A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors

A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, in Participants With MTAP-deleted Solid Tumors.

The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells.

The main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors.

For this, the researchers will study and analyze:

• the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity.
• the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose.
• the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses.
• the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses.

Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse.

The study participants will take part in one of the eight distinct groups or "intervention cohorts" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase.

Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems.

Participants will visit the study site:

• at least twice before the treatment starts
• multiple times when they start taking the treatment
• once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason

During the study, the doctors and their study team will:

• check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram
• check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan
• take tumor samples

The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.

Study Overview

• Status: Recruiting
• Conditions: MTAP-deleted Solid Tumors
• Intervention / Treatment: Drug: BAY 3713372

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse
    • Concord, New South Wales, Australia, 2139
      • Recruiting
      • Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre
    • Epping, New South Wales, Australia, 3076
      • Suspended
      • Northern Hospital
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Hospital Newcastle - Oncology
• Belgium
  • Antwerp, Belgium, 2650
    • Recruiting
    • Antwerp University Hospital | Oncology Department
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital | Drug Research Unit Department
  • Liège, Belgium, 4000
    • Recruiting
    • Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Medical Oncology
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Not yet recruiting
      • UZ Leuven Gasthuisberg - Pneumology Department
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital - Oncology Department
  • Hubei
    • Wuhan, Hubei, China, 430075
      • Not yet recruiting
      • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
• Czechia
  • Brno, Czechia, 602 00
    • Not yet recruiting
    • Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
  • Olomouc, Czechia, 779 00
    • Not yet recruiting
    • Fakultní nemocnice Olomouc - Onkologická klinika
• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Recruiting
      • Rigshospitalet - Kræftbehandling
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Recruiting
      • Odense University Hospital - Oncology Department
• Italy
  • Aviano, Italy, 33081
    • Not yet recruiting
    • Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
  • Milan, Italy, 20133
    • Not yet recruiting
    • Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
  • Roma, Italy, 00128
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
  • Roma, Italy, 00144
    • Not yet recruiting
    • I.F.O. Istituti Fisioterapici Ospitalieri - Sperimentazioni cliniche Fase 1 e Medicina di precisione
  • Rozzano, Italy, 20089
    • Recruiting
    • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Not yet recruiting
      • Nagoya University Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Not yet recruiting
      • National Cancer Center Hospital East
  • Osaka
    • Sakai, Osaka, Japan, 590-0197
      • Not yet recruiting
      • Kindai University Hospital
  • Shizuoka
    • Sunto, Shizuoka, Japan, 411-8777
      • Recruiting
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • Recruiting
      • The Cancer Institute Hospital of JFCR
• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Recruiting
      • Nederlands Kanker Instituut
  • Provincie Groningen
    • Groningen, Provincie Groningen, Netherlands, 9713 GZ
      • Not yet recruiting
      • Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 CE
      • Not yet recruiting
      • Erasmus Medisch Centrum
• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital Medical Centre
  • Singapore, Singapore, 168583
    • Recruiting
    • National Cancer Center Singapore - Oncology Department
  • Singapore, Singapore, 217562
    • Not yet recruiting
    • Icon Cancer Centre
• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08023
      • Recruiting
      • Hospital Hm Nou Delfos | Oncologia
    • Barcelona, Barcelona, Spain, 08035
      • Not yet recruiting
      • Hospital Universitari Vall D Hebron | Oncologia
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Not yet recruiting
      • Hospital San Pedro | Oncologia
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Hospital Universitario Fundacion Jimenez Diaz | Oncologia
    • Pamplona, Madrid, Spain, 31008
      • Not yet recruiting
      • Clinica Universidad De Navarra | Pamplona | Oncologia
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Recruiting
      • NEXT - Hospital Universitario Quironsalud Madrid | Oncologia
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Recruiting
      • Hospital Universitario Virgen De La Victoria | Oncologia
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Not yet recruiting
      • Hospital Clinico Universitario De Valencia | Oncologia
• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 171 76
      • Recruiting
      • Karolinska Universitetssjukhuset - Solna - Fas I-enheten Solna CKC
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 413 46
      • Not yet recruiting
      • Sahlgrenska Universitetssjukhuset - Sahlgrenska Sjukhuset - Klinisk prövningsenhet Fas I/FIH
• United Kingdom
  • Manchester, United Kingdom, M20 5BX
    • Recruiting
    • The Christie NHS Foundation Trust | Christie Hospital - Experimental Cancer Medicine Team
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Not yet recruiting
      • The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Not yet recruiting
      • UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
  • California
    • Duarte, California, United States, 91010
      • Not yet recruiting
      • City of Hope - Duarte Cancer Center
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • UCLA Health Bowyer Oncology Center
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • UCSF Helen Diller Medical Center at Parnassus Heights - Neurology
    • Stanford, California, United States, 94305
      • Not yet recruiting
      • Stanford University Medical Center - Neurology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Massachusetts General Hospital - Neurology
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Dana-Farber Cancer Institute - Oncology Department
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START | Midwest
  • New York
    • New York, New York, United States, 10029
      • Not yet recruiting
      • Icahn School of Medicine at Mount Sinai - Oncology
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Memorial Sloan Kettering Cancer Center New York - Main Campus
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners
  • Texas
    • Irving, Texas, United States, 75039
      • Recruiting
      • NEXT Dallas - Oncology Department
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • START | San Antonio
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Froedtert Hospital - Clinical Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be ≥ 18 years old of age, or the legal age of consent in the jurisdiction of the country in which the study takes place, at the time of signing the informed consent.
• At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
• Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

• Previous additional cancer other than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.
• A marked prolongation of QT/QTc interval at screening (e.g., repeated demonstration of a QTc interval >450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible based on the investigator's clinical assessment and discretion.

• Cardiac history comprising:

  • History of congestive heart failure Class >II according to the New York Heart Association Functional Classification.
  • Myocardial infarction less than 6 months before the start of study intervention.
  • Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers.
• Unstable angina within 4 weeks before start of study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation (Intervention Cohort 1); For the escalation part, different dose levels of BAY 3713372 administered as monotherapy are planned.	Drug: BAY 3713372; Daily oral administration
Experimental: Backfill cohorts in Intervention Cohort 1 (Dose Escalation); Backfill cohorts may be initiated concurrently with dose escalation cohorts to generate additional safety, pharmacokinetic, and pharmacodynamic data to facilitate the selection of the optimal doses for use in further development.	Drug: BAY 3713372; Daily oral administration
Experimental: Dose Expansion (Intervention Cohort 1); Dose expansion with BAY 3713372 monotherapy in selected participants with MTAP-deleted solid tumors.	Drug: BAY 3713372; Daily oral administration
Experimental: Dose Expansion (Intervention Cohort 2); Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted non-small cell lung cancer (NSCLC).	Drug: BAY 3713372; Daily oral administration
Experimental: Dose Expansion (Intervention Cohort 3); Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.	Drug: BAY 3713372; Daily oral administration
Experimental: Dose Expansion (Intervention Cohort 4); Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted NSCLC.	Drug: BAY 3713372; Daily oral administration
Experimental: Dose Expansion (Intervention Cohort 5); Dose expansion with BAY 3713372 monotherapy in participants with MTAP-deleted pancreatic ductal adenocarcinoma (PDAC).	Drug: BAY 3713372; Daily oral administration
Experimental: Dose Expansion (Intervention Cohort 6); Dose expansion with BAY 3713372 in combination with other treatments in participants with MTAP-deleted PDAC.	Drug: BAY 3713372; Daily oral administration
Experimental: Window-of-opportunity trial in participants with MTAP-deleted GBM (Intervention Cohort 7); A surgical window-of-opportunity trial of BAY 3713372 alone in participants with MTAP-deleted glioblastoma (GBM).	Drug: BAY 3713372; Daily oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)	TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent serious adverse events (TESAEs)	TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Escalation (Master and Intervention Cohort 1): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)	TEAEs and TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Escalation (Master and Intervention Cohort 1): Incidence of dose-limiting toxicities (DLTs)	DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0	From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTs	Number of participants with at least one DLT	From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372		From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372		From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days)
Dose Expansion (Master, Intervention Cohorts 1 - 6): Objective response rate (ORR)	Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	Approximately 1.5 years
Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTs	Number of participants with at least one DLT	From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)
Intervention Cohort 7: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)	TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Intervention Cohort 7: Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)	TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Intervention Cohort 7: Number of participants with DLTs	Number of participants with at least one DLT	From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days)
Intervention Cohort 7: Brain and brain tumor PK concentration of BAY 3713372	Concentration of BAY 3713372 in enhancing and non-enhancing brain tumor tissue obtained at definitive surgery, with corresponding time-matched plasma concentrations and estimation of tumor-to-plasma exposure ratios	From first dose through day of surgery (approximately 7 ± 2 days)
ntervention Cohort 7: Tumor tissue SDMA levels	Change in symmetric dimethylarginine (SDMA) levels in brain tumor tissue collected at definitive surgery following neoadjuvant BAY 3713372 treatment, as a pharmacodynamic marker of PRMT5 inhibition	From first dose through day of surgery (approximately 7 ± 2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation (Master and Intervention Cohort 1): Objective response rate (ORR)	Determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	Approximately 1.5 years
Dose Escalation (Master and Intervention Cohort 1): Duration of response (DOR)	Determined by the investigator according to RECIST v1.1	Approximately 3 years
Dose Escalation (Master and Intervention Cohort 1): Progression-free survival (PFS)	Determined by the investigator according to RECIST v1.1	Approximately 3 years
Dose Escalation (Master and Intervention Cohort 1): Time to response (TTR)		Approximately 1.5 years
Dose Expansion (Master, Intervention Cohorts 1 - 6): Number of participants with treatment-emergent adverse events (TEAEs)	TEAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Expansion (Master, Intervention Cohorts 1 - 6): Number of participants with treatment-emergent serious adverse events (TESAEs)	TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Expansion (Master, Intervention Cohorts 1 - 6): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)	TEAEs and TESAEs will be graded according to NCI-CTCAE v.5.0 and will be reported using the latest version of MedDRA coding dictionary	From the first administration of study intervention up to 30 days after the last dose of study intervention
Dose Expansion (Master, Intervention Cohorts 1, 3, 4, and 6): Incidence of dose-limiting toxicities (DLTs)	DLTs per participants. DLTs will be graded according to NCI-CTCAE v.5.0	From the first dose of study intervention to the end of Cycle 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)
Dose Expansion (Master, Intervention Cohorts 1 - 6): Duration of response (DOR)	Determined by the investigator according to RECIST v1.1	Approximately 3 years
Dose Expansion (Master, Intervention Cohorts 1 - 6): Progression-free survival (PFS)	Determined by the investigator according to RECIST v1.1	Approximately 3 years
Dose Expansion (Master, Intervention Cohorts 1 - 6): Time to response (TTR)		Approximately 1.5 years
Dose Expansion (Master, Intervention Cohorts 1 - 4, and 6): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372		From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)
Dose Expansion (Master, Intervention Cohorts 1 - 4, and 6): Area under the curve (AUC) of the respective dosing interval of BAY 3713372		From the first dose of study intervention up to Cycle 2 Day 1 (each cycle is 21 days, except for Intervention Cohort 6, which has a cycle length of 28 days)
Dose Expansion (Part A of Intenvention Cohort 2): Time to CNS progression (CNS-TTP)		Approximately 3 years
Dose Expansion (Part B of Intervention Cohort 2): CNS-ORR for active brain metastases	CNS-ORR: CNS objective response rate	Approximately 1.5 years
Dose Expansion (Part B of Intervention Cohort 2): CNS-DOR for active brain metastases	CNS-DOR: Duration of CNS response	Approximately 3 years
Dose Expansion (Part B of Intervention Cohort 2): CNS-PFS for active brain metastases	CNS-PFS: Survival without CNS progression	Approximately 3 years
Dose Expansion (Part B of Intervention Cohort 2): CNS-TTR for active brain metastases	CNS-TTR: Time to CNS response	Approximately 1.5 years
Dose Expansion (Part B of Intervention Cohort 2): CNS-related disease control rate (CNS-DCR) in active brain metastases		Approximately 1.5 years

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Estimated): June 17, 2029
• Study Completion (Estimated): June 17, 2029

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; GBM; Non-small cell lung cancer; Glioblastoma; Solid Tumors; Pancreatic adenocarcinoma; PDAC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Glioblastoma; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 22931; 2025-520623-24-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No