Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruitment pending
Participants planned
596
Countries
10
Sites
64
EGFR-mutated Non-small Cell Lung Cancer
Phase 2 : To determine the RP3D for iza-bren to advance to Stage 2 (Phase 3) of the study. Phase 3: To compare the progression-free survival of iza-bren at RP3D vs platinum-based chemotherapy in participants with advanced EGFRmt NSCLC cancer and disease progression after any 3rd generation TKIs
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-01-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521908-22-00
- WHO UTN
- U1111-1321-3429
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Pharmacokinetic, Dose response, Efficacy
Phase 2 : To determine the RP3D for iza-bren to advance to Stage 2 (Phase 3) of the study.
Phase 3: To compare the progression-free survival of iza-bren at RP3D vs platinum-based chemotherapy in participants with advanced EGFRmt NSCLC cancer and disease progression after any 3rd generation TKIs
Secondary objectives 1
- To compare the overall survival of iza-bren at RP3D vs platinum-based chemotherapy in participants with advanced EGFRmt NSCLC cancer and disease progression after any 3rd generation TKIs.
Conditions and MedDRA coding
EGFR-mutated Non-small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and partners/clinical-trials-and-research/disclosure-commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Non-squamous NSCLC, not amenable to treatment in curative intent.
- Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
- Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
- Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).
Exclusion criteria 3
- Inadequate organ function and/or bone marrow reserve.
- Leptomeningeal metastases or spinal cord compression.
- Poorly controlled systemic medical conditions.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2: RP3D determined based on the totality of safety, tolerability, efficacy, and PK/pharmacodynamic data
- Phase 3: progression-free survival by RECIST v1.1 per Blinded Independent Central Review.
Secondary endpoints 3
- Phase 2: Overall Survival by RECIST v1.1 per Blinded Independent Central Review
- Phase 2: Progression-Free Survival rates by RECIST v1.1 per Blinded Independent Central Review
- Phase 3: overall survival (OS).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11574214 · Product
- Active substance
- Izalontamab Brengitecan
- Substance synonyms
- BL-B01D1, Izalontamab conjugated to (3RS)-1-[(4S,13S,21S)-13-benzyl-1-carboxy-22-{[(1S,9S)-9-ethyl-5-fluoro-9-hydroxy-4-methyl-10,13-dioxo-2,3,9,10,13,15-hexahydro-1H,12H-benzo[de]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-1-yl]amino}-21-methyl-5,8,11,14,17,22-hexaoxo-20-oxa-2,6,9,12,15,18-hexaazadocosan-4-yl]-2,5-dioxopyrrolidin-3-yl, SI-B001 conjugated to EX0115, BMS986507
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/Kg milligram(s)/kilogram
- Max total dose
- 9999 mg/kg milligram(s)/kilogram
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- SYSTIMMUNE INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 3
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labeled and repackaged.
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labeled and repackaged.
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 9999 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labeled and repackaged.
Auxiliary 1
SUB16451MIG · Substance
- Active substance
- Pegfilgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The product will be over-labeled and repackaged.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, Data management |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Other |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Illumina Inc. ORG-100049125
|
San Diego, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
Locations
10 EU/EEA countries · 64 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 15 | 5 |
| France | Authorised, recruitment pending | 20 | 10 |
| Germany | Authorised, recruitment pending | 30 | 11 |
| Greece | Authorised, recruitment pending | 12 | 4 |
| Italy | Authorised, recruitment pending | 25 | 7 |
| Netherlands | Authorised, recruitment pending | 11 | 3 |
| Norway | Authorised, recruitment pending | 9 | 3 |
| Poland | Authorised, recruitment pending | 11 | 3 |
| Romania | Authorised, recruitment pending | 24 | 8 |
| Spain | Authorised, recruitment pending | 36 | 10 |
| Rest of world
India, Canada, China, Chile, Singapore, United Kingdom, Colombia, Korea, Republic of, Switzerland, Taiwan, Mexico, Thailand, Japan, United States, Argentina
|
— | 403 | — |
Investigational sites
Vitaz
Pulmonary and Infectious Disease, Moerlandstraat 1, 9100, Sint-Niklaas
Universitair Ziekenhuis Gent
Respiratory Medicine/Thoracic Oncology, Corneel Heymanslaan 10, 9000, Gent
Chirec
Respiratory Diseases, Boulevard Du Triomphe 201, 1160, Brussels
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Thoracic Oncology and Interventional Pneumology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Ziekenhuis Aan De Stroom
Pulmonology, Oosterveldlaan 24, 2610, Antwerp
Les Hopitaux Universitaires De Strasbourg
Penumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Regional De Marseille
Thoracic Oncology, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology, Pavillon E, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 09
Centre Hospitalier Universitaire De Toulouse
Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Hopital Tenon
Pneumology, 4 Rue De La Chine, 75970, Paris Cedex 20
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical Oncology, 15 Rue Andre Boquel, 49100, Angers
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Nantes
Medical Oncology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hospices Civils De Lyon
Pneumology, 59 Boulevard Pinel, 69500, Bron
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Robert-Bosch-Krankenhaus (RBK), Auerbachstrasse 112, Bad Cannstatt, Stuttgart
Kliniken der Stadt Koeln gGmbH
Thoraxonkologie, Ostmerheimer Strasse 200, Merheim, Cologne
Klinikum Kassel GmbH
Hämatologie, Onkologie und Immunologie, Moenchebergstrasse 41-43, Fasanenhof, Kassel
Asklepios Klinik Gauting GmbH
Onkologisches Studienzentrum, Robert-Koch-Allee 2, 82131, Gauting
Universitaetsklinikum Schleswig-Holstein AöR
Medizinische Klinik II, Arnold-Heller-Strasse 3, Brunswik, Kiel
Klinikum Esslingen GmbH
Klinik für Kardiologie, Angiologie und Pneumologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin II, Albert-Einstein-Allee 23, Eselsberg, Ulm
Asklepios Kliniken Hamburg GmbH
MVZ Onkologie Barmbek, Ruebenkamp 220, 22291, Hamburg
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Klinik für Pneumologie, Lindenberger Weg 27, Buch, Berlin
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin IV, Flemmingstrasse 2, Altendorf, Chemnitz
Onkologie Donauwoerth (MVZ) GmbH
Onkologisches Zentrum Donauwörth, Neudegger Allee 10, Neudegger Siedlung, Donauwoerth
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Clinic of Aristotle University of Thessaloniki, Exochi, 570 10, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine, Oncology Unit & Laboratory, Messogion Avenue 152, 115 27, Athens
Theageneio Cancer Hospital
Pulmonological-Oncological Department, Simeonidi Alex 2, 546 39, Thessaloniki
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Propaedeutic department of Internal Medicine, Rimini 1, 124 61, Chaidari
AORN San Giuseppe Moscati Avellino
U.O. Oncology, Contrada Amoretta, 83100, Avellino
Istituto Europeo Di Oncologia S.r.l.
Thoracic Oncology Division, Via Giuseppe Ripamonti 435, 20141, Milan
Centro Di Riferimento Oncologico Di Aviano
S.0.C. Oncologia medica e dei tumori immuno-correlati, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliero Universitaria Parma
Medical Oncology, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SCDU _Medicai Oncology, Regione Gonzole 10, 10043, Orbassano
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Thoracic Medical Oncology, Via Mariano Semmola 52, 80131, Naples
Azienda Unita Sanitaria Locale Della Romagna
Dip Onco-Ematologico, Viale Vincenzo Randi 5, 48121, Ravenna
Ziekenhuis St Jansdal
Lung, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Netherlands Cancer Institute
Lung, Plesmanlaan 121, 1066 CX, Amsterdam
Amsterdam UMC Stichting
Lung, De Boelelaan 1117, 1081 HV, Amsterdam
Oslo University Hospital HF
Department of Oncology, Montebello, Ullernchausséen 70, Oslo
Vestre Viken HF
Department of Oncology, Dronninggata 28, 3004, Drammen
Helse Bergen HF
Thoracic Medicine, Jonas Lies Vei 65, 5021, Bergen
Szpitale Pomorskie Sp. z o.o.
Oddział Onkologii i Radioterapii, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Odział Wieloprofilowy Zachowawczy, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institutul Regional De Oncologie Iasi
Oncology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Centrul De Diagnostic Si Tratament Provita S.A.
Oncology, Bulevardul Dimitrie Pompeiu Nr 9-9a Iride Business Park Sector 2, 11273, Bucharest
Memorial Healthcare International S.R.L.
Oncology, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 108 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol EU CT 2025-521908-22-00_GR_Redacted | 1 |
| Protocol (for publication) | D1_Protocol_2025-521908-22-00_redacted | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1.1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_BE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL | 1.0 |
| Recruitment arrangements (for publication) | K2 Recruitment Material_PI-to-Patient Letter | 1 |
| Recruitment arrangements (for publication) | K2 Recruitment Material_Recruitment Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Patient Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Patient Letter_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_PI to Patient Letter_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Recruitment Brochure_RO | 1 |
| Subject information and informed consent form (for publication) | L1 CA244-0010_NO_SIS-ICF Main_V1_04Dec2025_nor_Track changes | 1 |
| Subject information and informed consent form (for publication) | L1 CA244-0010_NO_SIS-ICF Optional Samples_V1_04Dec2025_nor_Track changed | 1 |
| Subject information and informed consent form (for publication) | L1 CA244-0010_NO_SIS-ICF Pregnant Partner_V1_04Dec2025_nor_Track Changed | 1 |
| Subject information and informed consent form (for publication) | L1 CA244-0010_NO_SIS-ICF Pregnant Patient_V1_04Dec2025_nor_Track changed | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Dose Switch for Phase 2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Optional Samples_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-ICF Pregnant Patient_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_Patent Facing documents_Questionnaire_EORTC-QLQ-F17_FR | 1 |
| Subject information and informed consent form (for publication) | L1_Patent Facing documents_Questionnaire_EQ-5D-5L_FR | 1 |
| Subject information and informed consent form (for publication) | L1_Patent Facing documents_Questionnaire_FACIT_FR | 1 |
| Subject information and informed consent form (for publication) | L1_Patent Facing documents_Questionnaire_NQT_FR | 1 |
| Subject information and informed consent form (for publication) | L1_Patent Facing documents_Questionnaire_NSCLC-SAQ_FR | 1 |
| Subject information and informed consent form (for publication) | L1_Patent Facing documents_Questionnaire_PRO-CTCAE_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Dose Switch_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Dose Switch_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose Switch IC_DU-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose Switch IC_EN-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose Switch IC_FR-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose switch_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose Switch_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose Switch_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose Switch_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Dose Switch_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Future Research_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Sample Collection_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Travel Reimbursement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main IC_DU-BE_For Publication_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main IC_EN-BE_For Publication_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main IC_FR-BE_For Publication_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection Protocol _PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional sample_DU-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional sample_EN-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional sample_FR-BE_For Publication_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_redacted_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Future Research_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional_Sample Collection_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_PL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_DU-BE_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_EN-BE_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR-BE_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_IT_Redatto | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose switch_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional sample collection_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_sponsor statement_BE | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Optional Future Research_PL_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin Accord IE | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed Accord EMA | 13 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin Fresenius Kabi | N/A |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis EU CT 2025-521908-22_PL | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis EU CT 2025-521908-22-00_GR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-521908-22_ES | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-521908-22_IT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-521908-22_NO | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-521908-22-00_EN | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521908-22_DU-BE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521908-22_FR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521908-22_FR-BE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521908-22_GER-BE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521908-22_NL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521908-22_RO | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-12 | Spain | Acceptable with conditions 2026-01-19
|
2026-01-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-28 | Acceptable with conditions 2026-01-19
|
2026-01-28 |