Clinical trial • Phase II • Oncology

AMG 193 for Non-small cell lung cancer | MTAP-deleted non-small cell lung cancer

Phase II trial of AMG 193 for Non-small cell lung cancer | MTAP-deleted non-small cell lung cancer. Randomised, open-label, adaptive. 104 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | MTAP-deleted non-small cell lung cancer
Trial Stage
Phase II
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
25-10-2024
First CTIS Authorization Date
04-03-2025

Trial design

Randomised, open-label, adaptive Phase II trial in Belgium, Czechia, France and others.

Randomised
Yes
Open Label
Yes
Adaptive
True, Part 1 is a randomized dose optimization evaluating two active dose levels with selection of the dose level to be evaluated in Part 2 (dose selection/optimization design). No further adaptive rules (interim analyses/stopping rules) are specified in the provided data.
Biomarker Stratified
True, MTAP deletion
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
104

Eligibility

Recruits 104 paediatric patients.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer.\n- Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.\n- Either an archival tissue sample or an archival block must be available.\n- Life expectancy of greater than 3 months, in the opinion of the investigator.\n- Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.\n- Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible."}

Exclusion criteria

  • {"criterion_text":"- Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).\n- Major surgery within 28 days of study day 1.\n- Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)","definition_or_measurement_approach":"Measured by CT or MRI and assessed per RECIST v1.1; includes CR and PR."}
  • {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs)","definition_or_measurement_approach":"Incidence and severity grading of TEAEs, recording of grade ≥3 TEAEs, SAEs and EOIs per standard safety reporting and severity grading scales (e.g., CTCAE)."}
  • {"endpoint_text":"- Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC)","definition_or_measurement_approach":"Standard PK sampling and analysis to derive parameters such as Cmax, Tmax and AUC from plasma concentration-time data."}
  • {"endpoint_text":"- OR (CR and PR) per RECIST 1.1","definition_or_measurement_approach":"Objective response (CR and PR) defined and assessed according to RECIST 1.1."}

Secondary endpoints

  • {"endpoint_text":"- Disease control (DC), Duration of response (DOR), Time to response (TTR), Progression free survival (PFS)","definition_or_measurement_approach":"Standard oncologic outcome measures assessed by investigator and/or central review (e.g., time-to-event analyses for DOR, TTR, PFS; disease control per RECIST/response criteria)."}
  • {"endpoint_text":"- OR (CR and PR), DC, DOR, TTR, PFS","definition_or_measurement_approach":"As above; OR and related time-to-event efficacy endpoints evaluated per RECIST 1.1."}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Time from randomization/enrollment to death from any cause; standard survival analysis."}
  • {"endpoint_text":"- Incidence and severity of TEAEs, grade ≥ 3 TEAEs, SAEs, and EOIs","definition_or_measurement_approach":"Safety monitoring and reporting including grading of adverse events (e.g., CTCAE) and classification of SAEs/EOIs."}
  • {"endpoint_text":"- PK parameters of AMG 193 including, but not limited to Cmax, Tmax, and AUC","definition_or_measurement_approach":"Pharmacokinetic sampling and analysis to derive Cmax, Tmax, AUC, etc."}
  • {"endpoint_text":"- Changes in cancer-specific symptoms, treatment-related symptom and overall health status using subject-reported outcome instruments: o EORTC QLQ-C30 o QLQ LC13 o EQ-5D-5L o PRO-CTCAE o GP5 of FACT-G","definition_or_measurement_approach":"Patient-reported outcome measures collected using specified instruments (EORTC QLQ-C30, QLQ-LC13, EQ-5D-5L, PRO-CTCAE, FACT-G GP5) to evaluate symptom and health-status changes."}

Recruitment

Planned Sample Size
104
Recruitment Window Months
44
Consent Approach
Informed consent is obtained using study-specific subject information sheets and informed consent forms (ICFs). Age-specific documents are provided (prescreening ICFs, main ICF, pregnancy consent forms, and child/parent ICFs exist), and parental consent/parental permission materials for child participants are available (documents titled 'L1_SIS and ICF Child Father' and 'L1_SIS and ICF Child Mother' are included). Consent materials are available in multiple languages (English, French, Dutch, German, Spanish, Italian, Portuguese, Polish, Hungarian, Greek, Czech, Latvian and Russian as indicated by document variants). Pregnancy-specific consent/follow-up forms are also provided.

Geography

Total Number Of Sites
65
Total Number Of Participants
107

Belgium

Earliest CTIS Part Ii Submission Date
24-01-2025
Latest Decision Or Authorization Date
04-03-2025
Processing Time Days
39
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Antwerp University Hospital
Department Name
Pulmonology
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be
Site Name
UZ Leuven
Department Name
Respiratory Oncology
Contact Person Name
Els Wauters
Contact Person Email
els.wauters@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Pulmonology
Contact Person Name
Dieter Stevens
Contact Person Email
dieter.stevens@uzgent.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pulmonology
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be

Czechia

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
04-03-2025
Processing Time Days
11
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Fakultni Thomayerova nemocnice
Contact Person Name
Marie Drosslerova
Contact Person Email
marie.drosslerova@ftn.cz
Site Name
University Hospital Olomouc
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Contact Person Name
Milada Zemanova
Contact Person Email
milada.zemanova@vfn.cz
Site Name
Masarykuv Onkologicky Ustav
Contact Person Name
Stanislav Spelda
Contact Person Email
spelda@mou.cz

France

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
48
Number Of Sites
8
Number Of Participants
9

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service de Pneumologie
Contact Person Name
Julien MAZIERES
Contact Person Email
mazieres.j@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Oncologie Thoracique
Contact Person Name
Gérard ZALCMAN
Contact Person Email
gerard.zalcman@aphp.fr
Site Name
Institut Bergonie
Department Name
Service d'Oncologie Médicale
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service D’Oncologie Multidisciplinaire et Innovations Thérapeutiques
Contact Person Name
Laurent GREILLIER
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
Institut Gustave Roussy
Department Name
Service Pneumologie
Contact Person Name
Benjamin BESSE
Site Name
Institut De Cancerologie De L Ouest
Department Name
Service Oncologie
Contact Person Name
Sandrine HIRET
Contact Person Email
s-hiret@nantes.fnclcc.fr
Site Name
Institut Curie
Department Name
Service de Pneumologie
Contact Person Name
Nicolas GIRARD
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service de Pneumologie et d’Oncologie Thoracique
Contact Person Name
Arnaud SCHERPEREEL

Germany

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
05-03-2025
Processing Time Days
86
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Comprehensive Cancer Center Mainfranken Interdisciplinary Study Center - Early Clinical Trial Unit
Contact Person Name
Horst-Dieter Hummel
Contact Person Email
hummel_h@ukw.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Thoracic Oncology
Contact Person Name
Martin Reck
Contact Person Email
a.gaebler@lungenclinic.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoracic Oncology
Contact Person Name
Farastuk Bozorgmehr
Site Name
Universitaetsklinikum Essen AöR
Department Name
Medical Oncology
Contact Person Name
Halime Kalkavan
Contact Person Email
halime.kalkavan@uk-essen.de
Site Name
Technische Universitaet Dresden
Department Name
Internal Medicine 1
Contact Person Name
Martin Wermke

Greece

Earliest CTIS Part Ii Submission Date
03-02-2025
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
31
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Metropolitan Hospital
Department Name
2nd Oncology Department
Contact Person Name
Epaminondas Samantas
Contact Person Email
epsam@otenet.gr
Site Name
Henry Dunant Hospital Center
Department Name
4th Oncology Department and Clinical Trial Units
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Medical Oncology Unit
Contact Person Name
Sofia Agelaki
Contact Person Email
agelaki@med.uoc.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd Department of Internal Medicine
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Department Name
5th Oncology Clinic
Contact Person Name
Theofanis Floros
Site Name
University General Hospital Attikon
Department Name
2nd Propaedeutic Internal Medicine Clinic, Oncology Department
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Bioclinic S.A.
Department Name
Oncology Department
Contact Person Name
Ioannis Boukovinas
Contact Person Email
ibouk@otenet.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Contact Person Name
Eleni Fountzila
Contact Person Email
elenafou@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
07-03-2025
Processing Time Days
86
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Farkasgyepui Tudogyogyintezet
Department Name
I Pulmonologia
Contact Person Name
Zsolt Kiraly
Contact Person Email
dr.kiraly.zsolt@gmail.com
Site Name
Semmelweis University
Department Name
Pulmonologiai Klinika
Contact Person Name
Veronika Muller
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
VI Pulmonologiai Osztaly
Contact Person Name
Andrea Fulop
Contact Person Email
afulop64@gmail.com
Site Name
Matrai Gyogyintezet
Department Name
III Pulmonologia
Contact Person Name
Istvan Albert
Contact Person Email
albert.magy@gmail.com
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pulmonologiai Osztaly
Contact Person Name
Zsuzsanna Szalai
Contact Person Email
clinstudy@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
05-02-2025
Latest Decision Or Authorization Date
05-03-2025
Processing Time Days
28
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia
Contact Person Name
Emilio Bria
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncologia
Contact Person Name
Giovanna Finocchiaro
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncologia
Contact Person Name
Sara Pilotto
Contact Person Email
sara.pilotto@univr.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Oncologia
Contact Person Name
Iacopo Petrini
Contact Person Email
i.petrini@ao-pisa.toscana.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia
Contact Person Name
Claudia Proto
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncologia
Contact Person Name
Paolo Bironzo
Contact Person Email
paolo.bironzo@unito.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l. (listed)
Department Name
Oncologia
Contact Person Name
Sara Pilotto
Contact Person Email
sara.pilotto@univr.it

Latvia

Earliest CTIS Part Ii Submission Date
03-02-2025
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
31
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Rigas Austrumu kliniska universitates slimnica SIA
Department Name
Oncology
Contact Person Name
Zanete Zvirbule
Contact Person Email
zanete.zvirbule@aslimnica.lv
Site Name
Pauls Stradins Clinical University Hospital
Department Name
Oncology
Contact Person Name
Aija Gerina
Contact Person Email
a.gerina@inbox.lv

Netherlands

Earliest CTIS Part Ii Submission Date
27-02-2025
Latest Decision Or Authorization Date
07-03-2025
Processing Time Days
8
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Pulmonary Diseases
Contact Person Name
Joop de Langen
Contact Person Email
j.d.langen@nki.nl
Site Name
Ziekenhuis St Jansdal
Department Name
Pulmonary Medicine
Contact Person Name
Lisenka Boom
Contact Person Email
LN.Boom@stjansdal.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary Department
Contact Person Name
Anne-Marie Dingemans
Contact Person Email
a.dingemans@erasmusmc.nl

Portugal

Earliest CTIS Part Ii Submission Date
14-01-2025
Latest Decision Or Authorization Date
07-03-2025
Processing Time Days
52
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
Maria Cassiano Neves
Site Name
Hospital CUF Porto S.A.
Department Name
Serviço de Oncologia
Contact Person Name
Venceslau Hespanhol
Contact Person Email
venceslau.hespanhol@cuf.pt
Site Name
Champalimaud Clinical Centre
Department Name
Fundação Champalimaud
Contact Person Name
Marcos Pantarotto
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Oncologia Médica
Contact Person Name
Maria Pereira

Spain

Earliest CTIS Part Ii Submission Date
12-02-2025
Latest Decision Or Authorization Date
04-03-2025
Processing Time Days
20
Number Of Sites
8
Number Of Participants
13

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncologia
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazares@hotmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncologia
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Servicio de Oncologia Medica
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncologia
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhebron.net
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Servicio de Oncologia Medica
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Servicio de Oncologia
Contact Person Name
David Vicente Baz
Contact Person Email
dvicentebaz@yahoo.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Oncologia Medica
Contact Person Name
Alexandra Cantero Gonzalez
Site Name
Hospital Del Mar
Department Name
Servicio de Oncologia Medica
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
EArriola@parcdesalutmar.cat

Poland

Earliest CTIS Part Ii Submission Date
06-02-2025
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
28
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
Oncology
Contact Person Name
Mateusz Polaczek
Contact Person Email
m.polaczek@igichp.edu.pl
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oncology
Contact Person Name
Krzysztof Rogoziewicz
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oncology
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oncology
Contact Person Name
Maciej Krzakowski
Contact Person Email
lungcancer@pib-nio.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Oncology
Contact Person Name
Szymon Borowiec
Contact Person Email
sborowiec@wim.mil.pl
Site Name
Wojewodzki Szpital Specjalistyczny Nr 4 W Bytomiu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Oncology
Contact Person Name
Ewa Nowakowska-Zajdel
Site Name
Futuremeds Sp. z o.o.
Department Name
Oncology
Contact Person Name
Michal Parkitny
Contact Person Email
michal.parkitny@futuremeds.com

Sponsor

Primary sponsor

Full Name
Amgen Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Excelya Greece CRO Single Member S.A.
Responsibilities
CRA/CTA Provider for Greece
Name
Voiant LLC
Responsibilities
Central Imaging Vendor
Name
Kayentis
Responsibilities
eCOA and eDiary
Name
Suvoda LLC

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"Central Imaging Vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long Term Laboratory Storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"eCOA and eDiary","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"CRA/CTA Provider for Greece","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment Vendor","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AMG 193
Active Substance
AMG 193
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL

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