Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
99
Countries
5
Sites
16
Advanced Non-Small Cell Lung Cancer
To assess the efficacy of each treatment by evaluation of objective response rate.
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Sep 2019 → ongoing
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2023-504624-25-00
- EudraCT number
- 2018-003974-29
- ClinicalTrials.gov
- NCT03944772
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the efficacy of each treatment by evaluation of objective response rate.
Secondary objectives 3
- To assess the efficacy of each treatment by evaluation of tumour response and overall survival: tumour response (Progression-free survival, Duration of response) and Overall survival.
- To assess the pharmacokinetics (PK) of each treatment: Plasma/Serum concentrations of specific agents at selected time points.
- To assess the safety and tolerability of each treatment.
Conditions and MedDRA coding
Advanced Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Modules Study is modular in design, consisting of biomarker matched & biomarker non-matched cohorts
|
Not Applicable | None | Module 7: Etoposide + Carboplatin/Cisplatin + Durvalumab: The patients in this group will receive platinum-containing doublet (etoposide + carboplatin or cisplatin) taken in combination with durvalumab. Module 9: Osimertinib + Selumetinib: The patients in this group will receive osimertinib taken in combination with selumetinib. Module 10: Osimertinib + Datopotamab deruxtecan: The patients in this group will receive osimertinib taken in combination with datopotamab deruxtecan. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- NSCLC with the following features: (a) Locally advanced or metastatic disease (ie, advanced NSCLC) not amenable to curative surgery or radiotherapy at study entry. (b) Histologically or cytologically confirmed adenocarcinoma of the lung (patients with mixed histology are eligible if adenocarcinoma is the predominant histology) harboring EGFR mutation(s) known to be associated with EGFR TKI sensitivity at diagnosis. (c) Received only one line of therapy, with single-agent osimertinib, for advanced NSCLC, with clinical benefit as judged by investigator discretion. (Note: a ‘line’ of therapy is defined as a daily anti-cancer treatment administered for >14 days, or a single infusion of an intravenous anti-cancer treatment. For instance, patients who have had <14 days of a first- or second- generation TKI prior to osimertinib, and stopped due to adverse events, would be eligible to enter this study, see also exclusion criteria 5). Patients previously treated adjuvantly or neo-adjuvantly are eligible per exclusion criterion 5. (d) Evidence of radiological disease progression on first-line monotherapy with osimertinib 80 mg po QD.
- Suitable for a mandatory biopsy defined as having an accessible tumor; by whichever modality the site uses and, ideally, confirmed by the person who will perform the procedure; and a stable clinical condition that will allow the patient to tolerate the procedure. The biopsy should be performed within 60 days of the planned first dose of study treatment.
- Patients must have measurable disease per RECIST 1.1, as defined by at least 1 lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter (except lymph nodes which must have a short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), which is suitable for accurate repeated measurements. Previously irradiated lesions or a lesion in the field of radiation should not be used as measurable disease unless the lesion(s) has/have demonstrated unequivocal disease progression by RECIST 1.1. Target lesions should not be used for the baseline tumour biopsy, unless there are no other lesions suitable for biopsy and they fulfil requirements.
- Adequate coagulation parameters, defined as: International Normalisation Ratio (INR) < 1.5 × upper limit of normal (ULN) and activated partial thromboplastin time < 1.5 × ULN unless patients are receiving therapeutic anti-coagulation which affects these parameters.
Exclusion criteria 6
- Patients whose disease has progressed within the first 3 months of osimertinib treatment (refractory to osimertinib treatment).
- Patients must not have experienced a toxicity(-ies) that led to permanent discontinuation or dose reduction of prior osimertinib. (a) Patients who had dose reductions in the past, but were receiving a full dose of osimertinib at the time of pre-screening should be discussed with the Study Physician.
- Any unresolved toxicities from prior osimertinib treatment greater than CTCAE Grade 1 at the time of starting study treatment.
- Patients should not have discontinued osimertinib >60 days prior to the first dose of study treatment.
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: a) Absolute neutrophil count < 1.5 × 109/L. b) Platelet count < 100 × 109/L. c) Haemoglobin < 9 g/dL. d) Alanine transaminase (ALT) > 2.5 × ULN. e) Aspartate aminotransferase (AST) > 2.5 × ULN. f) Total bilirubin (TBL) > 1.5 × ULN, or > 3 × ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinaemia).
- Creatinine clearance (CrCl) < 50 mL/min, calculated using Cockcroft-Gault equation (Cockcroft and Gault 1976) or 24-hour urine collection.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess the efficacy of each treatment by evaluation of objective response rate - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) • Objective response rate (ORR)
Secondary endpoints 3
- To assess the efficacy of each treatment by evaluation of tumour response and overall survival Overall survival (OS) - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1): • Progression-free survival (PFS) • Duration of response (DoR)
- To assess the pharmacokinetics (PK) of each treatment: plasma/serum concentrations will be measured.
- To assess the safety and tolerability of each treatment - • Adverse events/serious adverse events (AEs/SAEs): • Physical examinations • Laboratory findings • Vital signs • Electrocardiogram (ECG). • Left ventricular ejection fraction (LVEF)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- INTRAVENOUS INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9684738 · Product
- Active substance
- Datopotamab Deruxtecan
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 6 mg/Kg milligram(s)/kilogram
- Max total dose
- 00 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- DAIICHI SANKYO, INC.
- Paediatric formulation
- No
- Orphan designation
- No
TAGRISSO 80 mg film-coated tablets
PRD4954972 · Product
- Active substance
- Osimertinib
- Substance synonyms
- AZD9291
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XE35 — -
- Marketing authorisation
- EU/1/16/1086/004
- MA holder
- ASTRAZENECA AB
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical tablets are plain on both sides and packed in HDPE bottles, while the commercial tablets are debossed with a commercial image and packed in aluminium blisters. The supply chain is different for commercial and clinical product.
TAGRISSO 40 mg film-coated tablets
PRD4954971 · Product
- Active substance
- Osimertinib
- Substance synonyms
- AZD9291
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EB04 — -
- Marketing authorisation
- EU/1/16/1086/003
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical tablets are plain on both sides and packed in HDPE bottles, while the commercial tablets are debossed with a commercial image and packed in aluminium blisters. The supply chain is different for commercial and clinical product.
PRD9025878 · Product
- Active substance
- Selumetinib
- Substance synonyms
- AZD6244
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EE04 — -
- Marketing authorisation
- EU/1/21/1552/002
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/18/2050
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC28 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6487529 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/005
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6483369 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6487527 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6487528 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/004
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6483619 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mycophenolate Mofetil Accord 250 mg capsules
PRD391904 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- PA 2315/064/001
- MA holder
- ACCORD HEALTHCARE IRELAND LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
5 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 15 | 3 |
| Netherlands | Ongoing, recruitment ended | 13 | 4 |
| Norway | Ended | 8 | 3 |
| Spain | Ended | 7 | 5 |
| Sweden | Ongoing, recruitment ended | 2 | 1 |
| Rest of world
Japan, United States, Korea, Republic of
|
— | 54 | — |
Investigational sites
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Oncologia Clinica Sperimentale Toraco-Polmonare, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncologia, Regione Gonzole 10, 10043, Orbassano
Istituto Oncologico Veneto
Oncology 2, Via Gattamelata 64, 35128, Padova
Stichting Amsterdam UMC
Afdeling Medische Oncologie, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Afdeling Oncologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Academisch Ziekenhuis Maastricht
longziekten, P Debyelaan 25, 6229 HX, Maastricht
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Thoraxoncologie, Plesmanlaan 121, 1066 CX, Amsterdam
St. Olavs Hospital HF
Onkologisk avdeling, Prinsesse Kristinas G. 3, 7030, Trondheim
Oslo University Hospital HF
Onkologisk avdeling, Montebello, Ullernchausséen 70, Oslo
Vestre Viken HF
Onkologisk avdeling, Dronninggata 28, 3004, Drammen
Hospital Universitario La Paz
Oncología, Paseo De La Castellana 261, 28046, Madrid
Hospital De La Santa Creu I Sant Pau
Oncología, Carrer De San Quinti 89, 08041, Barcelona
Hospital Clinic De Barcelona
Oncología, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario A Coruna
Oncología, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba Sn, 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 |
|---|---|---|---|---|---|
| Italy | 2022-11-15 | 2025-07-04 | 2022-11-25 | 2023-09-22 | |
| Netherlands | 2019-11-13 | 2020-05-28 | 2023-07-20 | ||
| Norway | 2019-11-05 | 2025-04-14 | 2019-12-18 | 2023-09-12 | |
| Spain | 2019-09-26 | 2024-11-04 | 2019-10-08 | 2023-08-01 | |
| Sweden | 2019-12-03 | 2020-05-04 | 2023-08-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol core_2023-504624-25-00_redacted | 7.0 |
| Protocol (for publication) | D1_Protocol M10_2023-504624-25-00_redacted | 7.0 |
| Protocol (for publication) | D1_Protocol M7_2023-504624-25-00_redacted | 7.0 |
| Protocol (for publication) | D1_Protocol M9_2023-504624-25-00_redacted | 7.0 |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements_CTIS Blank Document | NA |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements_CTIS Blank Document | NA |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements_CTIS Blank Document | NA |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements_CTIS Blank Document | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Placeholder_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_Mod 10_NL_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_Mod 7_NL_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_Mod 9_NL_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_SE | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_TBP_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pre-screening_NL_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF Module 10_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF Module 7_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF Module 9_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF_Module 10_ES_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF_Module 7_ES_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF_Module 9_ES_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF for treatment beyond progression_IT | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NO_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SE_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_IT | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partners_NO | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnat Partner ICF_ES | 4.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_ Addendum_NO | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_carboplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_cisplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_etoposide | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-504624-25-00_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_ENG_2023-504624-25 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_ES_2023-504624-25 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_IT_2023-504624-25 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_NLD_2023-504624-25 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_NO_2023-504624-25 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_SE_2023-504624-25 | 1.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | Norway | Acceptable 2024-08-13
|
2024-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-27 | Norway | Acceptable 2024-12-02
|
2024-12-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-26 | Norway | Acceptable 2024-12-02
|
2025-02-26 |