Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
87
Countries
9
Sites
56
Non-Small Cell Lung Cancer
Phase 2: To evaluate the safety and tolerability of telisotuzumab adizutecan; To evaluate the efficacy of telisotuzumab adizutecan as measured by objective response (OR) per blinded independent central review (BICR); To select the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan; Phase 3: To evaluate the eff…
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie
External identifiers
- EU CT number
- 2025-521124-29-00
- ClinicalTrials.gov
- NCT07155187
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Efficacy
Phase 2: To evaluate the safety and tolerability of telisotuzumab adizutecan; To evaluate the efficacy of telisotuzumab adizutecan as measured by objective response (OR) per blinded independent central review (BICR); To select the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan; Phase 3: To evaluate the efficacy of telisotuzumab adizutecan compared with standard of care based on progression-free survival (PFS) per BICR assessment.
Secondary objectives 2
- Phase 2: To further evaluate the efficacy of telisotuzumab adizutecan as measured by PFS, duration of response (DoR), and disease control rate (DCR) per BICR, and overall survival (OS).
- Phase 2: To characterize the pharmacokinetics (PK) and immunogenicity of telisotuzumab adizutecan.
Conditions and MedDRA coding
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation as detected by an Federal Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care.
- Provide archived or recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2).
- Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
- Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
- Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
Exclusion criteria 2
- Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.
- Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR)
- Phase 3: Progression-Free Survival (PFS) as assessed by BICR
Secondary endpoints 9
- Phase 2 and 3: Overall Survival (OS) as assessed by BICR
- Phase 2: PFS as assessed by BICR
- Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1
- Phase 3: OR Assessed by BICR
- Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
- Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13)
- Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30
- Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11535908 · Product
- Active substance
- Telisotuzumab Adizutecan
- Substance synonyms
- ABBV-400, DC-1951796, Telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 10 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 13
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB176340 · Substance
- Active substance
- Osimertinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB176340 · Substance
- Active substance
- Osimertinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB193051 · Substance
- Active substance
- Amivantamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB193051 · Substance
- Active substance
- Amivantamab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Labcorp Central Laboratory Services Sàrl ORL-000005229
|
Geneva, Switzerland | Laboratory analysis |
| Clario ORL-000001443
|
United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Interactive response technologies (IRT) |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Cary, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
Locations
9 EU/EEA countries · 56 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 1 | 1 |
| Belgium | Ongoing, recruiting | 12 | 5 |
| France | Ongoing, recruiting | 6 | 8 |
| Germany | Ongoing, recruiting | 4 | 6 |
| Italy | Ongoing, recruiting | 9 | 10 |
| Netherlands | Ongoing, recruiting | 3 | 5 |
| Poland | Ongoing, recruiting | 7 | 7 |
| Portugal | Ongoing, recruiting | 6 | 6 |
| Spain | Ongoing, recruiting | 8 | 8 |
| Rest of world
Taiwan, China, Israel, United Kingdom, Australia, Japan, United States, Canada, Mexico, Brazil, Korea, Republic of, Serbia, Puerto Rico, Turkey
|
— | 31 | — |
Investigational sites
Stadt Wien Wiener Gesundheitsverbund
Klinik Floridsdorf - Abteilung fuer Innere Medizin und Pneumologie, Bruenner Strasse 68, Floridsdorf, Vienna
CHC MontLegia
Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
UZ Leuven
Respiratory Oncology Unit, Herestraat 49, 3000, Leuven
Jessa Ziekenhuis
Pneumology, Stadsomvaart 11, 3500, Hasselt
Grand Hopital De Charleroi
Oncology& Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional Et Universitaire De Brest
Oncology, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Universitaire De Montpellier
Thoracic Oncology, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Universitaire De Lille
Pulmonology and Thoracic Oncology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire Grenoble Alpes
Pole thorax et Vaisseaux - Unité d'Oncologie Thoracique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Institut De Cancerologie De L Ouest
Medical oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Regional De Marseille
Oncologie multidisciplinaire et innovations thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Universitaetsklinikum Koeln AöR
Oncology, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Jena KöR
Oncology, Am Klinikum 1, Lobeda, Jena
Thoraxklinik Heidelberg gGmbH
Oncology, Roentgenstrasse 1, Rohrbach, Heidelberg
University Medical Center Hamburg-Eppendorf
Oncology, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Wuerzburg AöR
Oncology, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Justus-Liebig-Universitaet Giessen
Oncology, Gaffkystrasse 5, 35392, Giessen
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Oncology, Via Santa Sofia 78, 95123, Catania
Ospedale Isola Tiberina Gemelli Isola
Oncology, Via Di Ponte Quattro Capi 39, 00186, Rome
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliera Universitaria Integrata Verona
Oncology, Piazzale Aristide Stefani 1, 37126, Verona
Fondazione IRCCS San Gerardo Dei Tintori
Oncology, Via Giovanbattista Pergolesi 33, 20900, Monza
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Oncology, Viale Vittorio Veneto 2, 61032, Fano
Azienda Ospedaliera Dei Colli
Oncology, Via Leonardo Bianchi, 80131, Naples
Centro Di Riferimento Oncologico Di Aviano
Oncology, Via Franco Gallini 2, 33081, Aviano
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
Oncology, Via Elio Chianesi N 53, 00144, Rome
Leids Universitair Medisch Centrum (LUMC)
Longziekten, Albinusdreef 2, 2333 ZA, Leiden
Radboud universitair medisch centrum Stichting
Longziekten, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Utrecht
Divisie Hart en Longen, Heidelberglaan 100, 3584 CX, Utrecht
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Longziekten, Plesmanlaan 121, 1066 CX, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Longziekten, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Oddzial Wieloprofilowy Zachowawczy, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Provita Centrum Medyczne Sp. z o.o.
NA, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Gyncentrum Sp. z o.o.
NA, Ul. Wojska Polskiego 8a, 41-208, Sosnowiec
Uniwersyteckie Centrum Kliniczne
Centrum Wsparcia Badan Klinicznych UCK, Osrodek Badan Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworow Pluca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Pratia S.A.
NA, Ul. Pana Tadeusza 2, 30-727, Cracow
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Hospital CUF Porto S.A.
Oncology, Estrada Da Circunvalacao N 14341, 4100-180, Porto
CCAB Centro Clinico Academico Braga Associacao
Oncology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santo Antonio E.P.E.
Oncology, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Matosinhos E.P.E.
Oncology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude Do Alto Ave E.P.E.
Pulmonology, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude De Loures-Odivelas EPE
Oncology, Avenida Carlos Teixeira 3, 2674-514, Loures
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1, 08208, Sabadell
Hospital Universitario Virgen De La Victoria
Oncologist, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
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 | 2026-02-25 | 2026-04-07 | |||
| Belgium | 2026-02-26 | 2026-03-10 | |||
| France | 2026-03-13 | 2026-03-26 | |||
| Germany | 2026-02-19 | 2026-03-12 | |||
| Italy | 2026-02-13 | 2026-03-31 | |||
| Netherlands | 2026-03-10 | 2026-03-11 | |||
| Poland | 2026-04-01 | 2026-04-08 | |||
| Portugal | 2026-02-13 | 2026-02-18 | |||
| Spain | 2026-03-03 | 2026-03-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 72 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m25713-protocol-public redacted_cci identified | 1.1 (EU) |
| Recruitment arrangements (for publication) | K1 M25-713 BE Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | K1 M25-713 FR Recruitment and ICF Procedures 23Sep2025_Public | 2.0 |
| Recruitment arrangements (for publication) | K1 M25-713 NL Recruitment and ICF Procedures_Public | 1.2 |
| Recruitment arrangements (for publication) | K1 M25-713 PL Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1 M25-713 PT Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M25-713 AT Recruitment and ICF procedure_public | 2 |
| Recruitment arrangements (for publication) | K1_M25-713 IT_EU CTR Recruitment and ICF Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_M25-713_DE_Recruitment and ICF Procedures_public | 1 |
| Recruitment arrangements (for publication) | K1_M25-713_ES__Recruitment and ICF procedures_Public | 2 |
| Recruitment arrangements (for publication) | K2 M25-713 FR Recruitment Brochure French_Public 29Aug2025 | 1.0 |
| Recruitment arrangements (for publication) | K2 M25-713 PT Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M25-713 AT Recruitment Brochure_public | 1.0 |
| Recruitment arrangements (for publication) | K2_M25-713_DE_Patient Recruitment Brochure_public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Addendum ICF Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Addendum ICF English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Addendum ICF French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Main ICF Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Main ICF English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Main ICF French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Other ICF Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Other ICF English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Other ICF French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Preg Part ICF Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Preg Part ICF English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 BE Preg Part ICF French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 FR Cont Treatment ICF French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 FR Main ICF French_Public Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 M25-713 FR Preg Part ICF French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 NL Addendum ICF Dutch_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1 M25-713 NL Main ICF Dutch _Public | 1.2 |
| Subject information and informed consent form (for publication) | L1 M25-713 NL Preg Part ICF Dutch_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1 M25-713 PL ICF Addendum for Treatment following Radiologic DP_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M25-713 PL ICF Main_Public | 3 |
| Subject information and informed consent form (for publication) | L1 M25-713 PL ICF Optional_Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-713 PL ICF Pregnancy_Public | 2 |
| Subject information and informed consent form (for publication) | L1 M25-713 PT ICF Addendum Continued Treatment_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 PT ICF Addendum Imagiologic Disease Progression_Public Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 PT ICF Main and Optional_Public Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1 M25-713 PT ICF Pregnant Data Release_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M25-713 AT ICF Addendum_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M25-713 AT ICF Main_public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M25-713 AT ICF pregnancy_public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M25-713 IT_ICF Addend for Treatment following Radiologic Disease Progression_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M25-713 IT_ICF Combined_Clean Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M25-713 IT_Pregnant Aut For Data Release Form_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M25-713_DE_ICF Addendum German_public | 1 |
| Subject information and informed consent form (for publication) | L1_M25-713_DE_ICF Main German_public | 1.3 |
| Subject information and informed consent form (for publication) | L1_M25-713_DE_ICF Main_track changes_MS | 1.2-1.3 |
| Subject information and informed consent form (for publication) | L1_M25-713_DE_ICF Pregnancy German_public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M25-713_DE_ICF Pregnancy track changes_MS | 1.1-1.2 |
| Subject information and informed consent form (for publication) | L1_M25-713_ES_ICF Add Radiologic Progression_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M25-713_ES_ICF Main Phase 2_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_M25-713_ES_ICF Optional Phase 2_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M25-713_ES_ICF Pregnant Partner_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_EU CTR blank document | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-amivantamab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-osimertinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_spc-pemetrexed | 1 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_DE-BE- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_FR-BE- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_FR-FR- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_IT-IT- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_NL-BE- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_NL-NL- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_PL-PL- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis_PT-PT- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis-EN-EN- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-euctr-synopsis-ES-ES- public | 1.0 |
| Synopsis of the protocol (for publication) | D1_m25713-scientific-synopsis_DE-AT | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-30 | Spain | Acceptable 2026-02-09
|
2026-02-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-17 | Spain | Acceptable 2026-02-09
|
2026-02-17 |