Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
600
Countries
6
Sites
21
Advanced ROS1-positive NSCLC and other advanced ROS1-positive solid tumors
Phase 1 • To determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors Phase 2 • To evaluate the ORR of NVL-520 at the RP2D in patients with advanced ROS1-positive NSCLC
Key facts
- Sponsor
- Nuvalent Inc.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Feb 2022 → ongoing
- Decision date (initial)
- 2024-04-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Nuvalent, Inc.
External identifiers
- EU CT number
- 2024-511793-71-00
- EudraCT number
- 2021-002477-26
- ClinicalTrials.gov
- NCT05118789
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response, Therapy, Pharmacokinetic, Pharmacodynamic, Safety
Phase 1
• To determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors
Phase 2
• To evaluate the ORR of NVL-520 at the RP2D in patients with advanced ROS1-positive NSCLC
Secondary objectives 1
- Phase 1 - • To evaluate the overall safety and tolerability of NVL-520 • To characterize the PK profile of NVL-520 • To evaluate preliminary antitumor activity of NVL-520 in patients with advanced ROS1 positive solid tumors. Phase 2 - • To assess additional measures of clinical efficacy in patients with ROS1-positive NSCLC • To assess clinical efficacy in patients with non-NSCLC ROS1-positive solid tumors • To evaluate the intracranial antitumor activity of NVL-520 at the RP2D in patients with advanced ROS1-positive NSCLC and other solid tumors • To characterize the safety and tolerability of NVL-520 at the RP2D • To confirm the PK profile of NVL-520 and at the RP2D • To assess treatment-related symptoms and general health status using validated instruments of patient-reported outcomes (PROs) in patients treated with NVL-520
Conditions and MedDRA coding
Advanced ROS1-positive NSCLC and other advanced ROS1-positive solid tumors
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age ≥18 years a. Phase 2 Cohort 2e only: Age ≥12 years. 2. Disease criteria a. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. b. Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic ROS1 rearrangement. c. Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2d) with ROS1 rearrangement. 3. Prior anticancer treatment 4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease, defined as ≥1 radiologically measurable target lesion according to RECIST 1.1. 5. Pre-treatment tumor tissue. Please refer to the protocol for further criteria.
Exclusion criteria 1
- Patients meeting any of the following criteria will be excluded from the study: 1. Patient’s cancer has a known oncogenic driver alteration other than ROS1. 2. Known allergy/hypersensitivity to excipients of NVL-520. 3. Major surgery within 4 weeks of first dose of study drug. 4. Ongoing or recent anticancer therapy. Please refer to the protocol for further criteria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Phase 1 • RP2D and, if applicable, the MTD as determined by incidence of DLTs during Cycle 1, overall safety profile, PK, PD, and preliminary efficacy Phase 2 • ORR per RECIST 1.1.
Secondary endpoints 1
- • Incidence and severity of treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters • Pharmacokinetic parameters of NVL-520 − Maximum plasma concentration (Cmax); Cmax – dose normalized, plasma concentration at the end of the dosing interval (Ctau); average plasma concentration (Cavg); time of maximum concentration (Tmax); Please refer to protocol for further end points due to word limitation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11189826 · Product
- Active substance
- Zidesamtinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- NUVALENT INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD9730175 · Product
- Active substance
- Zidesamtinib
- Substance synonyms
- (6R)-22-Ethyl-54-fluoro-42,6-dimethyl-22H,42H-7-oxa-1(3,5)-pyridina-2(3,4)-pyrazola-4(4,5)-[1,2,3]triazola-5(1,2)-benzenacycloheptaphan-16-amine, NUV-520, NVL-520, (R)-3-Ethyl-16-fluoro-10-methyl-19-methyl-20-oxa-3,4,9,10,11,23-hexaazapentacyclo[19.3.1.02,6.08,12.013,18]pentacosa-1(24),2(6),4,8,11,13,15,17,21(25),22-decaen-22-ylamine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- NUVALENT INC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nuvalent Inc.
- Sponsor organisation
- Nuvalent Inc.
- Address
- 1 Broadway Floor 14th
- City
- Cambridge
- Postcode
- 02142-1187
- Country
- United States
Scientific contact point
- Organisation
- Nuvalent Inc.
- Contact name
- Medical
Public contact point
- Organisation
- Nuvalent Inc.
- Contact name
- Medical
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Charles River Laboratories Inc. ORG-100011991
|
Shrewsbury, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Tempus Labs Inc. ORG-100044006
|
Chicago, United States | Other |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Code 8 |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Precision for Medicine (HU) Kft. ORG-100040390
|
Budapest XII, Hungary | On site monitoring, Code 12, Code 2, Code 5, Data management, Code 9 |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Other |
Locations
6 EU/EEA countries · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 1 |
| France | Ongoing, recruiting | 100 | 4 |
| Germany | Ongoing, recruiting | 25 | 1 |
| Italy | Ongoing, recruiting | 40 | 7 |
| Netherlands | Ongoing, recruiting | 42 | 2 |
| Spain | Ongoing, recruiting | 56 | 6 |
| Rest of world
Japan, Canada, Taiwan, Korea, Republic of, Australia, United Kingdom, United States, Singapore
|
— | 317 | — |
Investigational sites
Institut Gustave Roussy
Oncologie médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Claudius Regaud / Oncopole / CHU Toulouse
Oncologie, 1 Avenue Irène Joliot Curie, 31059, TOULOUSE
Centre Hospitalier Universitaire De Nantes
Oncologie médicale, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Leon Berard
Oncologie médicale, 28 Rue Laennec, 69008, Lyon
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Medicina Oncologica 1, Via Giacomo Venezian 1, 20133, Milan
Istituto Oncologico Veneto
Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Delle Marche
Clinica Oncologica, Via Conca 71, 60126, Ancona
Istituto Tumori Bari Giovanni Paolo II
SSD Oncologia Medica per la Patologia Toracica, Viale Orazio Flacco 65, 70124, Bari
Azienda Unita Sanitaria Locale Della Romagna
U.O. Oncologia, Viale Vincenzo Randi 5, 48121, Ravenna
Istituto Europeo Di Oncologia S.r.l.
Divisione di Oncologia Toracica, Via Giuseppe Ripamonti 435, 20141, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
UOSD Sperimentazioni cliniche Fase 1 e Medicina di precisione, Via Elio Chianesi N 53, 00144, Rome
Universitair Medisch Centrum Groningen
Dept. of Pulmonology and Tuberculosis, Hanzeplein 1, 9713 GZ, Groningen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Pulmonology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'Hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Micancer Center S.L.P.
Oncology, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-06-01 | 2023-07-19 | |||
| France | 2022-03-08 | 2022-04-11 | |||
| Germany | 2024-01-22 | 2024-02-14 | |||
| Italy | 2024-03-13 | 2024-04-15 | |||
| Netherlands | 2022-05-17 | 2022-07-11 | |||
| Spain | 2022-02-28 | 2022-09-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 150 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511793-71-00_Redacted | 7.0 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC QLQ-C30_Paper_Dutch | 3 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC QLQ-C30_Paper_English | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC QLQ-C30_Paper_French | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC QLQ-LC29_Paper_Dutch | 1 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC QLQ-LC29_Paper_English | 1 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC QLQ-LC29_Paper_French | 1 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC_QLQ-C30_Screenshots_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC_QLQ-C30_Screenshots_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC_QLQ-LC29_Screenshots_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_BE_EORTC_QLQ-LC29_Screenshots_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_BE_Patient Diary_Dutch_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_BE_Patient Diary_English_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_BE_Patient Diary_French_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_Drug Dosing Patient Diary_en_NL_Redacted | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Drug Dosing Patient Diary_nl_NL_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_Emergency Card_DE_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_Emergency Card_FR_Redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C29 Screenshots_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C29_Paper_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30 Screenshots_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Paper_de_DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Paper_en_DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Paper_en_FR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Paper_en_IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Paper_fr_FR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Paper_it_IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Paper_NL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Screenshots_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Screenshots_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-C30_Screenshots_it_IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Paper_de_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Paper_en_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Paper_en_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Paper_en_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Paper_fr_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Paper_it_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Scoring manual_en_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Screenshots_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Screenshots_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_EORTC_QLQ-LC29_Screenshots_it_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary_IT_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_Patients Diary_DE_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_Patients Diary_en_FR_Redacted | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Patients Diary_fr_FR_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_Tablet UI_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Tablet UI_fr_BE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Tablet UI_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Tablet UI_nl_BE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Tablet UI_nl_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_Tablet UI_Screenshots_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Web Patient User Guide_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Web Patient User Guide_fr_BE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Web Patient User Guide_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Web Patient User Guide_nl_BE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Web Patient User Guide_nl_NL | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Web Patient User Guide_Screenshots_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Web UI_FR | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Web UI_fr_BE | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Web UI_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Web UI_nl_BE | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Web UI_nl_NL | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Web UI_Screenshots_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank document | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Ph2 Site Flyer_Digital_DE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Phase II Open Cohort Site Flyer_Redacted | 01.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Phase II Participant flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Phase II Site flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Phase II Solid Tumor Patient Flyer_Redacted | 01.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Phase II TKI-naive Patient Flyer_Redacted | 01.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Site Sheet_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Open Cohort Site Flyer_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_Dutch_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_Dutch_Redacted | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_English_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_French_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Open Cohort Site Flyer_Dutch BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Open Cohort Site Flyer_Dutch_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Open Cohort Site Flyer_English BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Open Cohort Site Flyer_French BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Open Cohort Site Flyer_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Open Cohort Site Flyer_Spain_Redacted | 1.3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Solid Tumor Patient Flyer_Dutch_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Solid Tumor Patient Flyer_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Solid Tumor Patient Flyer_Spain_Redacted | 1.3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Solid Tumour Patient Flyer_Dutch BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Solid Tumour Patient Flyer_English BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 Solid Tumour Patient Flyer_French BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 TKI-naive Patient Flyer_Dutch BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 TKI-naive Patient Flyer_Dutch_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 TKI-naive Patient Flyer_English BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 TKI-naive Patient Flyer_French BE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 TKI-naive Patient Flyer_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2 TKI-naive Patient Flyer_Spain_Redacted | 1.3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ph2_ Patient Flyer_DE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Flyer_Dutch_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Flyer_Dutch_Redacted | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Flyer_English_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Flyer_French_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_Redacted | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Site Flyer_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Solid Tumor Patient Flyer_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TKI-naive Patient Flyer_Redacted | 01 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Ado_FRA_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main Phase1_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Phase 1_French_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Phase 1.0_Dutch_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Phase 2_FRA_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Phase 2.0_Dutch_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_Phase 2.0 French_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DE_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_DE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_French_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant-Partner ICF_Redacted | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FRA__Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Phase 1 French_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Minors Study Assent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents Guardian Data Privacy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents Guardian Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Withdrawal Addendum to ICF_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Withdrawal Addendum to ICF_French_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Withdrawal_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Assent_Spain_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF Pregnant Partner_Spain_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Main ICF_Phase 1_Spain_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Main ICF_Spain_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Withdrawal_Spain_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material GP Letter_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material GP Letter_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_BE_2024-511793-71 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE-DE_2024-511793-71 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-511793-71 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES-ES_2024-511793-71 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-BE_2024-511793-71 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-FR_2024-511793-71 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT-IT_2024-511793-71 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL-BE_2024-511793-71 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL-NL_2024-511793-71 | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-18 | Belgium | Acceptable 2024-04-23
|
2024-04-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-15 | Belgium | Acceptable with conditions 2025-01-28
|
2025-01-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-08 | Acceptable with conditions | 2025-09-09 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-29 | Belgium | Acceptable 2026-01-19
|
2026-01-19 |