Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
393
Countries
5
Sites
18
First-line treatment of participants with metastatic nonsmall cell lung cancer
1. To compare MK-3475A SC to pembrolizumab IV with respect to AUC 2. To compare MK-3475A SC to pembrolizumab IV with respect to steady-state Ctrough
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Apr 2023 → ongoing
- Decision date (initial)
- 2023-04-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-501506-36-00
- WHO UTN
- U1111-1280-9384
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic
1. To compare MK-3475A SC to pembrolizumab IV with respect to AUC
2. To compare MK-3475A SC to pembrolizumab IV with respect to steady-state Ctrough
Secondary objectives 9
- To evaluate pembrolizumab exposure for MK-3475A SC relative to pembrolizumab IV
- To evaluate the development of circulating anti-pembrolizumab antibodies for MK-3475A SC and pembrolizumab IV
- To evaluate pembrolizumab Ctrough for MK-3475A SC relative to pembrolizumab IV
- To evaluate MK-3475A SC and pembrolizumab IV with respect to ORR per RECIST 1.1 as assessed by BICR
- To evaluate MK-3475A SC and pembrolizumab IV with respect to PFS per RECIST 1.1 as assessed by BICR
- To evaluate MK-3475A SC and pembrolizumab IV with respect to OS
- To evaluate MK-3475A SC and pembrolizumab IV with respect to DOR per RECIST 1.1 as assessed by BICR
- To evaluate the safety and tolerability of MK-3475A SC and pembrolizumab IV
- To evaluate the change from baseline in global health status/QoL for MK-3475A SC and pembrolizumab IV
Conditions and MedDRA coding
First-line treatment of participants with metastatic nonsmall cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
- Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
- Has a life expectancy of at least 3 months
Exclusion criteria 14
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has received prior systemic anticancer therapy for metastatic NSCLC
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids
- Has received radiation therapy to the lung (>30 Gray) within 6 months of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has a history of human immunodeficiency virus (HIV) infection
- Has a history of Hepatitis B or C
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has a history of allogenic tissue/solid organ transplant
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
- Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Secondary endpoints 14
- Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose
- Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose
- Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State
- Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State
- Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab
- Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
- Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
- Overall Survival (OS)
- Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
- Number of Participants Who Experienced at Least One Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
- Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30
- Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5
- Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9357633 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0 % percent
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 12
Pazenir 5 mg/ml powder for dispersion for infusion
PRD7328588 · Product
- Active substance
- Paclitaxel Albumin-Bound
- Substance synonyms
- PACLITAXEL ALBUMINE-BOUND
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 100 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- EU/1/18/1317/001
- MA holder
- RATIOPHARM GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paclitaxel EVER Pharma 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD6187383 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 96558.00.00
- MA holder
- EVER VALINJECT GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD2433080 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 150 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 100 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP180112 · ATC
- Active substance
- Glatiramer Acetate
- Substance synonyms
- COPOLYMER-1
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AA13 — PEGFILGRASTIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 Other
- Max total dose
- 6 Other
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD669106 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 Other
- Max total dose
- 6 Other
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 84223.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD662245 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 71983.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 75 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP147553 · ATC
- Active substance
- Filgrastim
- Substance synonyms
- NT100H, FILGRASTIM (GENETICAL RECOMBINATION)
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 % (V/V) percent volume/volume
- Max total dose
- 0 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AA02 — FILGRASTIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jianda Yuan
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jianda Yuan
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Management Limited ORG-100040504
|
London, United Kingdom | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Other |
| Parexel International Corporation ORG-100007310
|
Auburndale, United States | Other |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Other |
| Q Squared Solutions LLC. ORL-000008178
|
Valencia, United States | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| PPD Development LP ORG-100011560
|
Richmond, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
5 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 2 | 3 |
| Hungary | Ongoing, recruitment ended | 33 | 5 |
| Poland | Ongoing, recruitment ended | 22 | 2 |
| Romania | Ongoing, recruitment ended | 30 | 4 |
| Spain | Ongoing, recruitment ended | 13 | 4 |
| Rest of world
South Africa, Japan, Turkey, Chile, Thailand, United States, Brazil, Guatemala, Taiwan, China, Argentina
|
— | 293 | — |
Investigational sites
Centre Hospitalier Regional Universitaire De Tours
Service de Pneumologie, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Intercommunal De Cornouaille
Oncologie médicale, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Assistance Publique Hopitaux De Paris
Service de Pneumologie - Unité d'oncologie thoracique (Bâtiment Cornil Brissaud), 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
Reformatus Pulmonologiai Centrum
Onkopulmonológiai Járóbeteg Centrum, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Semmelweis University
Pulmonológiai Klinika, Tomo Utca 25-29, 1083, Budapest VIII
Koranyi National Institute For Pulmonology
VI. Tüdőbelosztály és Bronchológia, Koranyi Frigyes Ut 1, 1121, Budapest XII
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Onkológiai Központ, Toszegi Ut 21, 5000, Szolnok
Warminsko Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii z PododdziałemChemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Oncomed S.R.L.
Oncologie Medicala, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Radiotherapy Center Cluj S.R.L.
Oncologie, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Centrul De Oncologie Sf Nectarie S.R.L.
Omcologie, Strada Caracal Nr. 109, 200746, Craiova
Complexo Hospitalario Universitario De Santiago
Medical Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Juan Ramon Jimenez
Medical oncology, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
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 |
|---|---|---|---|---|---|
| France | 2023-06-27 | 2025-05-04 | 2023-08-08 | 2023-12-08 | |
| Hungary | 2023-05-08 | 2023-05-09 | 2023-12-08 | ||
| Poland | 2023-05-04 | 2023-05-09 | 2023-12-08 | ||
| Romania | 2023-05-04 | 2023-05-04 | 2023-12-08 | ||
| Spain | 2023-04-11 | 2023-04-26 | 2023-12-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 53 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | m5351-pd77v01mk3475a-p-app1611-protocol | 1 |
| Clinical study report (for publication) | m5351-pd77v01mk3475a-p-app1612-crf | 1 |
| Clinical study report (for publication) | m5351-pd77v01mk3475a-p-app1619-sap | 1 |
| Clinical study report (for publication) | m5351-pd77v01mk3475a-p-csr-body | 1 |
| Protocol (for publication) | D1 _Protocol_2022-501506-36-00_for pub | 03R |
| Protocol (for publication) | D1_Protocol_2022-501506-36-00_for pub | 00R |
| Protocol (for publication) | D1_PSP_for pub | 01R |
| Protocol (for publication) | D4_Copyright statement_EN_SM12_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements and Informed Consent Procedure_HUN_for publication | 12Nov2022 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and Informed Consent Procedure_ESP_Spanish_for publication | 21OCT2022 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and Informed Consent Procedure_FRA_French_for publication | 03MAY2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and Informed Consent Procedure_POL_Polish English_for publication | 27OCT2022 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and Informed Consent Procedure_ROU_Romanian_for publication | 24Nov2022 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_FRA_FR_for pub | 00.1 |
| Subject information and informed consent form (for publication) | L_ICF_Optional nursing_HUN_Hungarian_for publication | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ESP_Spanish_for publication | 18NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FRA_French_for publication | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_HUN_Hungarian_for publication | 16NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_POL_Polish_for publication | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ROU_EN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ROU_RO_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_HUN_Hungarian_for publication | 16NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ESP_Spanish_for publication | 18NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_FRA_for publication | 22NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_HUN_Hungarian_for publication | 16NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_POL_PL_SM10_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ROU_English_for publication | 23NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ROU_Romanian_for publication | 23NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_ROU_EN_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_ROU_RO_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM12_for pub | AM03v3.02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM10_for pub | AM02v2.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_SM12_for pub | AM03v3.02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM12_for pub | AM03v3.02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_EN_SM12_for pub | AM03v3.02 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_RO_SM12_for pub | AM03v3.02 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional nursing_ESP_Spanish_for publication | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional nursing_ESP_Spanish_for publication_ | 29NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional nursing_FRA_French_for publication | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional nursing_POL_Polish_for publication | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional pregnant partner_HUN_Hungarian_for publication | 17NOV2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add reimbursement_ROU_EN_SM10_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add reimbursement_ROU_RO_SM10_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_nursing_ROU_EN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_nursing_ROU_RO_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_HUN_HU_for pub | 2 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501506-36_ESP_ES_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501506-36_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501506-36_FRA_FR_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501506-36_HUN_HU_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501506-36_POL_PL_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-501506-36_ROU_RO_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-501506-36_ROU_EN_for pub | outofscope |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-30 | Spain | Acceptable 2023-04-04
|
2023-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-05-11 | Spain | Acceptable 2023-06-21
|
2023-06-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-22 | Spain | Acceptable 2024-01-30
|
2024-01-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-03-07 | Spain | Acceptable 2024-05-10
|
2024-05-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-06-25 | Spain | Acceptable 2024-08-06
|
2024-08-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-16 | Spain | Acceptable 2025-03-03
|
2025-03-04 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-02 | Spain | Acceptable 2025-03-03
|
2025-04-02 |
| 8 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-04-08 | Acceptable | 2025-05-17 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-10 | Spain | Acceptable | 2025-06-10 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-20 | Spain | Acceptable | 2025-08-20 |
| 11 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-12-05 | Spain | Acceptable 2026-02-25
|
2026-02-26 |