Clinical trial • Phase I/II • Oncology
TELISOTUZUMAB ADIZUTECAN for Non-small cell lung cancer (non-squamous, advanced or metastatic)
Phase I/II trial of TELISOTUZUMAB ADIZUTECAN for Non-small cell lung cancer (non-squamous, advanced or metastatic).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (non-squamous, advanced or metastatic)
- Trial Stage
- Phase I/II
- Drug Modality
- ADC | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 29-11-2024
- First CTIS Authorization Date
- 07-04-2025
Trial design
Randomised, open-label, alimta (pemetrexed) 500 mg powder for concentrate for solution for infusion (intravenous) — comparator; carboplatin 10 mg/ml intravenous infusion (intravenous) — comparator; cisplatin 1 mg/ml injection bp (intravenous) — comparator; keytruda (pembrolizumab) 25 mg/ml concentrate for solution for infusion (intravenous) — comparator. schedule/doses not specified in source json.-controlled, adaptive Phase I/II trial across 49 sites in France, Germany, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- ALIMTA (pemetrexed) 500 mg powder for concentrate for solution for infusion (intravenous) — comparator; Carboplatin 10 mg/ml Intravenous Infusion (intravenous) — comparator; Cisplatin 1 mg/ml Injection BP (intravenous) — comparator; KEYTRUDA (pembrolizumab) 25 mg/mL concentrate for solution for infusion (intravenous) — comparator. Schedule/doses not specified in source JSON.
- Adaptive
- True, dose-escalation in Part 1 with evaluation of dose-limiting toxicities to determine the recommended Phase 3 dose (RP3D); specific escalation rules, interim analyses, or stopping rules not provided in the JSON.
- Biomarker Stratified
- True, PD-L1 and c-Met subgroups
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 156
Eligibility
Recruits 156 No vulnerable populations selected; adults only. Informed consent is required from each participant; no assent procedures specified..
- Vulnerable Population
- No vulnerable populations selected; adults only. Informed consent is required from each participant; no assent procedures specified.
Inclusion criteria
- {"criterion_text":"- Subject must have had no prior systemic therapy for locally advanced or metastatic NSCLC including PD-L1/PD-L2 inhibitor, CTLA-4 inhibitor, TIM 3 inhibitors, or any other immunotherapy Subject may have received prior adjuvant/neoadjuvant systemic therapy and/or radiation as defined in protocol (Allowed for 1L pts), in both parts.\n- Subject must have received 1 line of prior systemic therapy in the locally advanced or metastatic setting (Neoadjuvant and adjuvant systemic therapy would count as a prior line). Eligibility for subjects with or without actionable gene alterations will be defined in protocol (Allowed for 2L pts), on part 1 only."}
Exclusion criteria
- {"criterion_text":"- For 1L subjects in Part 1 and 2: Subjects with EGFR or other genomic aberration (e.g., ALK, ROS1, KRAS G12C, BRAFV600E, NTRK1,2,3, RET1, HER-2, MET exon 14 skipping, etc.) for which a locally approved targeted therapy is available for first-line treatment.\n- Subject with prior treatment of a c-Met targeting antibody (e.g., ABBV-400, ABBV-399 or topoisomerase-inhibitor containing regimen. Prior treatment with MET tyrosine kinase inhibitors is allowed.\n- 3. Subject with known uncontrolled metastases to the CNS."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part 1: dose-limiting toxicity.","definition_or_measurement_approach":"Part 1 primary endpoint is dose-limiting toxicity (DLT); used to assess safety/tolerability and determine the recommended Phase 3 dose (RP3D) in dose-escalation."}
- {"endpoint_text":"- Part 2: efficacy endpoint is the OR as assessed by BICR (as confirmed CR or PR based on RECIST v1.1).","definition_or_measurement_approach":"Objective Response (OR) assessed by Blinded Independent Central Review (BICR); confirmed complete response (CR) or partial response (PR) per RECIST v1.1."}
Secondary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS): the time from the subject's randomization date to the first occurrence of radiographic progression per BICR based on RECIST v1.1 or death from any cause, whichever occurs earlier.","definition_or_measurement_approach":"Time from randomization to first radiographic progression per BICR using RECIST v1.1 or death from any cause."}
- {"endpoint_text":"- Duration Of Response (DOR): the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Time from first documented CR/PR by BICR to radiographic progression per RECIST v1.1 or death."}
- {"endpoint_text":"- Disease Control: best overall response of confirmed CR or confirmed PR, or SD for at least 11 weeks following randomization date based on RECIST v1.1, by the BICR. OR, PFS, DOR, and DC by investigator per RECIST v1.1.","definition_or_measurement_approach":"Best overall response per BICR (confirmed CR/PR or stable disease ≥11 weeks) using RECIST v1.1; includes investigator-assessed OR, PFS, DOR, and disease control per RECIST v1.1."}
- {"endpoint_text":"- Overall Survival: the time from subject's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause. Subjects with no documented death will be censored at the last known alive date.","definition_or_measurement_approach":"Time from randomization (Part 2) or first dose (Part 1) to death from any cause; censoring at last known alive date."}
- {"endpoint_text":"- OR, PFS, OS, DOR, and DC in PD-L1 and c-Met subgroups.","definition_or_measurement_approach":"Efficacy endpoints (OR, PFS, OS, DOR, disease control) evaluated within PD-L1 and c-Met biomarker-defined subgroups."}
Recruitment
- Planned Sample Size
- 156
- Recruitment Window Months
- 30
- Consent Approach
- Informed consent is obtained from adult participants at each site. Site-specific ICF documents include Part 1 and Part 2 forms, optional parts, and pregnant-partner information where applicable. ICFs are provided in country languages as published (examples in the dossier: French, German, Italian, Romanian, Polish, Dutch, English, Spanish). No assent procedures for minors are specified.
Geography
- Total Number Of Sites
- 49
- Total Number Of Participants
- 96
France
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 401
- Number Of Sites
- 9
- Number Of Participants
- 18
Sites
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncology
- Contact Person Name
- Victoria Ferrari
- Contact Person Email
- victoria.ferrari@nice.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Institut Bergonié, medical oncology department
- Contact Person Name
- Sophie COUSIN
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Oncology Medical Department - Oncology thoracic Unit
- Contact Person Name
- Elvire PONS-TOSTIVINT
- Contact Person Email
- elvire.pons@chu-nantes.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical oncology
- Contact Person Name
- Judith Raimbourg
- Contact Person Email
- judith.raimbourg@ico.unicancer.fr
- Site Name
- Centre De Cancerologue Du Grand Montpellier
- Department Name
- Oncology
- Contact Person Name
- Catherine Becht
- Contact Person Email
- lancelot@ccgm.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical oncology
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Institut Curie
- Department Name
- Pneumology
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curie.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Drug Development Department (DITEP)
- Contact Person Name
- GAZZAH Anas
- Contact Person Email
- anas.gazzah@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Department of Medical Oncology
- Contact Person Name
- SWALDUZ Aurélie
- Contact Person Email
- aurelie.swalduz@lyon.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 399
- Number Of Sites
- 9
- Number Of Participants
- 18
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Comprehensive Cancer Center Mainfranken
- Contact Person Name
- Horst-Dieter Hummel
- Contact Person Email
- isz_koordination@ukw.de
- Site Name
- Haematologie-Onkologie im Zentrum MVZ GmbH
- Department Name
- Klinik fuer Haematologie, Onkologie und Immunologie
- Contact Person Name
- Bernhard Heinrich
- Contact Person Email
- bernhard.heinrich@hop-augsburg.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Department of Internal Medicine I
- Contact Person Name
- Christine Greil
- Contact Person Email
- med1.kontakt.studienzentrale@list.uniklinik-freiburg.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Med. Klinik 2
- Contact Person Name
- Fabian Acker
- Contact Person Email
- acker@med.uni-frankfurt.de
- Site Name
- ohO Research GmbH
- Department Name
- Klinik fuer Haematologie, Onkologie und Immunologie
- Contact Person Name
- Gerdt Huebner
- Contact Person Email
- g.huebner@oho-research.de
- Site Name
- SLK-Kliniken Heilbronn GmbH
- Department Name
- Med. Klinik II Onkologie mit Palliativmedizin
- Contact Person Name
- Jonas Kuon
- Contact Person Email
- onkologie.kloe@slk-kliniken.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Abteilung Hämatologie und Internistische Onkologie
- Contact Person Name
- Jakob Hammersen
- Contact Person Email
- kim2-studienzentrale@med.uni-jena.de
- Site Name
- Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
- Department Name
- Department of Pneumology
- Contact Person Name
- Karsten Schulmann
- Contact Person Email
- Karsten.schulmann@lkhemer.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Department I for internal medicine
- Contact Person Name
- Richard Riedel
- Contact Person Email
- lungenkrebs@uk-koeln.de
Italy
- Earliest CTIS Part Ii Submission Date
- 19-03-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 397
- Number Of Sites
- 7
- Number Of Participants
- 14
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Oncology-Hematology
- Contact Person Name
- Francesco Gelsomino
- Contact Person Email
- francesco_gelsomino@aosp.bo.it
- Site Name
- Azienda Ospedaliera S Giovanni Addolorata
- Department Name
- UON Oncology
- Contact Person Name
- Antonio Lugini
- Contact Person Email
- alugini@hsangiovanni.roma.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Clinica Oncologica
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- rossana.berardi@ospedaliriuniti.marche.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Thoracic Oncology Division
- Contact Person Name
- Gianluca Spitaleri
- Contact Person Email
- gianluca.spitaleri@ieo.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Toracica
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- UOSD Clinical Trials Unit: Phase 1 and Precision Medicine
- Contact Person Name
- Lorenza Landi
- Contact Person Email
- lorenza.landi@ifo.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- SCDU Medical Oncology
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
Romania
- Earliest CTIS Part Ii Submission Date
- 19-03-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 401
- Number Of Sites
- 7
- Number Of Participants
- 14
Sites
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Radiotherapy Center Cluj S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Andrei Ungureanu
- Contact Person Email
- andreiungureanu.oncolog@yahoo.com
- Site Name
- Mnt Healthcare Europe S.R.L.
- Department Name
- MNT Healthcare Europe SRL
- Contact Person Name
- Bogdan Georgescu
- Contact Person Email
- dr_bogdan.georgescu@icloud.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Contact Person Name
- Milan-Paul Kubelac
- Contact Person Email
- paulkubelac@gmail.com
- Site Name
- Clinica Polisano S.R.L.
- Department Name
- Clinica MedLife Polisano
- Contact Person Name
- Victor Nimirceag
- Contact Person Email
- dr.nimirceag@gmail.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Institutul Oncologic Prof Dr I Chiricuta
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
- Site Name
- Spitalul Clinic Coltea
- Department Name
- Oncology
- Contact Person Name
- Raluca Ileana Patru
- Contact Person Email
- raluca.patru@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 403
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badan Klinicznych UCK Osrodek Badan Klinicznych Wczesnych Faz
- Contact Person Name
- Katarzyna Szymczak
- Contact Person Email
- kszymczak@uck.gda.pl
- Site Name
- Provita Centrum Medyczne Sp. z o.o.
- Contact Person Name
- Magdalena Ciazynska
- Contact Person Email
- magdalena.ciazynska@nu-med.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
- Contact Person Name
- Robert Mroz
- Contact Person Email
- robmmroz@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Oddzial Wieloprofilowy Zachowawczy
- Contact Person Name
- Izabela Chmielewska
- Contact Person Email
- izachm@wp.pl
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Onkologii Klinicznej
- Contact Person Name
- Tomasz Kucharczyk
- Contact Person Email
- badania.kliniczne@onkol.kielce.pl
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-03-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 396
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- CHC MontLegia
- Department Name
- Oncology
- Contact Person Name
- Maryam Bourhaba
- Contact Person Email
- maryam.bourhaba@chc.be
- Site Name
- Vitaz
- Department Name
- Oncology
- Contact Person Name
- Koen Deschepper
- Contact Person Email
- koen.deschepper@vitaz.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Oncology
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- kristof.cuppens@jessazh.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Oncology
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- ingel.demedts@azdelta.be
Spain
- Earliest CTIS Part Ii Submission Date
- 18-03-2025
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 400
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology
- Contact Person Name
- Marta López-Brea Piqueras
- Contact Person Email
- martafrancisca.lopezbrea@scsalud.es
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Oncology
- Contact Person Name
- Bartomeu Massuti Surerda
- Contact Person Email
- bmassutis@seom.org
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Oncology
- Contact Person Name
- David Vicente Baz
- Contact Person Email
- david.vbaz@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Laura Mezquita Pérez
- Contact Person Email
- lmezquita@clinic.cat
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Contact Person Name
- Maria del Rosario Garcia Campelo
- Contact Person Email
- ensayos.clinicos.onco.asacec@sergas.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Contact Person Name
- Jose Carlos Benitez Montañez
- Contact Person Email
- fasestempranas@ibima.eu
- Site Name
- Hospital Del Mar
- Department Name
- Oncology
- Contact Person Name
- Edurne Arriola Aperribay
- Contact Person Email
- earriola@parcdesalutmar.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Oncology
- Contact Person Name
- Margarita Majem
- Contact Person Email
- mmajem@santpau.cat
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- WCG Clinical Inc.
- Responsibilities
- ILD adjucation committee
- Name
- Endpoint Clinical Inc.
- Responsibilities
- code 3
- Name
- Clario
- Responsibilities
- Imaging
- Name
- Medidata Solutions Inc.
- Responsibilities
- Patient Reported Outcomes (eCOA); code 7
- Name
- Veeva Systems Inc.
- Responsibilities
- code 7
Third parties
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"ILD adjucation committee","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Tissue Diagnostics","duties_or_roles":"code 4","organisation_type":"Industry"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"code 2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Patient Reported Outcomes (eCOA); code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clario","duties_or_roles":"Imaging","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Telisotuzumab adizutecan
- Active Substance
- TELISOTUZUMAB ADIZUTECAN
- Modality
- ADC
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Investigational Product Name
- Budigalimab
- Active Substance
- BUDIGALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Investigational Product Name
- ALIMTA (pemetrexed)
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- EU/1/04/290/001
- Investigational Product Name
- Carboplatin 10 mg/ml Intravenous Infusion
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- PL 04515/0050
- Investigational Product Name
- Cisplatin 1mg/ml Injection BP
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- PL 04416/1597
- Investigational Product Name
- KEYTRUDA (pembrolizumab)
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- EU/1/15/1024/002
- Combination Treatment
- Yes
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