| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| NSCLC with squamous or nonsquamous histology |
| NSCLC con istologia squamosa o non squamosa |
|
| E.1.1.1 | Medical condition in easily understood language |
| Non-small cell lung cancer |
| Carcinoma polmonare non a piccole cellule |
|
| 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 | 10061873 |
| E.1.2 | Term | Non-small cell lung cancer |
| 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 (MK-3475) + lenvatinib (MK-7902) to docetaxel with respect to overall survival (OS) [Cohort 1]
2) To compare pembrolizumab + lenvatinib to docetaxel with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR) [Cohort 1]
|
1) Confrontare pembrolizumab + lenvatinib rispetto a docetaxel in termini di sopravvivenza complessiva (OS) [coorte 1].
2) Confrontare pembrolizumab + lenvatinib rispetto a docetaxel in termini di sopravvivenza libera da progressione (PFS) secondo i criteri RECIST 1.1 mediante revisione centrale indipendente in cieco (BICR) [coorte 1]. |
|
| E.2.2 | Secondary objectives of the trial |
1. To compare pembrolizumab + lenvatinib to docetaxel with respect to objective response rate (ORR) per RECIST 1.1 by BICR [Cohort 1]
2. To assess ORR with lenvatinib monotherapy per RECIST 1.1 by BICR [Cohort 2]
3. To assess duration of response (DOR) with pembrolizumab + lenvatinib and docetaxel per RECIST 1.1 by BICR [Cohort 1]
4. To assess the safety and tolerability of treatment with pembrolizumab + lenvatinib versus docetaxel [Cohort 1] and with lenvatinib monotherapy [Cohort 2]
5. To compare pembrolizumab + lenvatinib to docetaxel with respect to the mean change from baseline in global health status/quality of life (QoL), cough, chest pain, dyspnea, and physical functioning [Cohort 1]
6. To compare pembrolizumab + lenvatinib to docetaxel with respect to time to true deterioration (TTD) in global health status/QoL, cough, chest pain, dyspnea, and physical functioning scales [Cohort 1]
|
1Confrontare pembrolizumab+lenvatinib risp a docetaxel in termini di tasso di risp complessiva (ORR)secondo criteri RECIST 1.1 attr BICR[coorte 1].
2 Valutare ORR con lenvatinib in monoterapia sec criteri RECIST 1.1 attr BICR [coorte 2].
3.Valutare la durata della risp(DOR)con pembrolizumab + lenvatinib e docetaxel secondo criteri RECIST 1.1 attr BICR[coorte 1].
4.Valutare sicurezza e tollerabilità del trattam con pembrolizumab + lenvatinib rispetto a docetaxel. Valutare la sicurezza e la tollerabilità del trattamento con lenvatinib in monoterapia[coorti1 e 2].
5Confrontare pembrolizumab+lenvatinib risp a docetaxel in termini di variaz media dal basale nello stato di salute globale/qualità della vita(QoL), tosse, dolore al torace, dispnea e funzionalità fisica[coorte 1].
6Confrontare pembrolizumab + lenvatinib risp a docetaxel in termini di tempo effettivo peggior (TTD) nello stato salute globale/QoL, tosse, dolore al torace, dispnea e scale di funzionalità fisica [coorte 1]. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1Hav histolog or cytolog confirm diagnosis metastatic squamous or nonsquamous NSCLC
2Hav PD treat antiPD1/PDL1mAb administer either as monoth or in combinat with other checkpoint inhibitors or other therapies.Anti PD1/PDL1 treat progression is defined by meeting ALL of follow criteria:
Treat with at least 2 doses of an antiPD1/PDL1 mAb
PD after antiPD1/PDL1 mAb defin byRECISTv1.1The initial evidence of PD confirm by second assess no less than4weeks from date of first documented PD,in absence rapid clinical progression
PD docum within12weeks from last dose antiPD1/PDL1 mAb
3Hav PD during/after platinum doublet chemother
4Hav confirm that EGFR-, ALK-, or ROS1-direther is not indic primary ther(docum absence of tumoractiv EGFR mutats[DEL19oL858R],absence ofALKandROS1gene rearrangements OR presence of Kras mutat)
5Hav submit prestudy imaging that confirm evidence of PD bas on investigator review at least2images per RECIST 1.1,follow init of an antiPD1/PDL1 inhibitor
6Hav measurable disease bas on RECIST 1.1as determ by local site assessment.
Hav at least1measurable lesion byCTorMRI per RECIST 1.1
7Hav provided tumor tissue for PDL1 biomarker analysis from an archival sample(defin: from initial diagnosis ofNSCLC and prior to receiving immunother [antiPD-1/PD-L1],from primary lesion or metastatic lesion)
8Hav provid prior to alloc tissue from newly obtain formalinfix sample from new biopsy(defi as: after compl of immunoth[anti-PD-1/PD-L1]and before rece an allocation number),of tumor lesion not previously irradiated
9Be>=18 years of age day of signing the ICF
10Hav ECOG perform status of0or1within3days before first dose study interv but before allocation
11Hav life expect least3months
12Male participants rece pembrolizumab±lenvatinib or lenvatinib are eligible participate they agree to the follow during the interv period and for at least 120 days after the last dose study interv:
Male participants random docetaxel are eligible partic if they agree follow during intervention period and for at least 180 days after the last dose of docetaxel:Refrain from donating sperm
PLUS either:Be abstinent from heterosexual intercourse as their prefer and usual lifestyle(abstinent on a longterm and persistent basis)and agree to remain abstinent.
OR Must agree to use contrac unless confirm to be azoospermic (vasect or secondary to medical cause)
Agree to use a male condom plus partner use of add contrace method when having penilevaginal intercourse with a WOCBP who is not currently pregnant
13A female parti is eligible to participate if she isnot pregnant or breastfe and at least 1 the following cond applies:
Is not WOCBP OR Is WOCBP and using contrac meth that is highly effective(with failure rateof<1%year), with low user dependency, or abstinent from heterosexual intercourse as her pref and usual lifestyle (abstinent on a long term and persistent basis)dur interv period and for at least120days after the last dose of study inter,and agrees not to donate eggs(ova, oocytes)others or freeze/store these for her own use for the purpose of reprod dur this period
WOCBPrandom to docetaxel is eligible participate if she is using contraceptive method that is highly effective with low user dependency or is abstinent from heterosexual intercourse as her preferred and usual lifestyle and agrees not donate or freeze/store eggs during the intervention period and for at least180days after last dose of docetaxel
WOCBPmust hav negative highly sensitive pregnancy test(urine or serum as requir by local regulations)within72hours before the first dose of study interv
14Prov (legally accep repres must provide if appli)written infor consent for the study
15Hav adequately contr blood pressure(BP)with or without antihypertensive medications,defin as BP <=150/90mmHg and nochange in antihypertensive medic within1week before alloc
16If particip receiv major surgery or rad ther of>30Gy,they hav recov from toxicity and complicat from the interv
17Hav adeq organ func |
1Pres una diagnosi confermata punto vista istologico o citologico carc polmo nn a picc cell (NSCLC)metast, squam o nn squam
2PresPD dur trattam con un mAb antiPD1/PDL1 somm monot o associaz altri inibitori checkpoint o altre terapie.progress durante il trattam antiPD1/PDL1 viene def dal soddisf criteri:
Trattam alm2dosi mAb antiPD1/PDL1.
PDdp mAb antiPD1/PDL1,come def criteri RECISTv1.1.evidenza inizialePDviene confe med sec valutaz nn meno4sett dalla data prima PDdocum, in ass rap progres clin.
PDdocum entro12sett ultima dosemAbantiPD1/PDL1.
3CompPDdurante/dp chemioter doppietta base platino.
4Avere ric conf che la ter mirata a EGFR,ALKoROS1 nn ind come ter primaria(docum di ass di mut EGFR [es.DEL19oL858R] che attivano il tumore e ass di riarrang del gene ALK e ROS1OPP pres mutaz Kras).
5Pres imm pre-stu con conferma di PD in base alla revisione dello sperimalmeno 2 imm secondo i criteriRECIST1.1, dp l’inizio di un inibitore antiPD1/PDL1.
6Pres mal misurabile base criteriRECIST1.1,come dalla valutaz centro locale.
7Pres tess tumor per analisi del biomPD-L1 campione archivio (diagnosi iniziale di NSCLC e prima della ricez immunoter [antiPD1/PDL1], lesione primaria o da una lesione metastatica).
8Pres tessuto, prima dell’assegnaz, proveniente nuovo camp fissato in formalina ottenuto da una nuova biopsia (dp complet immunoter[antiPD1/PDL1] e prima della ricez del numero di assegnaz) di una lesione tumorale nn precedentemente irradiata.
9Età>=18 anni data firma ICF
10Stato validità ECOG pari 0o1nei3gg prec prima dose trattam stu,prima assegnaz.
11Aspet vita pari almeno a3mesi
12partec sesso maschile sono idonei partecipare ricevono pembrolizumab±lenvatinib o lenvatinib se acconst a quanto segue durante periodo trattam e almeno120gg dp l’ultima dose di trattam stu:
partec sesso masch random docetaxel sono idonei partecipare acconsentono quanto segue durante periodo trattam e almeno180gg ultima dose docetaxel:
Astenersi donaz sperma
PIÙ
Pratic astinenza rapp eterosess come stile vita preferito e abituale(astinenti lungo term e modo persistente) e acconsentire ad osservare l’astinenza in maniera continuativa.
OPP
Acc usare met contrac a meno nn abbia azoospermia conf(vasectomia o secondaria causa medica) descritto
Acco uso preservativo masch unito uso da parte partner metodo contraccettivo supplementare durante rapporti sess penili-vaginali donna età fertile (WOCBP) che attualmente nn è incinta
13partec sesso femm è idonea partec qualora nn gravida,nn stia allattando al seno e soddisfi almeno 1 condi seguono
Nn è donna età fertile.
OPP
donna età fertile e usa met contrac altam effic(con tasso insucc<1%anno),con bassa dipend per l’utente, o pratica astin rapp eterosess come stile vita preferito e abituale(astinenza lungo term e persistente),periodo di trattam e almeno120gg dp l’ultima dose trattam stu e acconsente a nn donare ovuli (ovociti) a terzi o a congelarli/conservarli per uso pers scopo riprod durante questo periodo.sperim deve valutare il potenziale di fallimento met contraccettivo (vale a dire, nn aderenza, inizio recente) in relaz alla prima dose di trattam dello stu.
donna età fertile random a docetaxel è idonea partecip se uso met contrac altam eff,bassa dip utente, o pratic astinenza dai rapporti eterosess come stile di vita preferito e abituale e acconsente a nn donare o congelare/conservare ovuli dur period trattam almeno180gg dp ultima dose di docetaxel.
donna età fertile deve pres un risultato negativo a un test di gravidanza altamente sensibile([urine o siero] come richiesto dalle normative locali)entro72ore prec prima dose trattam stu.
14Fornire personalm(o mediante un rappr legalm accettabile)consenso informato scritto per lo stu.
15Press arteriosa(PA) adeguat ctrl con o senza farmaci antipertensivi,def come PA <=150/90mmHg,ass mod farmaci antipertensivi entro1sett prima dassegnaz.
16partecip subito invento chir imp o sottop radioter dose>30Gydeve essersi ripreso tossic e/o complic del trattam.
17Funz org adeg |
|
| E.4 | Principal exclusion criteria |
1Has receiv docetaxel as monother or combin with other therap
2Has receiv lenvatinib as monother or combin with an antiPD1/PDL1 inhibitor
3Has receiv radiotherapy within 2 weeks before the first dose of study interv or has receiv lung radiat therapy >30 Gy within 6 months before the first dose of study interv
4Has receiv a live vaccine within 30 days before the first dose of study interv
5Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of study interv
6Has radiographic evidence of major blood vessel invasion/infiltration
7Has clinically significant cardiovascular impairment within 12months of the first dose of study interv, such as history of congestive heart failure greater than New York Heart Assoc Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack(TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability
8Has a history of a gastrointstinal condition or procedure that,opinion of the investigator, may affect oral study interv absorption
9Is a WOCBP who has a positive urine pregnancy test within 72 hours before allocation
10Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study interv
11Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg of prednisone or equivalent daily) or any other form of immunosuppressive therapy within 7 days before the first dose of study interv
12Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy
13Has known active central nervous system metastases and/or carcinomatous meningitis
14Has severe hypersensitivity (Grade>=3) to pembrolizumab and/or any of its excipients
15Has sensitivity to any of the excipients contained in lenvatinib
16Has sensitivity to any of the excipients contained in docetaxel
17Has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
18Has history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
19Has an active infection requiring systemic therapy
20Has known history of human immunodeficiency virus (HIV) infection
21Has known history of hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive or known active hepatitisCvirus (HCV)(defin as HCV RNA [qualitative] is detected) infection
22Has known history of active tuberculosis
23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the participant's participation for the full duration of the study, or it is not in the best interest of the participant to participate, in the opinion of the treating investigator
24. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
25. Has a left ventricular ejection fraction (LVEF) below the institutional normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
26. Has QT interval corrected with Fridericia’s formula (QTcF) prolongation to >480 ms
27. Has urinary protein =1 g/24 hours after having >1+ proteinuria on urine dipstick testing
28. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 180 days after the last dose of docetaxel
29. Has had an allogeneic tissue/solid organ transplant |
1Ha ricev docetaxel in monoter o in combinaz con altre terapie.
2Ha ricev lenvatinib in monoter o in combinaz con un inibitore anti-PD-1/PD-L1.
3Ha ricev radioter nelle 2 sett preced la prima dose di tratt dello stu o ha ricev radioter polmonare >30 Gy nei 6 mesi preced la prima dose di tratt dello stu.
4Ha ricev un vaccino vivo nei 30 gg preced la prima dose di tratt dello stu.
5Pres emottisi clinica significativa (quantità di sangue rosso brillante pari ad almeno 0,5 cucchiaini) o sanguinamento tumor nelle 2 sett preced la prima dose di tratt dello stu.
6Evidenza radiol di invasione/infiltraz di vasi sanguigni di grosso calibro.
7Presnza di compromis cardiovasc clinicam significativa entro 12 mesi dalla prima dose di tratt dello stu, come per esempio anamnesi di insuff cardiaca congestizia di classe sup a II sec la classificaz della New York Heart Association (NYHA), angina instabile, infarto miocardico o ictus cerebrovascolare/attacco ischemico transitorio (TIA)/ictus, rivascolarizzaz cardiaca opp aritmia cardiaca associata a instabilità emodinamica.
8Pres anamnesi condiz o procedura gastrointestinale che, a giudiz sperim,potrebbe influire assorb orale del tratt dello stu.
9Partecip di sesso femm età fertile con test di gravidanza urine positivo72ore preced assegnaz
10Sta attualm partecipando sperime clinica e ricevendo terapia stu opp ha partecipato a uno stu su un agente sperimentale entro 4 sett dalla prima dose del tratt stu.
11Diagnosi di immunodef o tratt in corso con terapia steroidea sistemica cronica (sup a 10 mg al giorno di prednisone o equiv)o qualsiasi altra forma di terapia immunosoppr7gg preced la prima dose di tratt stu.
12Pres anamnesi nota di ulteriore malignità, tranne caso in cui il partecip abbia ricev una terapia potenzialm curativa senza evidenza di recidiva della malattia per3anni dall’inizio tale terapia.
13Pres metastasi attive note nel sist nervoso centrale e/o meningite carcinomatosa.
14Pres ipersensi grave(grado >=3)a pembrolizumab e/o a uno qualunque dei suoi eccipienti.
15Pres sensi quals eccip contenuti lenvatinib.
16Pres sensi quals eccip contenuti docetaxel.
17Malattia autoimmune in fase attiva che abbia richiesto un tratt per via sistemica negli ultimi 2 anni (ovvero, con impiego di agenti modificanti la malattia, corticosteroidi o farmaci immunosoppressori).
18Pres anamnesi di polmonite (non infettiva) che ha richiesto uso di steroidi per via sistemica o pres una polmonite/malat polmonare interstiziale corrente.
19Pres infez attiva con necessità di terapia sistemica.
20Pres anamnesi nota di infez da virus dell’immunodef umana (HIV).
21Pres anamnesi di infez da virus epatiteB(definita come reattiva antig di super epatiteB [HBsAg])o nota infez attiva da virus epatiteC(definita come rilevamentoHCV RNA[qualitativa]).
22Pres un’anamnesi nota di tubercolosi attiva. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Cohort 1: Overall Survival (OS)
2. Cohort 1: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
1. Coorte 1: Sopravvivenza complessiva (OS)
2. Coorte 2: Sopravvivenza libera da progressione (PFS) con valutazione per risposta Criteri in tumori solidi Versione 1.1 (RECIST 1.1) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to ~52 months
2. Up to ~37 months
|
1. fino a 52 mesi
2. fino a 37 mesi |
|
| E.5.2 | Secondary end point(s) |
1. Cohorts 1 and 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
2. Cohort 1: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
3. Cohorts 1 and 2: Number of Participants Experiencing an Adverse Event (AE)
4. Cohorts 1 and 2: Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
5. Cohort 1: Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score
6. Cohort 1: Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score
7. Cohort 1: Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
8. Cohort 1: Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
9. Cohort 1: Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
10. Cohort 1: Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
11. Cohort 1: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score
12. Cohort 1: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
13. Cohort 1: Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
14. Cohort 1: Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score |
1. Coorti 1 e 2: Tasso di risposta obiettiva (ORR) Criteri di valutazione per risposta in tumori solidi Versione 1.1 (RECIST 1.1)
2. Coorte 1: Durata della risposta (DOR) Criteri di valutazione per risposta in tumori solidi Versione 1.1 (RECIST 1.1)
3. Coorti 1 e 2: numero di partecipanti che sperimentano un evento avverso (AE)
4. Coorti 1 e 2: numero di partecipanti che interrompono il trattamento di studio a causa di un evento avverso (AE)
5. Coorte 1: cambiamento rispetto al basale nell'organizzazione europea per la ricerca e il trattamento (EORTC) Questionario sulla qualità della vita - Core 30 (QLQ-C30) Stato globale della salute / Qualità della vita (articoli 29 e 30) Punteggio in scala
6. Coorte 1: Cambiamento rispetto al basale in EORTC Questionario sulla qualità della vita Modulo cancro al polmone 13 (QLQ-LC13) Tosse (Articolo 31) Punteggio in scala
7. Coorte 1: variazione rispetto al basale in EORTC QLQ-LC13 Dolore al petto (item 40) Punteggio in scala
8. Coorte 1: variazione rispetto al basale in EORTC QLQ-C30 Dyspnea (elemento 8) Punteggio in scala
9. Coorte 1: variazione rispetto al basale nel funzionamento fisico EORTC QLQ-C30 (voci da 1 a 5) Punteggio in scala
10. Coorte 1: Time to True Deterioration (TTD) in EORTC QLQ-C30 Stato salute globale / Qualità della vita (articoli 29 e 30) Punteggio in scala
11. Coorte 1: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Punteggio in scala
12. Coorte 1: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Dolore al petto (item 40) Punteggio in scala
13. Coorte 1: Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Articolo 8) Punteggio in scala
14. Coorte 1: Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Articoli 1 a 5) Punteggio in scala |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to ~5 years
2. Up to ~5 years
3. Up to ~5 years
4. Up to ~5 years
5. Baseline and Week 12
6. Baseline and Week 12
7. Baseline and Week 12
8. Baseline and Week 12
9. Baseline and Week 12
10. Up to ~5 years
11. Up to ~5 years
12. Up to ~5 years
13. Up to ~5 years
14. Up to ~5 years |
1. Fino a ~ 5 anni
2. Fino a ~ 5 anni
3. Fino a ~ 5 anni
4. Fino a ~ 5 anni
5. Linea di base e settimana 12
6. Linea di base e settimana 12
7. Linea di base e settimana 12
8. Linea di base e settimana 12
9. Linea di base e settimana 12
10. Fino a ~ 5 anni
11. Fino a ~ 5 anni
12. Fino a ~ 5 anni
13. Fino a ~ 5 anni
14. Fino a ~ 5 anni |
|
| 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 | 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 | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| 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 | 35 |
| 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 |
| Australia |
| Canada |
| Colombia |
| Israel |
| Japan |
| Korea, Republic of |
| Russian Federation |
| United States |
| France |
| Italy |
| Spain |
| United Kingdom |
|
| 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 | 5 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 5 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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