| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer |
| carcinoma polmonare non a piccole cellule avanzato o metastatico con mutazioni di EGFR |
|
| E.1.1.1 | Medical condition in easily understood language |
| A specific type of lung cancer called "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 | 20.0 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10029104 |
| E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| 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 |
Primary objectives are:
Part 1: To assess the noninferiority of amivantamab SC-CF administered via manual injection (Arm A1) versus amivantamab IV (Arm B1)
Part 2: To assess the bioequivalence of amivantamab SC-CF administered via manual injection (Arm A2) and amivantamab SC-CF OBDS (Arm B2) |
| Gli obiettivi primari sono valutare la non inferiorità farmacocinetica di amivantamab SC-CF tramite iniezione manuale rispetto ad amivantamab EV (Parte 1) e valutare la bioequivalenza di amivantamab SC-CF tramite iniezione manuale e amivantamab SC-CF OBDS (Parte 2). |
|
| E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess:
1. Efficacy of amivantamab SC-CF administered via manual injection (Arms A1 and A2) vs amivantamab IV (Arm B1) or amivantamab SC-CF OBDS (Arm B2)
2. Safety of amivantamab SC-CF administered via manual injection (Arms A1 and A2) vs amivantamab IV (Arm B1) or amivantamab SC-CF OBDS (Arm B2)
3. Amivantamab pharmacokinetics and immunogenicity to amivantamab or rHuPH20 in participants treated with amivantamab SC-CF administered via manual injection (Arms A1 and A2) vs amivantamab IV (Arm B1) or amivantamab SC-CF OBDS (Arm B2)
4. Cancer therapy satisfaction in participants treated with amivantamab SC-CF administered via manual injection (Arms A1 and A2) vs amivantamab IV (Arm B1) or amivantamab SC-CF OBDS(Arm B2)
5. Time and motion analysis in participants treated with amivantamab SC-CF administered via manual injection (Arms A1 and A2) vs amivantamab IV (Arm B1) or amivantamab SC-CF OBDS (Arm B2)
Refer the protocol for all secondary objectives
|
Gli obiettivi secondari principali sono valutare l’efficacia (tasso di risposta obiettiva [Objective Response Rate, ORR] e la sopravvivenza libera da progressione [Progression-Free Survival, PFS]) e la sicurezza delle diverse somministrazioni.
Gli obiettivi esplorativi sono descritti nel protocollo |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. Be =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent
2. Have histologically or cytologically confirmed, advanced or metastatic NSCLC, characterized by either EGFR Exon 19del or Exon 21 L858R mutation by an FDA-approved or other validated test of either ctDNA or tumor tissue in a CLIA certified laboratory or an accredited local laboratory. A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
3. Have progressed on or after osimertinib and platinum-based chemotherapy
•Osimertinib must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC.
•Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor.
•Any adjuvant or neoadjuvant treatment, whether with osimertinib or platinum-based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease progression within 6 months of the last dose.
4. Have at least 1 measurable lesion, according to RECIST v1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
6. Have adequate organ and bone marrow function as follows, without history of red blood cell transfusion or platelet transfusion within 7 days prior to the date of the laboratory test:
•Hemoglobin =9 g/dL
•Absolute neutrophil count =1.5×10^9/L, without use of granulocyte colony stimulating factor within 10 days prior to the date of the test
•Platelets =75×10^9/L,
•ALT and aspartate aminotransferase (AST) =3×upper limit of normal (ULN) if no demonstrable liver metastases or =5xULN in the presence of liver metastases.
•Total bilirubin
•=1.5×ULN if no demonstrated liver metastasis
• =3×ULN in the presence of liver metastasis
•=3×ULN for those participants with known Gilbert’s syndrome with
conjugated [direct] bilirubin <1.5xULN.
•Creatinine clearance >50 mL/min as measured or calculated by Modified Diet in Renal Disease (MDRD)
7. Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
a. No detectable viral load (ie, <50 copies/mL) at screening
b. CD4+ count >300 cells/mm^3 at screening
c. No acquired immunodeficiency syndrome -defining opportunistic infection within 6 months of screening
d. Receiving highly active antiretroviral therapy . A
8. Any toxicities from prior anticancer therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade =2 peripheral neuropathy, and Grade =2 hypothyroidism stable on hormone replacement)
9. A female participant of childbearing potential must have a negative serum pregnancy test at screening and must agree to further serum or urine pregnancy tests within 72 hours of the first dose, during the study, and for 7 months after the last dose of study treatment
10. A female participant must be either of the following:
a. Not of childbearing potential, or
b. Of childbearing potential and practicing at least 1 highly effective method of contraception, throughout the study and through 7 months after the last dose of study treatment.
Refer the protocol for all the inclusion criteria. |
1. Età =18 anni al momento del consenso informato.
2. Essere affetti da NSCLC avanzato o metastatico, istologicamente o citologicamente confermato, caratterizzato con mutazioni dell’esone 19del o dell’esone 21 L858R dell’EGFR, da un test approvato dall’FDA o da un altro test convalidato del ctDNA o del tessuto tumorale in un laboratorio certificato CLIA [Clinical Laboratory Improvement Amendments o in un laboratorio locale accreditato (centri al di fuori degli Stati Uniti). Una copia del referto del test iniziale che documenta la presenza della mutazione di EGFR deve essere inclusa nella documentazione del partecipante e una copia deidentificata deve essere trasmessa allo sponsor.
3. Presentare progressione durante o dopo osimertinib e chemioterapia a base di platino .
• Osimertinib deve essere stato somministrato come primo TKI di EGFR per la malattia metastatica o come secondo TKI dopo il trattamento precedente con TKI di EGFR di prima o seconda generazione in partecipanti con NSCLC metastatico positivo alla mutazione T790M di EGFR.
• I partecipanti che rifiutano o sono altrimenti non idonei alla chemioterapia possono essere arruolati dopo averne discusso con il responsabile del monitoraggio medico.
• Qualsiasi trattamento adiuvante o neoadiuvante, sia con osimertinib sia con chemioterapia a base di platino, conterà ai fini del precedente requisito di trattamento se il partecipante ha manifestato progressione della malattia entro 6 mesi dall’ultima dose.
4. Presentare almeno 1 lesione misurabile, secondo i criteri RECIST v1.1.
5. Performance status secondo il ECOG di grado 0 o 1.
6. Avere una funzionalità d’organo e funzione del midollo osseo adeguate, come specificato di seguito, in assenza di un’anamnesi di trasfusione di globuli rossi o trasfusione di piastrine nei 7 giorni precedenti la data del test di laboratorio:
• Emoglobina =9 g/dl
• Conta assoluta dei neutrofili =1,5×109/l, senza supporto con fattore stimolante le colonie granulocitarie nei 10 giorni precedenti la data dell’esame
• Piastrine =75×109/l
• ALT e AST =3×ULN in assenza di metastasi epatiche dimostrabili o =5xULN in presenza di metastasi epatiche.
• Bilirubina totale:
• =1,5×ULN se non sono state dimostrate metastasi epatiche
• =3×ULN in presenza di metastasi epatiche
• =3×ULN per i partecipanti con sindrome di Gilbert nota con bilirubina coniugata [diretta] <1,5xULN
• Clearance della creatinina >50 ml/min misurata o calcolata mediante MDRD
7. I partecipanti positivi al virus dell’immunodeficienza umana sono idonei se soddisfano tutti i seguenti requisiti:
a. Nessuna carica virale rilevabile allo screening
b. Conta delle CD4+ >300 cellule/mm3 allo screening
c. Assenza di infezione opportunistica che determina la sindrome da immunodeficienza acquisita entro 6 mesi dall’inizio dello screening
d. Trattamento con HAART.
8. Qualsiasi tossicità da una precedente terapia antitumorale deve essersi risolta al livello CTCAE Versione 5.0 Grado 1 o basale .
9. Una partecipante di sesso femminile potenzialmente fertile deve presentare un test di gravidanza negativo allo screening e deve acconsentire a ulteriori test di gravidanza su siero o urine entro 72 ore dalla prima dose, durante lo studio e per 7 mesi dopo l’ultima dose del trattamento dello studio.
10. La partecipante di sesso femminile deve soddisfare uno dei seguenti requisiti : a.Non essere in età fertile oppure b. Essere in età fertile e adottare almeno 1 metodo contraccettivo altamente efficace per tutta la durata dello studio e per 7 mesi dopo l’ultima dose del trattamento dello studio.
Fare riferimento al protocollo per tutti i criteri di inclusione. |
|
| E.4 | Principal exclusion criteria |
Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors, as allowed in Inclusion criterion 3.
2. Participant has a history of uncontrolled illness, including but not limited to the following:
•Uncontrolled diabetes
•Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection)
•Active bleeding diathesis
•Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of study treatment
•Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements
•Any ophthalmologic condition that is clinically unstable.
3. Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization.
4. Participant has symptomatic or progressive brain metastases. Participants with treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (=10 mg prednisone or equivalent) for at least 2 weeks prior to randomization are eligible.
5. Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.
6. Participant has uncontrolled tumor-related pain. Symptomatic lesions amenable to palliative radiotherapy (eg, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the randomization.
7. Participant has a medical history of ILD, including drug-induced ILD or radiation pneumonitis.
8. Have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s).
9. Participant has a history of hypersensitivity to any of the excipients of amivantamab, lazertinib, or to rHuPH20.
10. Participant has a history of clinically significant cardiovascular disease including, but not limited to, the following:
•Diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment, or any of the following within 6 months prior to the first dose of study treatment: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary.
•Prolonged QTcF interval >480 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (eg, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate).
•Uncontrolled (persistent) hypertension: systolic blood pressure >160 mmHg; diastolic blood pressure >100 mmHg
•Congestive heart failure (CHF) defined as New York Heart Association (NYHA) class III-IV or Hospitalization for CHF (any NYHA class) within 6 months of randomization
•Pericarditis/clinically significant pericardial effusion
•Myocarditis
11. Participant had major surgery (eg, requiring general anesthesia), excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 4 weeks before signing the ICF, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
Refer the protocol for all the exclusion criteria. |
1. Il partecipante ha ricevuto terapie citotossiche, sperimentali o mirate oltre un regime di chemioterapia a base di platino e inibitori di EGFR, come consentito dal criterio di inclusione 3.
2. Il partecipante ha un’anamnesi di malattia non controllata, tra cui, in modo non limitativo:
• Diabete non controllato
• Infezione in atto o attiva
• Diatesi emorragica attiva
• Nausea e vomito refrattari, malattie gastrointestinali croniche, incapacità di deglutire il prodotto formulato o pregressa resezione intestinale significativa che potrebbe impedire l’adeguato assorbimento del trattamento dello studio
• Malattia psichiatrica o qualsiasi altra circostanza che potrebbe limitare l’aderenza ai requisiti dello studio
• Qualsiasi condizione oftalmologica che sia clinicamente instabile
3. Il partecipante ha ricevuto radioterapia a scopi palliativi meno di 7 giorni prima della randomizzazione.
4. Il partecipante presenta metastasi cerebrali sintomatiche o progressive. Sono idonei i partecipanti con metastasi trattate clinicamente stabili e asintomatiche da almeno 2 settimane e che non ricevono un trattamento o ricevono un trattamento con corticosteroidi a basso dosaggio .
5. Il partecipante è affetto da malattia leptomeningea o presenta compressione del midollo spinale non trattata in modo definitivo con intervento chirurgico o radioterapia.
6. Il partecipante presenta dolore correlato al tumore non controllato. Le lesioni sintomatiche suscettibili di radioterapia palliativa devono essere state trattate da più di 7 giorni prima della randomizzazione.
7. Anamnesi di ILD [Interstitial Lung Disease (malattia polmonare interstiziale)], compresa l’ILD da farmaci, o polmonite da radiazioni.
8. Presentare un secondo tumore maligno pregresso o concomitante (diverso dalla malattia oggetto di studio) che potrebbe interferire con il decorso naturale o il trattamento con qualsiasi endpoint di sicurezza o efficacia del/i trattamento/i dello studio.
9. Anamnesi di ipersensibilità a uno qualsiasi degli eccipienti di amivantamab, lazertinib o a rHuPH20.
10. Anamnesi di malattia cardiovascolare clinicamente significativa, tra cui, a titolo esemplificativo ma non esaustivo, quanto segue:
• Diagnosi di trombosi venosa profonda o embolia polmonare entro 1 mese prima della prima dose del trattamento dello studio o una qualsiasi delle seguenti condizioni entro 6 mesi prima della prima dose del trattamento dello studio: infarto miocardico, angina instabile, ictus, attacco ischemico transitorio, innesto di bypass coronarico/arterioso periferico o qualsiasi sindrome coronarica acuta. La trombosi non clinicamente significativa, per esempio le forme associate a catetere non ostruttive, non costituisce motivo di esclusione.
• Intervallo QTcF prolungato >480 msec o aritmia cardiaca clinicamente significativa o malattia elettrofisiologica (ad es. posizionamento di defibrillatore cardioverter impiantabile o fibrillazione atriale con frequenza incontrollata).
• Ipertensione non controllata: pressione arteriosa sistolica >160 mmHg; pressione arteriosa diastolica >100 mmHg
• Insufficienza cardiaca congestizia (ICC), definita come classe III-IV secondo l’Associazione cardiologica di New York (New York Heart Association, NYHA) (vedere Appendice 9: Criteri della New York Heart Association) o ricovero ospedaliero per ICC (qualsiasi classe NYHA) entro 6 mesi dalla randomizzazione
• Pericardite/Versamento pericardico clinicamente significativo
• Miocardite
11. Anamnesi di intervento di chirurgia maggiore
Fare riferimento al protocollo per tutti i criteri di esclusione. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Part 1: Arm A1 vs Arm B1
1. Ctrough of amivantamab at steady state
2. AUCD1-D15
Part 2: Arm A2 vs Arm B2
3. Cmax of amivantamab
4. AUCD1-D8
|
Parte 1: Braccio A1 vs Braccio B1
1. Ctrough di amivantamab allo stato stazionario
2. AUCD1-D15
Parte 2: Braccio A2 vs Braccio B2
3. Cmax di amivantamab
4. AUCD1-D8 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Part 1: Arm A1 vs Arm B1
1. Cycle 4 Day 1
2. Cycle 2
Part 2: Arm A2 vs Arm B2
3. After Cycle 1 Day 1
4. Cycle 1
|
Parte 1: Braccio A1 vs Braccio B1
1. Ciclo 4 Giorno 1
2. Ciclo 2
Parte 2: Braccio A2 vs Braccio B2
3. Dopo il ciclo 1 giorno 1
4. Ciclo 1 |
|
| E.5.2 | Secondary end point(s) |
1. Overall response rate (ORR)
2. Progression-free survival (PFS)
3. Duration of response (DoR)
4. Time to response (TTR)
5. Incidence and severity of adverse events and clinical laboratory abnormalities
6. Incidence and severity of IRR
7. Ctrough of amivantamab (Part 1)
8. Model Predicted AUCD1-D15 (Part 1)
9. Ctrough of amivantamab (Part 2)
10. The presence of anti-amivantamab antibodies and anti-rHuPH20 antibodies
11. Modified TASQ
12. Change from baseline assessed over time
13. Participant chair time
14. Participant time in treatment room
15. Duration of treatment administration
16. Active HCP time for drug preparation, treatment administration, and post treatment monitoring.
17. Rate of successful injections with amivantamab SC-CF OBDS by HCP
18. Ease of Use and Satisfaction Questionnaire completed by HCP |
1. Tasso di risposta globale (ORR)
2. Sopravvivenza libera da progressione (PFS)
3. Durata della risposta (DoR)
4. Tempo di risposta (TTR)
5. Incidenza e gravità degli eventi avversi e delle anomalie cliniche di laboratorio
6. Incidenza e gravità dell'IRR
7. Ctrough di amivantamab (Parte 1)
8. Modello previsto AUCD1-D15 (Parte 1)
9. Ctrough di amivantamab (Parte 2)
10. La presenza di anticorpi anti-amivantamab e anticorpi anti-rHuPH20
11. TASQ modificato
12. Cambiamento dal basale valutato nel tempo
13. Tempo di presidenza del partecipante
14. Tempo del partecipante nella sala di trattamento
15. Durata della somministrazione del trattamento
16. Tempo attivo dell'operatore sanitario per la preparazione del farmaco, la somministrazione del trattamento e il monitoraggio successivo al trattamento.
17. Tasso di iniezioni riuscite con amivantamab SC-CF OBDS da parte dell'operatore sanitario
18. Questionario sulla facilità d'uso e sulla soddisfazione compilato dall'operatore sanitario |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-4. From randomization until the date of objective disease progression or death, whichever comes first
5-6. Throughout the study
7. Cycle 2 Day 1
8. Cycle 4
9. Cycle 4 Day 1
10. Day 1 of Cycle 1, 2, 3, 4, 5, 7, 9,11, EOT
11-12. Cycle 1 Day 1, Cycle 1 Day 2, Cycle 3 Day 1, EOT
13-16. Day 1 of Cycle 1 and 3
17. At each amivantamab SC-CF administration
18. Cycle 2 Day 1
|
1-4. Dalla randomizzazione fino alla data della progressione obiettiva della malattia o della morte, a seconda di quale evento si verifica per primo
5-6. Per tutto lo studio
7. Ciclo 2 Giorno 1
8. Ciclo 4
9. Ciclo 4 Giorno 1
10. Giorno 1 del Ciclo 1, 2, 3, 4, 5, 7, 9,11, EOT
11-12. Ciclo 1 Giorno 1, Ciclo 1 Giorno 2, Ciclo 3 Giorno 1, EOT
13-16. Giorno 1 del Ciclo 1 e 3
17. Ad ogni somministrazione di amivantamab SC-CF
18. Ciclo 2 Giorno 1 |
|
| 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 | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | Yes |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Tolerability, Immunogenicity and Biomarker evaluations |
| Valutazioni di tollerabilità, immunogenicità e biomarcatori |
|
| 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 | 4 |
| 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 | 70 |
| 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 |
| Argentina |
| Australia |
| Brazil |
| Canada |
| China |
| India |
| Israel |
| Japan |
| Korea, Republic of |
| Malaysia |
| Taiwan |
| Thailand |
| United States |
| France |
| Poland |
| Spain |
| Germany |
| Italy |
| Portugal |
| Turkey |
| 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
|
| 12 months after the last participant has been randomized |
| 12 mesi dopo la randomizzazione dell'ultimo partecipante |
|
| 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 | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| 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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