Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
327
Countries
9
Sites
79
Non-Small Cell Lung Cancer
To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of PFS by BICR in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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
- 28 Mar 2023 → ongoing
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2024-511169-12-00
- EudraCT number
- 2021-006374-24
- ClinicalTrials.gov
- NCT05261399
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety, Pharmacogenomic, Pharmacogenetic, Efficacy, Therapy, Pharmacokinetic
To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of PFS by BICR in participants with EGFR mutated, MET-overexpressed and/or amplified,
locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Secondary objectives 9
- To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of: 1) OS (MET-overexpressed and/or amplified)
- PFS by BICR (MET-overexpressed by IHC)
- OS (MET-overexpressed by IHC)
- PFS by Investigator (MET-overexpressed and/or amplified)
- ORR, DoR, DCR, TDT or death, and tumour shrinkage, (METoverexpressed and/or amplified)."
- To assess participant-reported pulmonary core symptoms of NSCLC.
- To evaluate the PK of savolitinib.
- To evaluate the safety and tolerability of savolitinib in combination with osimertinib versus platinum doublet chemotherapy.
- To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy in terms of BICRassessed CNS endpoints in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib
Conditions and MedDRA coding
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomised, open-label study to investigate the efficacy and safety of savolitinib and osimertinib Approximately 324 participants who have MET-overexpressed and/or amplified tumour status will be randomly assigned in a ratio of 1:1 to receive oral treatment with savolitinib plus osimertinib or platinum-based doublet chemotherapy followed by pemetrexed maintenance.
|
Randomised Controlled | Single | [{"id":144313,"code":4,"name":"Analyst"}] | Group A Savolitinib + Osimertinib: There is an opportunity to enhance the treatment with the combination of EGFR and MET inhibition for patients with EGFR mutated MET-positive NSCLC following progression on Osimertinib Group B pemetrexed + cisplatin or carboplatin: The platinum-based doublet chemotherapy arm in this study will enable direct comparison of the efficacy and safety of savolitinib in combination with osimertinib with the current SoC. |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-002627-PIP01-19
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
- Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
- Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
- Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
- Mandatory provision of FFPE tumour tissue.
- MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
- Measurable disease as defined by RECIST 1.1.
- Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
- ECOG performance status of 0 or 1.
Exclusion criteria 11
- Squamous NSCLC, and small cell lung cancer.
- Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD.
- Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
- Prior or current treatment with savolitinib or another MET inhibitors.
- Spinal cord compression or brain metastases, unless asymptomatic and are stable.
- History or active leptomeningeal carcinomatosis.
- Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL.
- Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals.
- History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement.
- Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS as defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause in participants with centrally confirmed MET IHC+ and/or MET FISH+ status (FAS). The comparison will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST 1.1 progression.
Secondary endpoints 9
- Overall survival defined as time from randomisation until the date of death due to any cause.
- Progression-free survival defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause in centrally confirmed MET IHC+ population of FAS (FAS-IHC+).
- Overall survival defined as time from randomisation until the date of death due to any cause in FAS-IHC+.
- Progression-free survival defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause in centrally confirmed MET IHC+ population of FAS (FASIHC+).
- A/ Objective response rate will be based on BOR defined as the proportion of participants who have BOR of a CR or PR, as determined by BICR per RECIST 1.1. B/ Duration of response defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR, or death in the absence of disease progression. C/Disease control rate defined as the proportion of participants who have BOR of a CR, PR, or stable disease [...]
- A/ TTD in pulmonary core symptoms (dyspnoea, cough, and chest pain) as measured by the questionnaire. B/TTD is defined as the time from randomisation until the date of deterioration.
- Plasma concentrations of savolitinib and its metabolites in the PK Analysis Set.
- Safety and tolerability will be evaluated in terms of AEs, SAEs, discontinuation rate due to AEs and deaths; clinical chemistry/haematology including LFTs; ECHOs/MUGAs, ECGs, ECOG performance status and vital signs in the Safety Analysis Set.
- CNS PFS, defined as the time from randomisation until the date of CNS progression assessed per CNS modified RECIST v1.1 by BICR or death in the FAS population. • CNS ORR defined as the proportion of participants who have a BOR in the CNS by BICR assessment in the cFAS population. • CNS DoR defined as the time from the date of first documented response in the CNS until the date of objective CNS progression as assessed by BICR or death in the absence of disease progression in the cFAS population.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
TAGRISSO 80 mg film-coated tablets
PRD3702398 · 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
- 1680 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XE35 — -
- Marketing authorisation
- EU/1/16/1086/002
- 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, whereas the commercial tablets are debossed with a commercial image and packed in aluminum blisters. The acceptance criteria for the assay of the drug product , assigned shelf life and sites for packing and QP release are also different for the clinical versus commercial product.
PRD10818121 · Product
- Active substance
- Savolitinib
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 12600 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
TAGRISSO 40 mg film-coated tablets
PRD3702399 · Product
- Active substance
- Osimertinib
- Substance synonyms
- AZD9291
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 840 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EB04 — -
- Marketing authorisation
- EU/1/16/1086/001
- 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, whereas the commercial tablets are debossed with a commercial image and packed in aluminum blisters. The acceptance criteria for the assay of the drug product , assigned shelf life and sites for packing and QP release are also different for the clinical versus commercial product.
Comparator 13
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
PRD8505445 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/006
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
PRD8505444 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/005
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD2433080 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(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
- Yes
- Modification description
- packaging, labeling
ALIMTA 100 mg powder for concentrate for solution for infusion
PRD2426372 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/002
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
PRD8505443 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/004
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
PRD8505446 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/007
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
Carboplatin 10 mg/ml concentrate for solution for infusion
PRD2005389 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- PL 20075/0028
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labeling, packaging
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD669106 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- 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
- Yes
- Modification description
- packaging, labeling
CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung
PRD1972920 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 46298.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labeling, packaging
Cisplatine Teva 1 mg/ml concentraat voor oplossing voor infusie.
PRD3759829 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE331913
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
Cisplatine Teva 1 mg/ml concentraat voor oplossing voor infusie.
PRD3752346 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE331931
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD662245 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 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
- Yes
- Modification description
- packaging, labeling
Cisplatine Teva 1 mg/ml concentraat voor oplossing voor infusie.
PRD3752946 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- BE331922
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- packaging, labeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Center
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 10, Code 11, Code 12, Code 13, Other, Code 2, Laboratory analysis, Code 5, Data management, E-data capture, Code 8, Code 9 |
Locations
9 EU/EEA countries · 79 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 2 | 1 |
| Belgium | Ongoing, recruitment ended | 6 | 7 |
| Bulgaria | Ongoing, recruitment ended | 3 | 1 |
| France | Ongoing, recruitment ended | 18 | 15 |
| Germany | Ongoing, recruitment ended | 12 | 10 |
| Greece | Ongoing, recruitment ended | 7 | 8 |
| Italy | Ongoing, recruitment ended | 18 | 17 |
| Poland | Ongoing, recruitment ended | 9 | 3 |
| Spain | Ongoing, recruitment ended | 12 | 17 |
| Rest of world
Turkey, Korea, Republic of, Canada, Argentina, United Kingdom, China, Japan, Hong Kong, Malaysia, Brazil, Australia, Vietnam, Israel, United States, Chile, Taiwan, Switzerland, Thailand, Singapore, Philippines
|
— | 240 | — |
Investigational sites
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Universitatsklinik fuer Innere Medizin III der PMU, Muellner Hauptstrasse 48, 5020, Salzburg
CHU Helora
Oncology, Boulevard President Kennedy 2, 7000, Mons
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Vitaz
Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Algemeen Ziekenhuis Delta
Oncology, Deltalaan 1, 8800, Roeselare
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
Multi-profile Hospital for Active Treatment Heart and Brain EAD
First department of medical oncology, Pierre Curie Street 2, 5804, Pleven
Assistance Publique Hopitaux De Paris
Oncologie Médicale, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Regional De Marseille
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Institut Curie
Oncologie Médicale, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Poitiers
Oncologie Médicale, 2 Rue De La Miletrie, 86000, Poitiers
Hospital Foch
Oncologie Médicale, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Regional Et Universitaire De Brest
Institut de Cancerologie et Hematologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier De Saint-Quentin
Pneumologie, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Centre Hospitalier Universitaire De Rennes
Pneumologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire D'Angers
Pneumologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire Rouen
Pneumologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Nantes
Oncologie Médicale, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Bordeaux
Oncologie Médicale, 1 Rue Jean Burguet, 33000, Bordeaux
Centr Georges Francois Leclerc
Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Les Hopitaux Universitaires De Strasbourg
Pneumologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Intercommunal Creteil
Pneumologie, 40 Avenue De Verdun, 94000, Creteil
Waldburg-Zeil Akutkliniken GmbH & Co. KG
Fachkliniken Wangen Klinik für Pneumologie, Am Vogelherd 14, 88239, Wangen Im Allgaeu
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
NA, Dueesbergweg 128, Dueesberg, Muenster
Charite Universitaetsmedizin Berlin KöR
Lungentumorambulanz, Südring 9, Augustenburger Platz 1, Wedding, Berlin
HELIOS Klinikum Emil von Behring GmbH
Lungenklinik Heckeshorn, Walterhoeferstrasse 11, Zehlendorf, Berlin
Muenchen Klinik gGmbH
Klinik für Pneumologie und pneumologische Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
Lungenfachklinik Immenhausen
Onkologische Ambulanz, Robert-Koch-Straße 3, 34376, Immenhausen
SLK-Kliniken Heilbronn GmbH
Med. Klinik II, Onkologie, Geisshoelzle 62, Hirrweiler, Loewenstein
Goethe University Frankfurt
Pneumology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Asklepios Klinik Gauting GmbH
Onkologie, Robert-Koch-Allee 2, 82131, Gauting
Klinikum Chemnitz gGmbH
Onkologie/Pneumologie, Flemmingstrasse 2, Altendorf, Chemnitz
Thoracic General Hospital Of Athens I Sotiria
3rd Propaedeutic Internal Medicine Clinic & Research Unit- Oncology Unit, Messogion Avenue 152, 115 27, Athens
Bioclinic S.A.
Oncology Unit, Mitropoleos 86, 546 22, Thessaloniki
University General Hospital Of Heraklion
Department of Medical Oncology, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Larissa
Department of Medical Oncology, P. O. Box 1425, 411 10, Larissa
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Clinic & Research Unit- Oncology Unit, Rimini Street 1, 124 62, Athens
Theageneio Cancer Hospital
Pulmonary- Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
General University Hospital Of Patras
Oncology Department of Internal Medicine Clinic, Rio, 265 04, Patras
Henry Dunant Hospital Center
4th Oncology Clinic, 107 Mesogeion Avenue, 115 26, Athens
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Oncology, Via Monte Baldo 24, 37019, Peschiera Del Garda
AORN San Giuseppe Moscati Avellino
Oncology, Contrada Amoretta, 83100, Avellino
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
I.F.O. Istituti Fisioterapici Ospitalieri
Oncology, Via Elio Chianesi N 53, 00144, Rome
San Camillo Forlanini Hospital
Oncology, Circonvallazione Gianicolense 87, 00152, Rome
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
Oncology, Via Sant'Ambrogio Di Fiera 37, 31100, Treviso
Azienda Ospedaliero-Universitaria Di Cagliari
Oncology, Strada Statale 554 N. 1, 09042, Monserrato
Centro Di Riferimento Oncologico Di Aviano
Oncology, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncology, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncology, Via Santa Maria Di Costantinopoli 104, 80138, Naples
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Oncology, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero Universitaria Parma
Oncology, Viale Antonio Gramsci 14, 43126, Parma
Hospital Santa Maria Della Misericordia
Oncology, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliero Universitaria Di Modena
Oncology, Largo Del Pozzo 71, 41124, Modena
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncology, Via Piero Maroncelli 40, 47014, Meldola
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncology, Via Giacomo Venezian 1, 20133, Milan
Uniwersytecki Szpital Kliniczny W Bialymstoku
II Klinika Chorób Płuc, Raka Płuca i Chorób Wewnętrznych, Zurawia 14, 15-540, Bialystok
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii z pododdziałem chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Instytut Centrum Zdrowia Matki Polki
Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario De Badajoz
Oncology, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Alvaro Cunqueiro
Oncology, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Germans Trias I Pujol
Oncology, Carretera Canyet 1a Planta, 08916, Badalona
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
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 |
|---|---|---|---|---|---|
| Austria | 2023-06-15 | 2024-01-03 | 2025-09-12 | ||
| Belgium | 2023-03-28 | 2023-03-28 | 2025-09-12 | ||
| Bulgaria | 2023-05-04 | 2023-06-20 | 2025-09-12 | ||
| France | 2023-12-04 | 2023-12-27 | 2025-09-12 | ||
| Germany | 2023-09-06 | 2023-11-13 | 2025-09-12 | ||
| Greece | 2023-04-12 | 2023-05-24 | 2025-09-12 | ||
| Italy | 2023-07-19 | 2023-10-04 | 2025-09-12 | ||
| Poland | 2023-04-26 | 2023-09-18 | 2025-09-12 | ||
| Spain | 2023-03-31 | 2023-04-11 | 2025-09-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 127 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511169-12-00_redacted | 3.0 |
| Protocol (for publication) | D1_Protocol_GR_2024-511169-12-00_Redacted | 2.0 |
| Protocol (for publication) | D4_Patient Facing Documents_Placeholder | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements form | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements form_AT_English | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements form_BG_Bulgarian | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Form_FR_French | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE_English | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ES_English | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_GR_English | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT_English | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Advocacy Outreach | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach_AT_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach_BE_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach_BE_French | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach_BG_Bulgarian | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach_BG_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach_ES_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Advocacy Outreach_FR_French | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Advocacy Outreach_GR_Greek | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Outreach_IT_Italian | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_AT_German | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_BE_Dutch | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_BE_French | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_BG_Bulgarian | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_BG_English | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_ES_Spanish | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Brochure_FR_French | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Brochure_GR_Greek | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_IT_Italian | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Guide | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Study Website | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_AT_German | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_BE_Dutch | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_BE_French | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_BG_Bulgarian | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_BG_English | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Website_ES_Spanish | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Website_FR_French | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Website_GR_Greek | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study website_IT_Italian | 1.1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Video Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script_AT_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script_BE_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script_BE_French | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script_BG_Bulgarian | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script_BG_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script_ES_Spanish | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Video Script_FR_French | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Video Script_GR_Greek | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Script_IT_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum I to Main_ES_Spanish_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_ES_Spanish | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Privacy Notice and Consent for Screening_IT_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Privacy Notice and Consent_IT_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_Dutch_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_English_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_French_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BG_Bulgarian_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BG_English_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Spanish_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Greek_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Italian_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Polish_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Opt Genetic_BG_Bulgarian_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Opt Genetic_BG_English_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Opt Genetic_IT_Italian_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Genetic Research_GR_Greek_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Genetic_ES_Spanish_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Genetic_PL_Polish_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_BG_Bulgarian | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_BG_English | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_GR_Greek | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_IT_Italian | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_BE_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_BE_English_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_BE_French_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_BE_Dutch | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_BE_English | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_BE_French | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ICF_PL_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ES_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screen Part 1_IT_Italian_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screening Part 1_BG_Bulgarian_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screening Part 1_BG_English_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screening Part 1_PL_Polish_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screening Part I_ES_Spanish_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Screening_GR_Greek_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_DE_German_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_AT_German_Redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_German_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_French_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic Research_FR_French_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic_AT_German_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic_DE_German_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_AT_German | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FR_French | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partners_DE_German | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part 1_DE_German_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part 1_FR_French_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Screening Part I_AT_German_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Overview Investigators_AT_German | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin_ Accord | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin_Fresenius | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin_Stadapharm | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin_Teva | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin_Teva_be | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed_Accord | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed_Altima | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_2024-511169-12-00_AT_DE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_BG | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_DE-BE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_DE-DE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_EN | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_ES | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_FR-BE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_FR-FR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_GR-GR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511169-12-00_IT | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_NL-BE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511169-12-00_PL-PL | 1.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Italy | Acceptable 2024-07-26
|
2024-07-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-30 | Italy | Acceptable 2024-10-24
|
2024-10-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-16 | Acceptable 2024-10-24
|
2024-12-16 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-19 | Acceptable | 2025-02-14 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-24 | Italy | Acceptable | 2025-02-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-25 | Italy | Acceptable 2025-06-20
|
2025-06-20 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-14 | Acceptable 2025-06-20
|
2025-08-14 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-30 | Italy | Acceptable 2025-11-05
|
2025-11-06 |