Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
580
Countries
15
Sites
85
metastatic non-small cell lung cancer
Phase 2: To evaluate progression free survival (PFS) of BMS-986504 plus pembrolizumab and chemotherapy vs. placebo plus pembrolizumab and chemotherapy. Phase 3, Dual Primary Objectives: 1) To compare PFS of BMS-986504 plus pembrolizumab and chemotherapy vs. placebo plus pembrolizumab and chemotherapy. 2)To compare over…
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]
- Trial duration
- 18 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521511-40-00
- WHO UTN
- U1111-1319-8383
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Safety, Therapy
Phase 2: To evaluate progression free survival (PFS) of BMS-986504 plus pembrolizumab and chemotherapy vs. placebo plus pembrolizumab and chemotherapy.
Phase 3, Dual Primary Objectives:
1) To compare PFS of BMS-986504 plus pembrolizumab and chemotherapy vs. placebo plus pembrolizumab and chemotherapy.
2)To compare overall survival (OS) of BMS-986504 plus pembrolizumab and chemotherapy vs. placebo plus pembrolizumab and chemotherapy
Secondary objectives 3
- Phase 2: To evaluate objective response (OR), disease control (DC), time to objective response (TTOR), and duration of response (DOR) of BMS-986504 plus pembrolizumab and chemotherapy vs. placebo plus pembrolizumab and chemotherapy
- Phase 3: To evaluate OR, DC, DOR, PFS, and PFS2 of BMS-986504 plus pembrolizumab and chemotherapy vs. placebo plus pembrolizumab and chemotherapy
- Phase 2 : To assess the safety and tolerability of BMS-986504 plus pembrolizumab plus chemotherapy vs placebo plus pembrolizumab plus chemotherapy
Conditions and MedDRA coding
metastatic non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 21.1 | PT | 10029515 | Non-small cell lung cancer recurrent | 100000004864 |
| 28.0 | LLT | 10025055 | Lung cancer non-small cell stage IV | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Participants must be aged ≥ 18 years (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
- Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
- Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase MTAP deletion or MTAP loss.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Participants must have at least 1 measurable lesion as per RECIST v1.1.
Exclusion criteria 4
- Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
- Participants must not have symptomatic brain metastases or spinal cord compression.
- Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
- Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Phase 2: Progression free survival (PFS) by RECIST v1.1
- Phase 3: Progression free survival (PFS) by RECIST v1.1
- Phase 3: overall survival (OS).
Secondary endpoints 3
- Phase 2: objective response (OR), disease control (DC), time to objective response (TTOR), and duration of response (DOR)by RECIST v1.1
- Phase 3: objective response (OR), disease control (DC), time to objective response (TTOR), duration of response (DOR), progression free survival (PFS) and PFS2 by RECIST v1.1
- Phase 2: Treatment-related and all-cause adverse events (AEs), serious AEs (including fatal AEs); AEs leading to dose interruption, dose reduction, and study treatment discontinuation and laboratory abnormalities
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
PRD12193680 · Product
- Active substance
- 2-4-4-AMINOMETHYL-1-OXO-2H-PHTHALAZIN-6-YL-2-METHYLPYRAZOL-3-YL-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- 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.
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.
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
- 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.
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 200 mg/m2 milligram(s)/sq. 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.
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 200 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.
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- POWDER FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 100 mg/m2 milligram(s)/sq. 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.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
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 Representative
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT Representative
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Code 12, Other |
| Discovery Life Sciences Biomarker Services GmbH ORG-100042520
|
Kassel, Germany | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
| Mural Health Technologies Inc. ORG-100051510
|
Berwyn, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Massive Bio Inc. ORG-100044618
|
New York, United States | Other |
Locations
15 EU/EEA countries · 85 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 6 | 3 |
| Belgium | Ongoing, recruiting | 10 | 5 |
| Bulgaria | Ongoing, recruiting | 12 | 6 |
| Czechia | Authorised, recruiting | 5 | 2 |
| Denmark | Authorised, recruitment pending | 3 | 1 |
| France | Ongoing, recruiting | 32 | 15 |
| Germany | Ongoing, recruiting | 30 | 9 |
| Greece | Authorised, recruitment pending | 10 | 6 |
| Hungary | Authorised, recruiting | 8 | 4 |
| Italy | Authorised, recruiting | 16 | 8 |
| Netherlands | Ongoing, recruiting | 4 | 1 |
| Poland | Authorised, recruiting | 12 | 6 |
| Romania | Ongoing, recruiting | 20 | 10 |
| Spain | Authorised, recruiting | 20 | 8 |
| Sweden | Authorised, recruiting | 3 | 1 |
| Rest of world
Malaysia, Turkey, Switzerland, South Africa, United States, India, Mexico, Hong Kong, Australia, Japan, United Kingdom, Thailand, Chile, Israel, Korea, Republic of, Canada, Taiwan, Colombia, Argentina, China, Brazil
|
— | 389 | — |
Investigational sites
Ordensklinikum Linz GmbH
Department of Pneumology, Fadingerstrasse 1, 4020, Linz
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department of Oncology, Carinagasse 47, 6800, Feldkirch
Stadt Wien Wiener Gesundheitsverbund
Department of Internal Medicine and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
Jessa Ziekenhuis
Pneumology, Stadsomvaart 11, 3500, Hasselt
Centre hospitalier universitaire de Liege
Medical Oncology, Avenue De L'Hopital 1, 4000, Liege
Algemeen Ziekenhuis Delta
Pneumology, Deltalaan 1, 8800, Roeselare
UZ Brussel
Medical Oncology, Laarbeeklaan 101, 1090, Jette
University Hospital Antwerp
Pulmonary Medecine_Thoracic oncology, Drie Eikenstraat 655, 2650, Edegem
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department – Medical Oncology Level III, Georgi Benkovski Street 100, 4500, Panagyurishte
University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
Department – Medical Oncology Level III, Bulevard Pencho Slaveykov 52a, 1431, Sofia
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department – Medical Oncology Level II, Bulevard Siedinenie 49, 6304, Haskovo
Complex Oncology Center Ruse EOOD
Department – Medical Oncology Level II, 2 Nezavisimost street, 7000, Ruse
MBAL Trakia EOOD
Department – Medical Oncology Level III, Ulitsa Dunav 1, 6004, Stara Zagora
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department – Medical Oncology Level III, Oborishte Distr., Ul.Byalo More 8, Sofia
Fakultni Nemocnice Hradec Kralove
Plicni klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
University Hospital Olomouc
Klinika plicnich nemoci a tuberkulozy, Zdravotniku 248/7, 779 00, Olomouc
Copenhagen University Hospital
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Universitaire De Bordeaux
Pneumonology, Avenue Du Haut Leveque, 33600, Pessac
Centre Hospitalier Regional Et Universitaire De Brest
Pneumonology, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2
Institut Curie
Pneumonology, 26 Rue D Ulm, 75005, Paris
Institut Regional Du Cancer De Montpellier
Pneumonology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Centre Hospitalier Regional Universitaire
Pneumonology, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Centre Hospitalier Universitaire De Rennes
Pneumonology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Dijon
Pneumonology, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Hospices Civils De Lyon
Pneumonology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Paoli Calmettes
Pneumonology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Toulouse
Pneumonology, 24 Chemin De Pouvourville, 31400, Toulouse
CHRU De Nancy
Pneumonology, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
CHU Gabriel-Montpied
Pneumonology, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Francois Baclesse
Pneumonology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Regional Universitaire De Tours
Pneumonology, 2 Boulevard Tonnelle, 37000, Tours
Groupe Hospitalier Paris Saint Joseph
Pneumonology, 185 Rue Raymond Losserand, 75014, Paris
Bundeswehrkrankenhaus Ulm
Schwerpunkt Hämatologie und Onkologie, Oberer Eselsberg 40, Eselsberg, Ulm
Alb Fils Kliniken GmbH
Zentrum für Hämatologische Neoplasien, Eichertstrasse 3, Stadtgebiet, Goeppingen
SLK-Kliniken Heilbronn GmbH
Medizinische Klinik II Onkologie / Krebsheilkunde mit Palliativmedizin, Geisshoelzle 62, Hirrweiler, Loewenstein
Pius-Hospital Oldenburg
Klinik für Hämatologie und Onkologie, Georgstrasse 12, Innenstadt, Oldenburg
Lungenfachklinik Immenhausen
Thoraxonkologie, Robert Koch Strasse 3, 34376, Immenhausen
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik fuer Innere Medizin III - Hämatologie und Onkologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Abteilung für Pneumologische Onkologie, Auerbachstrasse 112, Bad Cannstatt, Stuttgart
LungenClinic Grosshansdorf GmbH
Onkologie, Woehrendamm 80, 22927, Grosshansdorf
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Klinik für Onkologie und Hämatologie, Pruefeninger Strasse 86, Westenviertel, Regensburg
Theageneio Cancer Hospital
3rd Department of Oncology Clinic, Simeonidi Alex 2, 546 39, Thessaloniki
Henry Dunant Hospital Center
4th Department of Oncology & Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
General University Hospital Of Patras
Division of Oncology, Department of Medicine, Rio, 265 04, Patras
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine, Oncology Unit & Laboratory, Messogion Avenue 152, 115 27, Athens
Alexandra Hospital
Oncology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
General University Hospital Of Larissa
Oncology Clinic, Chemotherapy Department, P. O. Box 1425, 411 10, Larissa
Matrai Gyogyintezet
Bronchologiai osztaly, Matrahaza Hrsz 7151, 3200, Gyongyos
Bekes Varmegyei Koezponti Korhaz
Tudogyogyaszat es legzesrehabilitacios osztaly, Sitka Tanya 1, 5700, Gyula
Clinic Of Pulmonology Semmelweis University
Pulmonológiai Klinika, Tomo Utca 25-29, 1083, Budapest Viii
Farkasgyepui Tudogyogyintezet
I. pulmonologia, 049 Hrsz 2, 8582, Farkasgyepu
Ospedale Santa Maria delle Croci
Oncology, V. Le Randi 5, 48121, Ravenna
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncology-Hematology, Via Pietro Albertoni 15, 40138, Bologna
IRCCS - Ospedale San Raffaele
Medical Oncology, Via Olgettina 60, 20132, Milano
Ospedale Santa Maria Della Misericordia - Azienda Ospedaliera di Perugia
Medical Oncology, via Dottori 1, 06132, Perugia
Centro Di Riferimento Oncologico Di Aviano
Clinical Oncology, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncologia Polmonare, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Oncoematologia, Via Sergio Pansini 5, 80131, Naples
Universitair Medisch Centrum Groningen
Pulmonology, Hanzeplein 1, 9713 GZ, Groningen
Pratia S.A.
NA, Ul. Gryfinska 1, 60-192, Poznan
Lux Med Onkologia Sp. z o.o.
Oddział Onkologii Klinicznej/Chemioterapii, Ul. Gen. Augusta Emila Fieldorfa Nila 40, 04-125, Warsaw
Pratia S.A.
NA, Ul. Pana Tadeusza 2, 30-727, Cracow
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Oddział Pulmonologii, Ul. Kuracyjna 30, 82-550, Prabuty
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Poradnia Onkologiczna, Ul. Koscielna 61, 05-135, Wieliszew
Centrul De Diagnostic Si Tratament Provita S.A.
Oncology, Bulevardul Dimitrie Pompeiu Nr 9-9a Iride Business Park Sector 2, 11273, Bucharest
Spitalul Municipal Ploiesti
Oncology, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Institutul Regional De Oncologie Iasi
Oncology, Strada Sarariei, nr 177B, Iasi
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Radiology Therapeutic Center S.R.L.
Oncology, Strada Drumul Odai Nr 42, 075100, Otopeni
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
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 Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
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 Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 | 2025-11-18 | 2025-12-16 | |||
| Belgium | 2025-12-10 | 2026-01-06 | |||
| Bulgaria | 2026-01-22 | 2026-02-19 | |||
| Czechia | 2026-02-09 | ||||
| France | 2025-11-19 | 2025-12-18 | |||
| Germany | 2025-11-21 | 2025-12-17 | |||
| Hungary | 2026-03-17 | ||||
| Italy | 2025-12-17 | ||||
| Netherlands | 2025-12-01 | 2025-12-01 | |||
| Poland | 2025-12-10 | ||||
| Romania | 2025-11-27 | 2025-12-02 | |||
| Spain | 2025-11-24 | ||||
| Sweden | 2025-11-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 183 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521511-40-00_GR_Redacted | 01 EU |
| Protocol (for publication) | D1_Protocol_2025-521511-40-00_redacted | 02 EU |
| Recruitment arrangements (for publication) | K_Recruitment arrangements DK | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_CA240-0029_BG_Recruitment arrangements_BG | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arragements_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement Form_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Invite to Trial Letter_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invite to Trial Letter_BG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Invite to Trial Letter_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Invite to Trial Letter_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Invite to Trial Letter_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Recruitment Brochure_BG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Recruitment Poster_BG | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 2.0 |
| 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_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Participant who Becomes Pregnant_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pre Screening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression_IT | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Future Research_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Main_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Optional Sample Collection_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Pre Screening_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Pregnant Participant_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Pregnant Partner_clean | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Treatment Beyond Progression | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Future Research_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Main_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Optional Sample Collection_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Pre Screening_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Pregnant Participant_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Pregnant Partner_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS and ICF Treatment Beyond Progression | 1 |
| Subject information and informed consent form (for publication) | L1_DK Add IC Right not to know_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Future Research_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Sample Collection_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Pre-screening_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Treatmeant Beyond Progression_Clean_No redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Prescreening_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_BG_v1_0_7Jul2025_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_EN_v1_0_7Jul2025_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_ES_Redacted | 3 |
| 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_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_Dutch_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_Eng_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted_French_BE | 1.1 |
| 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 Future Research_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_IT_Redacted | 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 Research for Bulgaria_BG_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Research for Bulgaria_EN_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Research v1_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection for Bulgaria_BG_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection for Bulgaria_EN_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection ICF v1_Part 1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection ICF v1_Part 2_Redacted | 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 Optional Sample Collection_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_NL_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples_Redacted_Dutch_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples_Redacted_Eng_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples_Redacted_French_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant who Becomes Pregnant ICF v1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant who Becomes Pregnant_BG_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant who Becomes Pregnant_EN_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening ICF_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_BG_v1_0_7Jul2025_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_EN_v1_0_7Jul2025_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_Redacted_Dutch_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_Redacted_Eng_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_Redacted_French_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner for Bulgaria_BG_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner for Bulgaria_EN_v1_0_7Jul2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ICF v1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_Redacted_Dutch_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_Redacted_Eng_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_Redacted_French_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening IC_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PreScreening_Redacted_Dutch_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PreScreening_Redacted_Eng_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PreScreening_Redacted_French_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy notice_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression for Bulgaria_BG_v1_0_7Jul2025 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression for Bulgaria_EN_v1_0_7Jul2025 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression ICF v1_ES_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_Dutch_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_En_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_French_BE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_GR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_no redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_sponsor statement model BMS | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_CZ_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participant who Becomes Pregnant_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pharmacogenetic ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pharmacogenetic PIS_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-Screening_CZ_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_CZ | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2 Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Persona Data_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_other Subject Information Site Details for all ICFs_AT_V03_clean | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nab-paclitaxel Abraxane BMS_Tracked changes | 32 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40_Dutch_BE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40_FR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40_French_BE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40_German_BE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521511-40_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40-00 _ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521511-40-00_BG | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-521511-40-00_CZ | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40-00_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40-00_GR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-521511-40-00_HU | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_Ger2025-521511-40-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2025-521511-40-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-521511-40_SE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2025-521511-40-00_RO | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2025-521511-40-00 | 2 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-14 | Germany | Acceptable 2025-10-22
|
2025-10-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-11 | Acceptable 2025-10-22
|
2025-11-11 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-12 | Acceptable 2025-10-22
|
2025-11-12 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-12 | Acceptable 2025-10-22
|
2025-11-12 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-12 | Acceptable 2025-10-22
|
2025-11-12 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-11-12 | Acceptable 2025-10-22
|
2025-11-12 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-13 | Germany | Acceptable | 2025-11-14 |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-17 | Acceptable | 2025-12-16 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-27 | Germany | Acceptable | 2026-01-20 |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-27 | Acceptable | 2026-01-20 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-01-21 | Germany | Acceptable | 2026-01-21 |