A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants with Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (FRAmework-01)

2025-522255-25-00 Protocol J5E-MC-JZXB Therapeutic confirmatory (Phase III) Authorised, recruiting

Start 18 May 2026 · Status Authorised, recruiting · 15 EU/EEA countries · 77 sites · Protocol J5E-MC-JZXB

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruiting
Participants planned 1,125
Countries 15
Sites 77

Fallopian Tube Neoplasms

(Part A) Platinum-Resistant Ovarian Cancer: To compare the efficacy of Sofetabart Mipitecan versus the control arm (investigator’s choice of chemotherapy or Mirvetuxima Soravtansine (MIRV)) (Part B) Platinum-Sensitive Ovarian Cancer: To compare the efficacy of Sofetabart Mipitecan plus bevacizumab versus the control ar…

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
18 May 2026 → ongoing
Decision date (initial)
2026-05-17
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2025-522255-25-00
ClinicalTrials.gov
NCT07213804

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

(Part A) Platinum-Resistant Ovarian Cancer: To compare the efficacy of Sofetabart Mipitecan versus the control arm (investigator’s choice of chemotherapy or Mirvetuxima Soravtansine (MIRV))
(Part B) Platinum-Sensitive Ovarian Cancer: To compare the efficacy of Sofetabart Mipitecan plus bevacizumab versus the control arm (investigator’s choice of platinum-based doublet chemotherapy plus bevacizumab)

Conditions and MedDRA coding

Fallopian Tube Neoplasms

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Have ovarian, peritoneal, or fallopian tube cancer.
  2. Have adequate organ function and blood counts, as measured by blood tests
  3. Be well enough to walk and do light work
  4. (Part A): Have had their cancer return or worsen 6 months or less after their last platinum chemotherapy.
  5. (Part B): Have had their cancer return or worsen 6 months or more after the last platinum chemotherapy.

Exclusion criteria 3

  1. Have taken a special kind of medicine called an "antibody-drug conjugate" that has a topoisomerase inhibitor (DNA untangler) in it.
  2. (Part A): Have had their cancer return or worsen within the first 3 months after the last dose of the first treatment with platinum chemotherapy.
  3. (Part B): Have too much protein in the urine (called "proteinuria").

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. • Part A: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator • Part B: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded, independent, central review (BICR)

Investigational products

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

Test 8

Topotecan

SCP134598913 · ATC

Active substance
Topotecan
Substance synonyms
Nogitecan
Route of administration
INTRAVENUS USE
Max daily dose
4 mg/m2 milligram(s)/sq. meter
Max total dose
470 mg/m2 milligram(s)/sq. meter
Max treatment duration
36 Month(s)
Authorisation status
Authorised
ATC code
L01CE01 — TOPOTECAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bevacizumab

SCP133733548 · ATC

Active substance
Bevacizumab
Substance synonyms
BI 695502, BS-503A, PF-06439535, BP01, HLX04, RHUMAB-VEGF, BEVACIZUMABUM, RHUMAB VEGF
Route of administration
INTRAVENOUS USE
Max daily dose
15 mg/kg milligram(s)/kilogram
Max total dose
783 mg/kg milligram(s)/kilogram
Max treatment duration
36 Month(s)
Authorisation status
Authorised
ATC code
L01FG01 — BEVACIZUMAB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mirvetuximab Soravtansine

SCP122657625 · ATC

Active substance
Mirvetuximab Soravtansine
Substance synonyms
IMGN853, Humanised anti-folate receptor 1 monoclonal antibody conjugated to maytansinoid DM4
Route of administration
INTRAVENUS USE
Max daily dose
6 mg/kg milligram(s)/kilogram
Max total dose
313 mg/kg milligram(s)/kilogram
Max treatment duration
36 Month(s)
Authorisation status
Authorised
ATC code
L01FX26 — MIRVETUXIMAB SORAVTANSINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SCP10337134 · ATC

Active substance
Carboplatin
Route of administration
INTRAVENUS USE
Max daily dose
900 mg/m2 milligram(s)/sq. meter
Max total dose
9000 mg/m2 milligram(s)/sq. meter
Max treatment duration
30 Week(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SCP119562649 · ATC

Active substance
Doxorubicin Hydrochloride
Route of administration
INTRAVENUS USE
Max daily dose
40 mg/m2 milligram(s)/sq. meter
Max total dose
1564 mg/m2 milligram(s)/sq. meter
Max treatment duration
36 Month(s)
Authorisation status
Authorised
ATC code
L01DB01 — DOXORUBICIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LY4170156

PRD11216527 · Product

Active substance
LY4170156
Pharmaceutical form
LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
Route of administration
INTRAVENUS USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Paclitaxel

SCP129816 · ATC

Active substance
Paclitaxel
Substance synonyms
ONCOGEL, ABI-007, MBT 0206
Route of administration
INTRAVENUS USE
Max daily dose
175 mg/m2 milligram(s)/sq. meter
Max total dose
12480 mg/m2 milligram(s)/sq. meter
Max treatment duration
36 Month(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine Hydrochloride

SCP1128788 · ATC

Active substance
Gemcitabine Hydrochloride
Substance synonyms
4-AMINO-1-[(2R,4R,5R)-3,3-DIFLUORO-4-HYDROXY-5-(HYDROXYMETHYL)OXOLAN-2-YL]PYRIMIDIN-2-ONE HYDROCHLORIDE
Route of administration
INTRAVENUS USE
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
104286 mg/m2 milligram(s)/sq. meter
Max treatment duration
36 Month(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 10

OrganisationCity, countryDuties
Icon Clinical Research LLC
ORG-100039864
 Rochester, United States Other
Pharmaserve Lilly S.A.C.I.
ORG-100005347
 Kifisia, Greece On site monitoring, Code 12, Other, Code 2, Code 5
IQVIA Limited
ORG-100008655
 Reading, United Kingdom Other
PPD Global Central Labs
ORG-100046496
 Zaventem, Belgium Other
Kcas LLC
ORG-100043073
 Olathe, United States Other
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Other
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States Other
Pharmaceutical Product Development LLC
ORG-100016999
 Highland Heights, United States Other
Medable Inc.
ORG-100043083
 Palo Alto, United States Other

Locations

15 EU/EEA countries · 77 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Authorised, recruitment pending 25 3
Belgium Authorised, recruitment pending 28 5
Czechia Authorised, recruitment pending 49 5
Denmark Authorised, recruitment pending 21 2
France Authorised, recruitment pending 77 11
Germany Authorised, recruitment pending 39 9
Greece Authorised, recruitment pending 20 4
Hungary Authorised, recruitment pending 7 2
Ireland Authorised, recruitment pending 13 3
Italy Authorised, recruitment pending 49 12
Netherlands Authorised, recruitment pending 21 2
Norway Authorised, recruitment pending 7 2
Poland Authorised, recruitment pending 56 5
Romania Ongoing, recruiting 18 4
Spain Ongoing, recruiting 56 8
Rest of world
Brazil, Canada, Japan, Mexico, Australia, United States, China, Switzerland, United Kingdom, Taiwan, Korea, Republic of
 — 639 —

Investigational sites

Austria

3 sites · Authorised, recruitment pending
Medizinische Universitaet Innsbruck
Univ.-Klinik f. Gynäkologie und Geburtshilfe, Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
Abteilung für Gynäkologie / Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University Of Vienna
Universitätsklinik für Frauenheilkunde, Waehringer Guertel 18-20, Alsergrund, Vienna

Belgium

5 sites · Authorised, recruitment pending
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
AZ ST-JAN Brugge A.V.
Oncology and /or Hematology, Ruddershove 10, 8000, Brugge
Az Maria Middelares Gent
IKG, Buitenring-Sint-Denijs 30, 9000, Gent
UZ Leuven
Gynecologic Oncology, Herestraat 49, 3000, Leuven
Institut Jules Bordet
Clinical Trial Conduct Unit (Completed) / Medicine Oncology (Incomplete), Mijlenmeersstraat 90, 1070, Anderlecht

Czechia

5 sites · Authorised, recruitment pending
Krajska Nemocnice T Bati a.s.
Onkologické oddělení, Havlickovo Nabrezi 600, 760 01, Zlin
Všeobecná fakultní nemocnice v Praze
Gynekologicko porodnická klinika, Apolinářská 18/441, 128 08, Praha 2
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
Gynekologicko-porodnická klinika, Obilni Trh 526/11, Veveri, Brno-Stred
Nemocnice AGEL Novy Jicin a.s.
Oddělení radioterapie a onkologie, Purkynova 2138/16, 741 01, Novy Jicin

Denmark

2 sites · Authorised, recruitment pending
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Lillebaelt Hospital
Oncology, Beriderbakken 4, 7100, Vejle

France

11 sites · Authorised, recruitment pending
Institut de Cancérologie de l'Ouest
Oncology, 15, Rue André Bocquel, Angers
Centre Hospitalier de la Côte Basque
Oncology, 13 Avenue de l'Interne Jacques Loëb, Bayonne, Bayonne
Centre Oscar Lambret
Oncology, 3 Rue Frédéric Combemale, Lille, Lille
CHRU de Brest
Institut de cancérologie et d'Hématologie, Bd Tanguy Prigent, Hôpital de la Cavale Blanche, Brest
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Oncology, 229 Cours de l'Argonne, Bordeaux, Bordeaux
Centre Hospitalier Et Universitaire De Limoges
Oncologie, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Les Hopitaux Universitaires De Strasbourg
Oncology and Hematology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Léon Bérard
Oncology, 28, Rue Laennec, Lyon
Hôpitaux Universitaires Paris Centre-Hôpital Cochin
Service d'Oncologie Medicale, 123 Bd de Port Royal, Batiment Copernic 5eme etage Service Oncologie, Paris
Institut Regional Du Cancer De Montpellier
Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Groupe Hospitalier Diaconesses Croix Saint Simon
URCEC, 125 Rue D Avron, 75020, Paris

Germany

9 sites · Authorised, recruitment pending
Universitaetsklinikum Erlangen AöR
Klinik für Gynäkologie und Geburtshilfe, Maximiliansplatz 2, Innenstadt, Erlangen
Universitaetsklinikum Bonn AöR
Gynaecological oncology, Venusberg-Campus 1, Venusberg, Bonn
Charité Campus Virchow-Klinikum
Charité Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin
Universitaetsklinikum Koeln AöR
Klinik und Poliklinik für Frauenheilkunde und Gynäkologische Onkologie, Kerpener Strasse 62, Lindenthal, Cologne
Technische Universitaet Dresden
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Fetscherstrasse 74, Johannstadt-Nord, Dresden
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Gynäkologie und Gynäkologische Onkologie, Henricistrasse 92, Huttrop, Essen
Universitaetsklinikum Duesseldorf AöR
Klinik für Frauenheilkunde & Geburtshilfe, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Aachen AöR
Frauenklinik, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Klinik für Gynäkologie und Geburtshilfe, Studienzentrale, Arnold-Heller-Strasse 3, 24105, Kiel

Greece

4 sites · Authorised, recruitment pending
Areteio Hospital
Oncology Unit, 2nd Surgical Department, Vassilissas Sofias Avenue 76, 115 28, Athens
General Hospital Of Messinia
Oncology Department, Antikalamos, 241 00, Kalamata
General Hospital Of Athens Alexandra
Oncology Department, University Clinic of Therapeutics, Vassilissis Sofias Avenue 80, 115 28, Athens
General Oncological Hospital Of Kifissia Agioi Anargyroi
Department of Medical Oncology, Timiou Stavrou And 14 Noufaron, 145 64, Kifissia

Hungary

2 sites · Authorised, recruitment pending
University Of Debrecen
Szuleszeti es Nogyogyaszati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Orszagos Onkologiai Intezet
Nogyogyaszat, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII

Ireland

3 sites · Authorised, recruitment pending
Cork University Hospital
Medical Oncology, Wilton, T12 DC4A, Cork
St James's Hospital
Haematology Oncology Palliative Care (HOPe), James's Street, D08 NHY1, Dublin 8
St Vincent's University Hospital
Medical Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4

Italy

12 sites · Authorised, recruitment pending
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Oncology, Via Guglielmo Lippi Francesconi 556, 55100, Lucca
Azienda Ospedaliero Universitaria Di Modena
DH Oncologia, Largo Del Pozzo 71, 41124, Modena
Ospedale Vito Fazzi Lecce
Medical Oncology University, Piazza Filippo Muratore 1, 73100, Lecce
Istituto Europeo Di Oncologia S.r.l.
Divisione Ginecologia Oncologica, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda USL Toscana Centro
SOC Oncologia Medica, Via Suor Niccolina Infermiera 20/22, 59100, Prato
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
SSD Oncologia Medica Zamagni, Via Pietro Albertoni 15, 40138, Bologna
Azienda Unita Sanitaria Locale Della Romagna
Oncologia medica, Viale Vincenzo Randi 5, 48121, Ravenna
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Oncologia Sperimentale Uro-Genitale, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Ginecologia Oncologica, Largo Agostino Gemelli 8, 00168, Rome
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia medica, Via Giacomo Venezian 1, 20133, Milan
Humanitas Mirasole S.p.A.
U.O. Ginecologia Oncologica Medica, Via Francesco Nava 31, 20159, Milan
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Oncologia medica, Via Messina 829, 95126, Catania

Netherlands

2 sites · Authorised, recruitment pending
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam

Norway

2 sites · Authorised, recruitment pending
Helse Stavanger HF
Gynecology and Obstetrics, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Oslo Universitetssykehus HF
Gynaecological Oncology, Montebello, Ullernchausséen 70, Oslo

Poland

5 sites · Authorised, recruitment pending
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Oddział Radioterapii i Onkologii Ginekologicznej, Ul. Garbary 15, 61-866, Poznan
Uniwersytecki Szpital Kliniczny W Bialymstoku
Uniwersyteckie Centrum Onkologii, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Mazowiecki Szpital Wojewodzki w Siedlcach Sp. z o.o.
Siedleckie Centrum Onkologii, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Uniwersyteckie Centrum Kliniczne
Kinika Ginekologii Onkologicznej I Endokrynologii Ginekologicznej, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Poradnia Onkologiczna oraz Oddział Kliniczny Onkologii, Ul. Mikolaja Kopernika 50, 31-501, Cracow

Romania

4 sites · Ongoing, recruiting
Institutul Regional De Oncologie Iasi
Medical Oncology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Oncocenter Oncologie Clinica S.R.L.
Oncology, Strada Garii 1a, 300166, Timisoara
Mnt Healthcare Europe S.R.L.
Oncology, Bulevardul Ficusului 40, 013975, Bucharest
Memorial Healthcare International S.R.L.
Oncology, Soseaua Ionescu-Sisesti Gheorghe 1, 013821, Bucharest

Spain

8 sites · Ongoing, recruiting
Hospital HM Sanchinarro
Oncology, Calle de Oña 10,, 28050, Madrid
Consorcio Hospitalario Provincial De Castellon
Oncology, Avinguda Del Doctor Clara 19, 12006, Castello De La Plana
Hospital Universitario Virgen De Las Nieves
Oncology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Infanta Sofía
Oncology, Paseo De Europa 34, 28702, San Sebastian De Los Reyes
Hospital Universitario De Toledo
Oncology, Avenue Del Rio Guadiana Sn, 45007, Toledo

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Romania 2026-05-27 2026-05-28
Spain 2026-05-18 2026-05-20

Results and documents

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

Documents 217 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol addendum EU 2025-522255-25-00_Redacted 4.0
Protocol (for publication) D1_Protocol Addendum_2025-522255-25-00_GR_Redacted 4
Protocol (for publication) D1_Protocol_2025-522255-25-00_GR_Redacted c
Protocol (for publication) D1_Protocol_2025-522255-25-00_Redacted c
Protocol (for publication) D4_Patient Facing Docs_copyright statement_14Jan26_IE 1
Protocol (for publication) D4_Patient facing documents_copyright statement 1
Protocol (for publication) D4_Study Participant Contact Card_GR 2
Recruitment arrangements (for publication) K1_ Recruitment and Informed consent procedure_IE_NREC_V2_14Jan26 2.0
Recruitment arrangements (for publication) K1_Recruitment allocation 1.0
Recruitment arrangements (for publication) K1_Recruitment and consenting procedure_Annex 3 1
Recruitment arrangements (for publication) K1_Recruitment and ICF Procedure 1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure 1
Recruitment arrangements (for publication) K1_Recruitment and Informed Consent Procedure 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements informent consent procedure_NO 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_IE_version 1_14Jan2026 NA
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Informed consent patient recruitment procedure 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_PL 3
Recruitment arrangements (for publication) K1_Recruitment procedure 3.0
Recruitment arrangements (for publication) K2_Recruitment material Brochure 2.1
Recruitment arrangements (for publication) K2_Recruitment material Flyer 2.0
Recruitment arrangements (for publication) K2_Recruitment material Poster 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure 2
Recruitment arrangements (for publication) K2_Recruitment material_Brochure 2.1
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_BEDU 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_FRA 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_IE_v2-1_08Jan2026_IE-EN 2.1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_Master 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Master_ES 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_NO 2.1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 2
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_BEDU 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_FRA 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_GR 2
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_IE_v2-1_08Jan2026_IE-EN 2.1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_Master 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_Master_ES 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_Master_NO 2
Recruitment arrangements (for publication) K2_Recruitment material_HU_Brochure 2.0
Recruitment arrangements (for publication) K2_Recruitment material_HU_Doctor Referral Letter_Redacted 4.0
Recruitment arrangements (for publication) K2_Recruitment material_HU_Flyer 2.0
Recruitment arrangements (for publication) K2_Recruitment material_HU_Poster 2.0
Recruitment arrangements (for publication) K2_Recruitment material_J5E-MC-JZXB_Brochure_Master 2
Recruitment arrangements (for publication) K2_Recruitment material_J5E-MC-JZXB_Flyer_Master 2
Recruitment arrangements (for publication) K2_Recruitment material_J5E-MC-JZXB_Poster_Master 2
Recruitment arrangements (for publication) K2_Recruitment material_Letter-Doctor-Referral_Master_v4_07Jan2026_IE-EN 4
Recruitment arrangements (for publication) K2_Recruitment material_Poster 2
Recruitment arrangements (for publication) K2_Recruitment material_Poster 1
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_BEDU 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_FRA 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_GR 2
Recruitment arrangements (for publication) K2_Recruitment material_Poster_IE_v2-1_08Jan2026_IE-EN 2.1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_Master 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_Master_ES 1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_Master_NO 2
Recruitment arrangements (for publication) K3_List of planned sites 1
Recruitment arrangements (for publication) K3_Recruitment and informed consent procedure 1.0
Subject information and informed consent form (for publication) L1_ICF Main_Part A_GR_Redacted 1
Subject information and informed consent form (for publication) L1_ICF Main_Part B_GR_Redacted 1.1
Subject information and informed consent form (for publication) L1_ICF_Optional Biopsy_GR_Redacted 1
Subject information and informed consent form (for publication) L1_ICF_Pre Screening_Part A_GR_Redacted 1
Subject information and informed consent form (for publication) L1_ICF_Pre Screening_Part B_GR_Redacted 1
Subject information and informed consent form (for publication) L1_Main ICF_Part A_Redacted 1
Subject information and informed consent form (for publication) L1_Main ICF_Part B_Redacted 1
Subject information and informed consent form (for publication) L1_Part A and Part B_Post Progression Optional Tumor Biopsy Consent_Redacted 1
Subject information and informed consent form (for publication) L1_Pre-screening ICF_Part A_Redacted 1
Subject information and informed consent form (for publication) L1_Pre-screening ICF_Part B_Redacted 1
Subject information and informed consent form (for publication) L1_Recruitment and Informed consent procedure 1
Subject information and informed consent form (for publication) L1_SIS and ICF Main ICF Part A BEDU_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main ICF Part B BEDU_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main Part A ENG_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main Part A_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF Main Part B ENG_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main Part B_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Biopsy Addendum_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF Part A Pre-screening BEDU_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Part A Pre-screening BEFR_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Part A Prescreening Addendum_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF Part B Pre-screening BEDU_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Part B Pre-screening BEFR_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Part B Prescreening Addendum_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF Right Not to Know Addendum 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Optional Genetic Research_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Optional Tumoral Biopsy Part A and Part B_Redacted 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum_A 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum_B 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum_Biopsy_FRA_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum_Part A_Pre-screening_FRA_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum_Part B_Pre-screening_FRA_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_DPA 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main A_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main B_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF Part A_NL_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF Part A_Redacted 4.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF Part A_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF Part B_NL_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF Part B_Redacted 4.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF Part B_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part A_BEFR_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part A_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part B_BEFR_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part B_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Part A_NO_redacted V4.0NOR3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Part B_NO_redacted V4.0NOR3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Part A_FRA_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Part A_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Part B_FRA_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Part B_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activity ICF_NL_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activity ICF_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Additional Consent_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Biopsy ICF_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Biopsy_NO_redacted V2.0NOR3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Biopsy_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Pre-Screening Part A_Redacted 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Pre-Screening Part B_Redacted 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Prescreening Part A_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Prescreening Part B_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Screening_Part A_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Screening_Part B_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Tumor Biopsy_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A and Part B_Post-Progression Optional Tumor Biopsy Consent_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A main_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A pre-screening_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A_Main_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A_Prescreening_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B main_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B pre-screening_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B_Main_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B_Prescreening_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Main ICF Part A_Redacted 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Main ICF_Part B_Redacted 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Optional Biopsy ICF_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Post-Progression Optional Tumor Biopsy Consent_ BEDU_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Post-Progression Optional Tumor Biopsy Consent_ BEFR_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening ICF Part A_NL_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening ICF Part A_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening ICF Part B_NL_Redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening ICF Part B_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_prescreening ICF_Part A_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_prescreening ICF_Part B_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening Part A_NO_redacted V3.0NOR2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening Part B_NO_redacted V2.0NOR2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening_A_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening_B_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Summary PIL_Part A 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Summary PIL_Part B 1.1
Subject information and informed consent form (for publication) L2_CT_Postcard_TY-Video-Retention_IE_v1-1_08Jan2026_IE-EN 1.1
Subject information and informed consent form (for publication) L2_CT_Video-Storyboard-Thank-You-Retention_IE_v1-1_08Jan2026_IE-EN 1.1
Subject information and informed consent form (for publication) L2_IE_J5E-MC-JZXB_Study Participant Emergency Contact Card_V2_14Jan26 2.0
Subject information and informed consent form (for publication) L2_JZXB_Part-A_Study-Guide_Master_v4_07Jan2026_IE-EN_redacted 4
Subject information and informed consent form (for publication) L2_JZXB_Part-B_Study-Guide_Master_v4_07Jan2026_IE-EN_redacted 4
Subject information and informed consent form (for publication) L2_JZXB_Study-Connect-Participant_Master_v4_08Jan2026_IE-EN 4
Subject information and informed consent form (for publication) L2_JZXB_Thank-You-End_Of_Participation_IE_v2-1_08Jan2026_IE-EN 2.1
Subject information and informed consent form (for publication) L2_JZXB_Visit-Card_IE_v2-1_08Jan2026_IE-EN 2.1
Subject information and informed consent form (for publication) L2_List of ssICF contact details_Redacted 1
Subject information and informed consent form (for publication) L2_Other subject information material_Brochure 2
Subject information and informed consent form (for publication) L2_Other subject information material_Confidentiality Notice_NL 2.0
Subject information and informed consent form (for publication) L2_Other subject information material_Part-A_Study-Guide_Redacted 4.1
Subject information and informed consent form (for publication) L2_Other subject information material_Part-B_Study-Guide_Redacted 4.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient card 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Information Card 2
Subject information and informed consent form (for publication) L2_Other subject information material_Poster 2
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Thank You End Of Participation_GR 2
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Visit Card_GR 2
Subject information and informed consent form (for publication) L2_Other subject information material_Visit-Card 2
Subject information and informed consent form (for publication) L2_Other Subject Information_Part A_Study Guide_GR_Redacted 4
Subject information and informed consent form (for publication) L2_Other Subject Information_Part B_Study Guide_GR_Redacted 4
Subject information and informed consent form (for publication) L2_Other Subject Information_Patient card 1.0
Subject information and informed consent form (for publication) L2_Patient Card text_Redacted 1.0
Subject information and informed consent form (for publication) L2_Recruitment and Informed consent procedure PL 4
Subject information and informed consent form (for publication) L2_Study Participant Contact Card 1
Subject information and informed consent form (for publication) L2_Study Participant Contact Card_GR 2
Subject information and informed consent form (for publication) L3_Other subject information material_Study Participant Contact Card 1
Subject information and informed consent form (for publication) L3_Patient card_Austria 1
Summary of Product Characteristics (SmPC) (for publication) E2_Bevacizumab SmPC N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Bevacizumab N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Carboplatin N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Gemcitabine NA
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Gemzar N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_mirvetuximab soravtansine N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Paclitaxel N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Pegylated Liposomal doxorubicin N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Topotecan N/A
Synopsis of the protocol (for publication) D1_Protocol Synopsis 2025-522255-25-00 PL_Redacted c
Synopsis of the protocol (for publication) D1_Protocol synopsis EN 2025-522255-25-00_Redacted c
Synopsis of the protocol (for publication) D1_Protocol synopsis IT 2025-522255-25-00_Redacted c
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2025-522255-25-00_GR_Redacted c
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEDE_2025-522255-25-00_Redacted 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEDU_2025-522255-25-00_Redacted 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEFR_2025-522255-25-00_Redacted 4
Synopsis of the protocol (for publication) D1_Protocol Synopsis_c_IE_2025-522255-25-00_LY4170156_redacted c
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2025-522255-25-00_Redacted c
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2025-522255-25-00_Redacted c
Synopsis of the protocol (for publication) D1_Protocol Synopsis_FRA_2025-522255-25-00_Redacted Amdt C
Synopsis of the protocol (for publication) D1_Protocol synopsis_HU 2025-522255-25-00_Redacted c
Synopsis of the protocol (for publication) D1_Protocol synopsis_J5E-MC-JZXB_NO_2025-522255-25-00_NO_Redacted c
Synopsis of the protocol (for publication) D1_Protocol Synopsis_JZXB_AT_2025-522255-25-00_Redacted c
Synopsis of the protocol (for publication) D1_Protocol Synopsis_NL 2025-522255-25-00_Redacted 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_RO_2025-522255-25-00_Redacted c

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-01-21 Germany Acceptable
2026-05-11
 2026-05-11

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