Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
130
Countries
7
Sites
39
Advanced or Metastatic Non-small Cell Lung Cancer
To evaluate objective response (OR) by dose level.
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
- 12 Sep 2025 → ongoing
- Decision date (initial)
- 2025-08-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519814-29-00
- WHO UTN
- U1111-1315-9473
- ClinicalTrials.gov
- NCT06855771
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Dose response, Pharmacodynamic, Safety
To evaluate objective response (OR) by dose level.
Secondary objectives 5
- To evaluate disease control (DC), duration of response (DOR), progression free survival (PFS), and time to objective response (TTOR) by dose level
- To evaluate safety and tolerability by dose level.
- To evaluate DC, PFS, TTOR, and DOR.
- To evaluate overall survival.
- To evaluate the impact of disease symptoms and treatment on a participant’s health-related quality-of-life.
Conditions and MedDRA coding
Advanced or Metastatic Non-small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue.
- Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
- At least 1 measurable lesion as per RECIST v1.1.
- Documented radiographic disease progression on or after the most recent line of treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF
- Capability to swallow.
Exclusion criteria 4
- Active brain metastases or carcinomatous meningitis.
- Prior treatment with a PRMT5 or MAT2A inhibitor.
- Known severe hypersensitivity to study treatment and/or any of its excipients.
- Other protocol-defined inclusion/exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary endpoints 11
- Number of participants who achieve disease control (DC) as assessed by RECIST v1.1
- Duration of response (DOR) as assessed by RECIST v1.1
- Progression-free survival (PFS) as assessed by RECIST v1.1
- Time to objective response (TTOR) as assessed by RECIST v1.1
- Number of participants with adverse events (AE)
- Number of participants with Serious AEs (SAEs)
- Number of participants with AEs leading to dose interruption, reduction, or discontinuation
- Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1
- Overall Survival
- Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score
- Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
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
- 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Massive Bio Inc. ORG-100044618
|
New York, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Discovery Life Sciences Biomarker Services GmbH ORG-100042520
|
Kassel, Germany | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| CellCarta Biosciences ORG-100039314
|
Charleroi, Belgium | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | Other |
| Somalogic Operating Co. Inc. ORG-100042788
|
Boulder, United States | Other |
Locations
7 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 14 | 8 |
| Germany | Ongoing, recruiting | 10 | 5 |
| Italy | Ongoing, recruiting | 13 | 7 |
| Poland | Authorised, recruiting | 4 | 2 |
| Romania | Ongoing, recruiting | 14 | 7 |
| Spain | Ongoing, recruiting | 15 | 8 |
| Sweden | Ongoing, recruiting | 4 | 2 |
| Rest of world
United States, United Kingdom, Australia, Japan, China
|
— | 56 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
Oncologie thoracique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Assistance Publique Hopitaux De Paris
Pneumologie, Oncologie thoracique, 4 Rue De La Chine, 75020, Paris
CHRU De Nancy
Pneumologie, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Assistance Publique Hopitaux De Paris
Pneumologie, Oncologie thoracique, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Institut Curie
Pneumologie, 26 Rue D Ulm, 75005, Paris
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Oncologie, 185 Rue Raymond Losserand, 75014, Paris
Centre Hospitalier Universitaire De Nantes
Oncologie médicale, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hospices Civils De Lyon
Pneumologie, 59 Boulevard Pinel, 69500, Bron
Klinikum der Universitaet Muenchen AöR
Medizinischen Klinik und Poliklinik V, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Klinik für Innere Medizin II - Pneumologie, Roentgenstrasse 1, Doelau, Halle (saale)
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum (ISZ) mit Ectu, Straubmuehlweg 2a, Grombuehl, Wuerzburg
University Hospital Cologne AöR
Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Thoracopulmonary, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncology and Hematology, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS San Gerardo Dei Tintori
Oncology, Via Giovanni Battista Pergolesi 33, 20900, Monza
ASST Grande Ospedale Metropolitano Niguarda
Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncology and Hematology, Via Sergio Pansini 5, 80131, Naples
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncology, Via Giacomo Venezian 1, 20133, Milan
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Poradnia oknologiczna, Ul. Koscielna 61, 05-135, Wieliszew
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Oddział Pulmonologii, Ul. Kuracyjna 30, 82-550, Prabuty
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
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Centrul De Diagnostic Si Tratament Provita S.A.
Oncology, Bulevardul Dimitrie Pompeiu Nr 9-9a Iride Business Park Sector 2, 11273, Bucharest
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Institutul Regional De Oncologie Iasi
Oncology, Strada Sararie 177b, 700451, Iasi
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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
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 |
|---|---|---|---|---|---|
| France | 2025-09-12 | 2025-09-16 | |||
| Germany | 2025-09-12 | 2025-11-06 | |||
| Italy | 2025-09-26 | 2026-02-13 | |||
| Poland | 2025-09-15 | ||||
| Romania | 2025-11-27 | 2025-12-09 | |||
| Spain | 2025-09-22 | 2025-10-24 | |||
| Sweden | 2025-10-09 | 2025-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 85 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519814-29-00 Redacted | 02 |
| Protocol (for publication) | D1_Protocol Admin Letter 2024-519814-29-00 Redacted | 02 |
| Protocol (for publication) | D1_Protocol Administrative Letter 03_2024-519814-29-00 Redacted | 03 |
| Protocol (for publication) | D4_Patient Facing Document_ questionnaire_blank statment_IT | 1 |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_EN | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_FR | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_DE | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_ES | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_SE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_TC | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC form_FR | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_For publication | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient Brochure_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material patient brochure_DE_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_IT | 1 |
| Subject information and informed consent form (for publication) | CA240-0009_List of changes_NMS3_IT | 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 Main_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Adult _IT_Redacted | 4 |
| 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_redacted | 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_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 _IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pre Screening Data Privacy_IT_Redacted | 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 Partner_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Prescreening_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_Data Privacy _IT_Redacted | 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 _IT_unredacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Clean_Redacted | 1 |
| 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_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant who Becomes Pregnant_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL_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 Treatment Beyond Progression_Clean_No redaction | 1 |
| 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) | L1_SIS and ICF_Main_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research_ES_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional samples collection__FDT_ES_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional samples collection_D1C2_ES_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Samples_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-Screening_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-Screening_PL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant participant_ES_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_FR | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_ES_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PreScreening_FR | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond Progression_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression_ES | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatmt Beyond Progression_FR | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519814-29 _IT | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2024-519814-29_SE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2024-519814-29_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2024-519814-29_ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2024-519814-29_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2024-519814-29_RO | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CTR 2024-519814-29_FR | 2.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-11 | Germany | Acceptable 2025-08-01
|
2025-08-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-12 | Acceptable 2025-08-01
|
2025-08-12 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-12 | Acceptable 2025-08-01
|
2025-08-12 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-08-14 | Acceptable 2025-08-01
|
2025-11-10 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-11 | Acceptable 2025-08-01
|
2025-11-11 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-14 | Germany | Acceptable 2025-08-01
|
2025-11-14 |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-24 | Germany | Acceptable 2026-01-21
|
2026-01-22 |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-23 | Germany | Acceptable 2026-05-08
|
2026-05-08 |