a circa 72 mesi
Da 5. a 9. Basale (alla randomizzazione) e alla fine dello studio (circa 72 mesi dopo la randomizzazione)
Da 10. a 14. Fino a circa 72 mesi dopo la randomizzazione |
|
| 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 | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| 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) | 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 | Yes |
| E.8.1.7.1 | Other trial design description |
| Gruppo A e B: doppio cieco; Gruppo C: in aperto |
| Group A and B: double-blind; Group C: open-label |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| 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 | 9 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 71 |
| 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 |
| Canada |
| Chile |
| China |
| Japan |
| Korea, Republic of |
| Mexico |
| Peru |
| Russian Federation |
| Thailand |
| Turkey |
| Ukraine |
| United States |
| Estonia |
| France |
| Germany |
| Hungary |
| Italy |
| Latvia |
| Norway |
| Poland |
| Romania |
| Spain |
| United Kingdom |
| Czechia |
|
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 6 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 6 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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