Effect of study drug combined with chemotherapy in patients with locally advanced or metastatic lung cancer with mutated receptor responsible for epithelial growth (EGF-R) that progressed after the treatment with other drugs.

Start 3 Oct 2023 · Status Ongoing, recruitment ended · 3 EU/EEA countries · 23 sites · Protocol AK112-301

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 481

Countries 3

Sites 23

Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Key facts

Sponsor: Summit Therapeutics Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 3 Oct 2023 → ongoing
Decision date (initial): 2023-10-26
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Summit Therapeutics Sub, Inc.

External identifiers

EU CT number: 2023-504434-22-00
ClinicalTrials.gov: NCT06396065

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Pharmacokinetic, Efficacy

1) To compare overall survival (OS) in the Modified Intent-to-Treat (mITT) population
between AK112 combined with pemetrexed and carboplatin and placebo combined
with pemetrexed and carboplatin, in patients with locally advanced or metastatic nonsquamous
non-small cell lung cancer (NSCLC) with epidermal growth factor receptor
(EGFR) mutations who have progressed on or following EGFR tyrosine kinase
inhibitor (TKI) therapy.
2) To compare progression-free survival (PFS) assessed by the Independent Radiology
Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1, in the mITT population between AK112 combined with pemetrexed
and carboplatin and placebo combined with pemetrexed and carboplatin, in patients
with locally advanced or metastatic non-squamous NSCLC with EGFR mutations who
have progressed on or following EGFR TKI therapy.

Secondary objectives 4

To compare objective response rate (ORR) and duration of response (DoR), as assessed by IRRC based on RECIST v1.1, in the mITT population between AK112 combined with pemetrexed and carboplatin and placebo combined with pemetrexed and carboplatin, in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have progressed on or following EGFR TKI therapy
To compare the safety and tolerability of AK112 combined with pemetrexed and carboplatin and placebo combined with pemetrexed and carboplatin
To evaluate the pharmacokinetic (PK) profile of AK112 in combination with pemetrexed plus carboplatin
To evaluate the immunogenicity of AK112 combined with pemetrexed plus carboplatin

Conditions and MedDRA coding

Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Version	Level	Code	Term	System organ class
21.0	PT	10025124	Lung squamous cell carcinoma stage III	100000004864
21.0	PT	10025125	Lung squamous cell carcinoma stage IV	100000004864

Study design 2 periods

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Induction period A total of 4 cycles (21 days per cycle).	Randomised Controlled	Double	[{"id":164120,"code":1,"name":"Subject"},{"id":164119,"code":2,"name":"Investigator"}]	Group A: AK112 (20 mg/kg, every 3 weeks [Q3W]) plus pemetrexed (500 mg/m2, Q3W) plus carboplatin (AUC 5 mg/mL/min, Q3W) for a total of 4 cycles (21 days per cycle), Group B: Placebo (20 mg/kg, Q3W) plus pemetrexed (500 mg/m2, Q3W) plus carboplatin (AUC 5 mg/mL/min, Q3W) for a total of 4 cycles (21 days per cycle)
2	Maintenance Period Until intolerable toxicity develops or investigator judges there is no longer a clinical benefit (according to RECIST v1.1 using thorough judgment such as imaging evaluation and clinical condition), or the patient meets other criteria for termination of treatment, whichever occurs first.	Randomised Controlled	Double	[{"id":164122,"code":1,"name":"Subject"},{"id":164123,"code":2,"name":"Investigator"}]	Group A: AK112 (20 mg/kg, Q3W) plus pemetrexed (500 mg/m2, Q3W) will be continued until intolerable toxicity develops or investigator judges there is no longer a clinical benefit (according to RECIST v1.1 using thorough judgment such as imaging evaluation and clinical condition), or the patient meets other criteria for termination of treatment, whichever occurs first. Group B: placebo (Q3W) plus pemetrexed (500 mg/m2, Q3W) will be continued until intolerable toxicity develops or investigator judges there is no longer a clinical benefit (according to RECIST v1.1 using thorough judgment such as imaging evaluation and clinical condition), or the patient meets other criteria for termination of treatment, whichever occurs first.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Life expectancy ≥ 3 months
Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy
The tumor histology, cytology or blood test confirmed the presence of EGFR activating mutations before enrollment
Have previously received EGFR-TKI treatment and the treatment has failed
Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1
Major organ function prior to treatment meets the criteria defined in Protocol
Patients of childbearing potential must agree to use highly effective contraceptive measures

Exclusion criteria 15

Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma
There are reports confirming the existence of other driver gene mutations with known drug treatments
Subjects who received any prior treatments targeting the mechanism of tumor immunity
The subject has received systemic anti-tumor therapy other than EGFR-TKI
Currently enrolled in any other clinical study
Received EGFR-TKI treatment, palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose
Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels
Symptomatic central nervous system metastases
Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment
There is a history of major diseases 1 year prior to the first dose
Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
Received chest radiation therapy prior to the first dose
Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage
Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

OS in the mITT population
PFS assessed by IRRC based on RECIST v1.1 in the mITT population

Secondary endpoints 4

ORR (including DoR) assessed by IRRC based on RECIST v1.1 in the mITT Population
Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results
PK characteristics: AK112 serum drug concentration at different time points after AK112 administration
Immunogenicity assessment: number and percentage of patients with detectable anti-AK112 antibody (ADA).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

ivonescimab

PRD10296948 · Product

Active substance: Ivonescimab
Pharmaceutical form: INJECTION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 20 mg/kg milligram(s)/kilogram
Max total dose: 30 mg/kg milligram(s)/kilogram
Max treatment duration: 24 Month(s)
Authorisation status: Not Authorised
MA holder: SUMMIT THERAPEUTICS SUB, INC.
Paediatric formulation: No
Orphan designation: No

Placebo 1

Placebo to match AK112 (Ivonescimab) concentrate for solution for infusion. 10 mg/mL, 10 mL vial

N/A · Product

Other product name: N/A
Pharmaceutical form: N/A
ATC code: N/A — N/A
Marketing authorisation: N/A
MA holder: N/A
MA country: Iceland
Paediatric formulation: No

Auxiliary 18

Pemetrexed Ever Pharma 25 mg/ml concentrado para solución para perfusion.

PRD8727321 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: 85762
MA holder: EVER VALINJECT GMBH
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion

PRD3399796 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1057/002
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion

PRD3399795 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1057/001
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion

PRD3399797 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1057/003
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion

PRD6059781 · Product

Active substance: Pemetrexed Disodium
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1037/003
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Sandoz 500 mg Powder for concentrate for solution for infusion

PRD6061734 · Product

Active substance: Pemetrexed Disodium
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1037/002
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Sandoz 100 mg Powder for concentrate for solution for infusion

PRD6059780 · Product

Active substance: Pemetrexed Disodium
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1037/001
MA holder: SANDOZ GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Aurovit 25 mg/ml concentrado para solución para perfusión

PRD8720412 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/sq. meter
Max total dose: 500 mg/m2 milligram(s)/sq. meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: 82.771
MA holder: AUROVITAS SPAIN,S.A.U.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

ALIMTA 500 mg powder for concentrate for solution for infusion

PRD291536 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/sq. meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/04/290/001
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

ALIMTA 100 mg powder for concentrate for solution for infusion

PRD290939 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/sq. meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/04/290/002
MA holder: ELI LILLY NEDERLAND B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carboplatino Accord 10 mg/ml concentrado para solución para perfusión EFG

PRD2005427 · Product

Active substance: Carboplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 5 Other
Max total dose: 5 Other
Max treatment duration: 84 Day(s)
Authorisation status: Authorised
ATC code: L01XA02 — CARBOPLATIN
Marketing authorisation: 70707
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carboplatino Accord 10 mg/ml concentrado para solución para perfusión EFG

PRD2005428 · Product

Active substance: Carboplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 5 Other
Max total dose: 5 Other
Max treatment duration: 84 Day(s)
Authorisation status: Authorised
ATC code: L01XA02 — CARBOPLATIN
Marketing authorisation: 70707
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carboplatino Pharmacia 10 mg/ml concentrado para solución para perfusión EFG

PRD7814584 · Product

Active substance: Carboplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 5 Other
Max total dose: 5 Other
Max treatment duration: 84 Day(s)
Authorisation status: Authorised
ATC code: L01XA02 — CARBOPLATIN
Marketing authorisation: 62.123
MA holder: PHARMACIA NOSTRUM, S.A.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carboplatino Pharmacia 10 mg/ml concentrado para solución para perfusión EFG

PRD7814588 · Product

Active substance: Carboplatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 5 Other
Max total dose: 5 Other
Max treatment duration: 84 Day(s)
Authorisation status: Authorised
ATC code: L01XA02 — CARBOPLATIN
Marketing authorisation: 62.123
MA holder: PHARMACIA NOSTRUM, S.A.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.

PRD3636608 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1071/003
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Accord 100 mg powder for concentrate for solution for infusion.

PRD3636606 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1071/001
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.

PRD3636607 · Product

Active substance: Pemetrexed
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 500 mg/m2 milligram(s)/square meter
Max total dose: 500 mg/m2 milligram(s)/square meter
Max treatment duration: 24 Month(s)
Authorisation status: Authorised
ATC code: L01BA04 — -
Marketing authorisation: EU/1/15/1071/002
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carboplatino Teva 10 mg/ml Concentrado para solución para perfusión

PRD664512 · Product

Active substance: Carboplatin
Pharmaceutical form: INJECTION
Route of administration: INTRAVENOUS DRIP USE
Max daily dose: 5 Other
Max total dose: 5 Other
Max treatment duration: 84 Day(s)
Authorisation status: Authorised
ATC code: L01XA02 — CARBOPLATIN
Marketing authorisation: 65108
MA holder: TEVA PHARMA S.L.U.,
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Summit Therapeutics Inc.

Sponsor organisation: Summit Therapeutics Inc.
Address: 2882 Sand Hill Road Suite 106
City: Menlo Park
Postcode: 94025-7057
Country: United States

Scientific contact point

Organisation: Summit Therapeutics Inc.
Contact name: Medical Information

Public contact point

Organisation: Summit Therapeutics Inc.
Contact name: Medical Information

Locations

3 EU/EEA countries · 23 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruitment ended	10	5
Italy	Ongoing, recruitment ended	10	5
Spain	Ongoing, recruitment ended	25	13
Rest of world United States, United Kingdom, Canada, China	—	436	—

Investigational sites

France

5 sites · Ongoing, recruitment ended

Assistance Publique Hopitaux De Paris

Thoracic Oncology, 46 Rue Henri Huchard, 75877, Paris Cedex 18

Centre Hospitalier Intercommunal Creteil

Service pneumology, 40 Avenue De Verdun, 94000, Creteil

Centre Leon Berard

Medical Oncology, 28 Rue Laennec, 69008, Lyon

Institut Gustave Roussy

Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif

Institut Curie

Pneumology, 26 Rue D Ulm, 75005, Paris

Italy

5 sites · Ongoing, recruitment ended

I.F.O. Istituti Fisioterapici Ospitalieri

Medical Oncology 2, Via Elio Chianesi N 53, 00144, Rome

Universita' Campus Bio-medico Di Roma

Medical Oncology, Via Alvaro Del Portillo 200, 00128, Rome

Istituto Nazionale Dei Tumori

Oncology, Via Giacomo Venezian 1, 20133, Milan

European Institute Of Oncology S.r.l.

Thoracic Oncology Devision, Via Giuseppe Ripamonti 435, 20141, Milan

Azienda Ospedaliero Universitaria Parma

Oncology, Viale Antonio Gramsci 14, 43126, Parma

Spain

13 sites · Ongoing, recruitment ended

Hospital Universitario Lucus Augusti

Medical Oncology, Calle Ulises Romero 1, 27003, Lugo

Hospital Universitario Ramon Y Cajal

Oncology Department, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid

Hospital Universitario Regional De Malaga

Oncology, Avenida De Carlos De Haya S/n, 29010, Malaga

Hospital Universitario Fundacion Jimenez Diaz

Oncology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital General Universitario Gregorio Maranon

Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid

Hospital Universitari Germans Trias I Pujol

Oncology, Carretera Canyet 1a Planta, 08916, Badalona

Area Sanitaria Da Coruna E Cee

Medical Oncology, Lugar Jubias De Arriba Num 84, 15006, A Coruna

Hospital Universitario La Paz

Oncología Médica, Paseo Castellana 261, 28046, Madrid

Complejo Hospitalario Universitario Insular Materno Infantil

Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria

Hospital Universitario Virgen De Valme

Medical Oncology, Avenida Bellavista S/n, 41014, Sevilla

Hospital Clinico San Carlos

Medical Oncology, Planta Baja Sur 1, Pasillointerior, Madrid

Hospital Universitari Vall D Hebron

Medical Oncology Department, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Hospital Universitario Puerta De Hierro De Majadahonda

Medical Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start	Recruitment end
France	2024-01-22	2024-02-22	2024-08-20
Italy	2024-01-18	2024-02-28	2024-09-26
Spain	2023-10-03	2023-11-02	2024-09-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 64 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_ Protocol 2023-504434-22-00_redacted	2.2
Protocol (for publication)	D1_ Protocol synopsis_2023-504434-22-00_IT_redacted	2.3
Protocol (for publication)	D1_Protocol 2023-504434-22-00_SM_redacted	2.3
Protocol (for publication)	D1_SOC Protocol 2023-504434-22-00_redacted	2.3
Protocol (for publication)	D4_ Patient facing documents questionnaire_ENG	3
Protocol (for publication)	D4_ Patient facing documents questionnaire_ES	3
Protocol (for publication)	D4_ Patient facing documents questionnaire_IT	3
Protocol (for publication)	L2_Questionaire_FR	3.0
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF GDPR_ENG_redacted	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF GDPR_IT_redacted	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF main_ENG_redacted	4.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF main_ENG_redacted	4.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF main_ES_redacted	4.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF main_IT_redacted	4.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF Pregnant Partner_ENG_redacted	1.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF Pregnant Partner_ENG_redacted	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF Pregnant Partner_ES_redacted	1.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF Pregnant Partner_IT_redacted	2
Subject information and informed consent form (for publication)	L1_ SIS and ICF_GDPR_IT Redacted	3.2
Subject information and informed consent form (for publication)	L1_ SIS and ICF_GDPR_IT Redacted ENG	3.2
Subject information and informed consent form (for publication)	L1_ SIS and ICF_PP_FR Redacted	2.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_PP_FR Redacted ENG	2.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_PP_FR_EN_redacted	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF_PP_FR_redacted	1
Subject information and informed consent form (for publication)	L1_ SIS and ICF_Pregnant Partner_ESP Redacted	2.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_Pregnant Partner_ESP Redacted ENG	2.0
Subject information and informed consent form (for publication)	L1_ SIS and ICF_Pregnant Partner_IT Redacted	4.2
Subject information and informed consent form (for publication)	L1_ SIS and ICF_Pregnant Partner_IT Redacted ENG	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_EN_redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_ES_EN_redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ES_ENG_redacted	6
Subject information and informed consent form (for publication)	L1_SIS and ICF_ES_redacted	6
Subject information and informed consent form (for publication)	L1_SIS and ICF_ESP_ENG Redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ESP_Redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ESP_Redacted ENG	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_FR Redacted	6.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_FR Redacted ENG	6.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_FR_EN_redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_FR_ENG_redacted	5.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_FR_ENG_with administrative corrections_redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_FR_redacted	5.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_FR_with administrative corrections_redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_IT Redacted	7.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_IT Redacted ENG	7.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_IT_ENG_redacted	6
Subject information and informed consent form (for publication)	L1_SIS and ICF_IT_redacted	6
Subject information and informed consent form (for publication)	L2_ Master Participant Card_ES_redacted	1.0
Subject information and informed consent form (for publication)	L2_ Master Participant Card_FR_redacted	1
Subject information and informed consent form (for publication)	L2_ Master Participant Card_IT_redacted	1.0
Subject information and informed consent form (for publication)	L2_Bank card for patients_France_redacted	1
Subject information and informed consent form (for publication)	L2_Bank card for patients_Italy_redacted	1
Subject information and informed consent form (for publication)	L2_Bank card for patients_Spain_redacted	1
Summary of Product Characteristics (SmPC) (for publication)	G2_ SmPC AK112	1
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_2023-504434-22-00_ES_redacted	2.3
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_2023-504434-22-00_FR_redacted	2.3
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_2023-504434-22-00_IT_redacted	2.3
Synopsis of the protocol (for publication)	D1_ Protocol Synopsis_ENG 2023-504434-22-00_redacted	2.2
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_ES 2023-504434-22-00_redacted	2.2
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_FR 2023-504434-22-00_redacted	2.2
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_IT 2023-504434-22-00_redacted	2.2
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_2023-504434-22-00_ENG_redacted	2.3

Application history

13 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-04-06	Spain	Acceptable 2023-07-20	2023-07-24
2	SUBSTANTIAL MODIFICATION	SM-3	2023-08-04	Spain	Acceptable	2023-09-08
3	SUBSTANTIAL MODIFICATION	SM-4	2023-08-04		Acceptable	2023-10-17
4	SUBSEQUENT ADDITION OF MSC	APP-4	2023-08-04			2023-10-26
5	SUBSTANTIAL MODIFICATION	SM-5	2023-11-10	Spain	Acceptable 2024-01-29	2024-01-29
6	NON SUBSTANTIAL MODIFICATION	NSM-2	2024-02-20	Spain	Acceptable 2024-01-29	2024-02-20
7	SUBSTANTIAL MODIFICATION	SM-6	2024-02-28	Spain	Acceptable 2024-04-12	2024-04-12
8	NON SUBSTANTIAL MODIFICATION	NSM-5	2024-05-23	Spain	Acceptable 2024-04-12	2024-05-23
9	SUBSTANTIAL MODIFICATION	SM-8	2024-05-28	Spain	Acceptable 2024-07-24	2024-07-24
10	SUBSTANTIAL MODIFICATION	SM-9	2024-10-24	Spain	Acceptable 2024-12-03	2024-12-11
11	SUBSTANTIAL MODIFICATION	SM-10	2025-07-24	Spain	Acceptable	2025-09-05
12	SUBSTANTIAL MODIFICATION	SM-11	2025-09-26	Spain	Acceptable 2025-12-05	2025-12-10
13	SUBSTANTIAL MODIFICATION	SM-12	2025-12-23	Spain	Acceptable 2026-02-18	2026-02-20