Clinical trial • Phase I/II • Oncology
OSIMERTINIB MESYLATE for Advanced solid tumors | Non-small cell lung cancer (EGFR-mutant) | Non-small cell lung cancer (EGFR-wildtype)
Phase I/II trial of OSIMERTINIB MESYLATE for Advanced solid tumors | Non-small cell lung cancer (EGFR-mutant) | Non-small cell lung cancer (EGFR-wildtype).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors | Non-small cell lung cancer (EGFR-mutant) | Non-small cell lung cancer (EGFR-wildtype)
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule | Monoclonal antibody | ADC
Key dates
- Initial CTIS Submission Date
- 08-01-2025
- First CTIS Authorization Date
- 08-04-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 24 sites in Spain, Netherlands, France and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True - Dose-finding escalation design with DLT evaluation to determine maximum safe dose and select doses for expansion.
- Biomarker Stratified
- True, biomarker: EGFR mutation status (EGFR-mutant vs EGFR-wildtype)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 168
Eligibility
Recruits 168 No vulnerable population selected; trial enrols adults only. Informed consent obtained from participants; no assent/child consent procedures described..
- Vulnerable Population
- No vulnerable population selected; trial enrols adults only. Informed consent obtained from participants; no assent/child consent procedures described.
Inclusion criteria
- {"criterion_text":"- Participants must have at least one measurable lesion per response evaluation criteria in solid tumors."}
- {"criterion_text":"- Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1."}
- {"criterion_text":"- Participants must have a life expectancy of at least 3 months at the time of the first dose."}
Exclusion criteria
- {"criterion_text":"- Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology."}
- {"criterion_text":"- Participants with spinal cord compression, symptomatic central nervous system (CNS) metastases, progression of existing CNS metastases, or the appearance of new lesions as shown on CNS imaging during screening will be excluded."}
- {"criterion_text":"- Participants must not have a history of serious recurrent infections."}
- {"criterion_text":"- Participants must not have a history of severe heart disease."}
- {"criterion_text":"- Other protocol-defined Inclusion/Exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of participants with adverse events (AEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of participants with serious adverse events (SAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of participants with AEs leading to discontinuation","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of participants with AEs leading to death","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number of DLTs that occur during the DLT evaluation period","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Maximum observed serum concentration (Cmax)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time of maximum observed concentration (Tmax)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))","definition_or_measurement_approach":""}
- {"endpoint_text":"- Area under the serum concentration-time curve within a dosing interval (AUC(TAU))","definition_or_measurement_approach":""}
- {"endpoint_text":"- Objective response rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Best Overall Response (BOR)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 168
- Recruitment Window Months
- 42
- Consent Approach
- Informed consent obtained from adult participants; subject information and informed consent forms (L1 SIS and ICF) provided in multiple languages (English, Spanish, Dutch, French, Italian) as per submitted documents. No assent or child consent procedures described.
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 108
Spain
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 17-07-2025
- Processing Time Days
- 125
- Number Of Sites
- 10
- Number Of Participants
- 33
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncologia
- Principal Investigator Name
- Alejandro Navarro
- Principal Investigator Email
- afnavarro@clinic.cat
- Contact Person Name
- Alejandro Navarro
- Contact Person Email
- afnavarro@clinic.cat
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncologia
- Principal Investigator Name
- Noelia Vilarino
- Principal Investigator Email
- nvilarino@iconcologia.net
- Contact Person Name
- Noelia Vilarino
- Contact Person Email
- nvilarino@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Luis Paz-Ares
- Principal Investigator Email
- lpazares@hotmail.com
- Contact Person Name
- Luis Paz-Ares
- Contact Person Email
- lpazares@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncologia-VHIO
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- START Madrid
- Principal Investigator Name
- Ramon Yarza
- Principal Investigator Email
- ramon.yarza@startmadrid.com
- Contact Person Name
- Ramon Yarza
- Contact Person Email
- ramon.yarza@startmadrid.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- START Madrid - FJD
- Principal Investigator Name
- Ester Garcia Lozano
- Principal Investigator Email
- ester.garcia@startmadrid.com
- Contact Person Name
- Ester Garcia Lozano
- Contact Person Email
- ester.garcia@startmadrid.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncologia
- Principal Investigator Name
- Mariano Provencio
- Principal Investigator Email
- mprovencio.ensayosclinicos@xxx.com
- Contact Person Name
- Mariano Provencio
- Contact Person Email
- mprovencio.ensayosclinicos@xxx.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncologia
- Principal Investigator Name
- Jorge Garcia
- Principal Investigator Email
- jorge.jose.garcia.gonzalez@sergas.es
- Contact Person Name
- Jorge Garcia
- Contact Person Email
- jorge.jose.garcia.gonzalez@sergas.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncologia
- Principal Investigator Name
- Oscar Juan
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar Juan
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncologia
- Principal Investigator Name
- Manuel Cobo
- Principal Investigator Email
- manuelcobodols@xxx.es
- Contact Person Name
- Manuel Cobo
- Contact Person Email
- manuelcobodols@xxx.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 18-07-2025
- Processing Time Days
- 123
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Pulmonology
- Principal Investigator Name
- Egbert Smit
- Principal Investigator Email
- e.f.smit@lumc.nl
- Contact Person Name
- Egbert Smit
- Contact Person Email
- e.f.smit@lumc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Pulmonology
- Principal Investigator Name
- Gerrina Ruiter
- Principal Investigator Email
- g.ruiter@nki.nl
- Contact Person Name
- Gerrina Ruiter
- Contact Person Email
- g.ruiter@nki.nl
France
- Earliest CTIS Part Ii Submission Date
- 22-10-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 16
- Number Of Sites
- 7
- Number Of Participants
- 27
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laurent GREILLIER
- Principal Investigator Email
- laurent.greillier@ap-hm.fr
- Contact Person Name
- Laurent GREILLIER
- Contact Person Email
- laurent.greillier@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Pulmonology department
- Principal Investigator Name
- Benoît ROCH
- Principal Investigator Email
- b-roch@chu-montpellier.fr
- Contact Person Name
- Benoît ROCH
- Contact Person Email
- b-roch@chu-montpellier.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sophie COUSIN
- Principal Investigator Email
- s.cousin@bordeaux.unicancer.fr
- Contact Person Name
- Sophie COUSIN
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Aurelie SWALDUZ
- Principal Investigator Email
- aurelie.swalduz@lyon.unicancer.fr
- Contact Person Name
- Aurelie SWALDUZ
- Contact Person Email
- aurelie.swalduz@lyon.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Thoracic oncology
- Principal Investigator Name
- David PLANCHARD
- Principal Investigator Email
- david.planchard@gustaveroussy.fr
- Contact Person Name
- David PLANCHARD
- Contact Person Email
- david.planchard@gustaveroussy.fr
- Site Name
- Hopital Tenon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jacques CADRANEL
- Principal Investigator Email
- jacques.cadranel@aphp.fr
- Contact Person Name
- Jacques CADRANEL
- Contact Person Email
- jacques.cadranel@aphp.fr
- Site Name
- Institut Curie
- Department Name
- Pneumology
- Principal Investigator Name
- Nicolas GIRARD
- Principal Investigator Email
- nicolas.girard2@curie.fr
- Contact Person Name
- Nicolas GIRARD
- Contact Person Email
- nicolas.girard2@curie.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 14-10-2025
- Latest Decision Or Authorization Date
- 03-12-2025
- Processing Time Days
- 50
- Number Of Sites
- 5
- Number Of Participants
- 31
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- S.C Oncologia Medica 1
- Principal Investigator Name
- Giuseppe Lo Russo
- Principal Investigator Email
- giuseppe.lorusso@istitutotumori.mi.it
- Contact Person Name
- Giuseppe Lo Russo
- Contact Person Email
- giuseppe.lorusso@istitutotumori.mi.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- Oncologia medica e dei tumori immuno-correlati
- Principal Investigator Name
- Alessandra Bearz
- Principal Investigator Email
- alessandra.bearz@cro.it
- Contact Person Name
- Alessandra Bearz
- Contact Person Email
- alessandra.bearz@cro.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Daniele Daniele
- Principal Investigator Email
- gennaro.daniele@policlinicogemelli.it
- Contact Person Name
- Daniele Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Oncologia
- Principal Investigator Name
- Lorenzo Antonuzzo
- Principal Investigator Email
- lorenzo.antonuzzo@gmail.com
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- lorenzo.antonuzzo@gmail.com
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Vanessa Gregorc
- Principal Investigator Email
- vanesa.gregorc@ircc.it
- Contact Person Name
- Vanessa Gregorc
- Contact Person Email
- vanesa.gregorc@ircc.it
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Serology/ endocrinology, Medical image analysis/ review - X-ray, MRI, ultrasound, etc.
- Name
- Iqvia Holdings Inc.
- Responsibilities
- Monitoring, Regulatory, Investigator recruitment,Data management, SUSAR reporting, Quality assurance auditing, Statistical analysis,Medical writing
- Name
- Endpoint Clinical Inc.
- Responsibilities
- Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment
Third parties
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Serology/ endocrinology, Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Monitoring, Regulatory, Investigator recruitment,Data management, SUSAR reporting, Quality assurance auditing, Statistical analysis,Medical writing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Industry"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":",Tumor blocks/slides storage,PGX spl, spl storage for vendors,IHC,Legacy LabCorp Central Lab.; Routine clinical pathology testing,Clinical chemistry, Clinical haematology, Clinical microbiology","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Emsere","duties_or_roles":"bulk supply/ancillary supply provider","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- OSIMERTINIB MESYLATE
- Active Substance
- OSIMERTINIB MESYLATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- PEMBROLIZUMAB
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Investigational Product Name
- BL-B01D1
- Active Substance
- IZALONTAMAB BRENGITECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Combination Treatment
- Yes
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