Clinical trial • Phase III • Oncology
SOTORASIB for Non-small cell lung cancer (KRAS p.G12C-mutated)
Phase III trial of SOTORASIB for Non-small cell lung cancer (KRAS p.G12C-mutated).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (KRAS p.G12C-mutated)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-11-2023
- First CTIS Authorization Date
- 05-02-2024
Trial design
Randomised, open-label, control treatment group: docetaxel (comparator). investigational treatment group: amg 510 (sotorasib). dose/schedule not specified in the available ctis part i summary. Phase III trial across 33 sites in Netherlands, Sweden, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control Treatment Group: Docetaxel (comparator). Investigational Treatment Group: AMG 510 (sotorasib). Dose/schedule not specified in the available CTIS Part I summary.
- Biomarker Stratified
- True, biomarker: KRAS p.G12C mutation
- Target Sample Size
- 209
Eligibility
Recruits 209 Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent is obtained using Subject Information and Informed Consent Forms (multiple L1_SIS and ICF documents for adults are listed in the CTIS documents). Minimum age for participation is ≥18 years. No assent or parental consent procedures are described in the available CTIS data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent is obtained using Subject Information and Informed Consent Forms (multiple L1_SIS and ICF documents for adults are listed in the CTIS documents). Minimum age for participation is ≥18 years. No assent or parental consent procedures are described in the available CTIS data.
Inclusion criteria
- {"criterion_text":"- Men or women greater than or equal to 18 years old."}
- {"criterion_text":"- ECOG ≤ 1"}
- {"criterion_text":"- Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment"}
Exclusion criteria
- {"criterion_text":"- Active brain metastases"}
- {"criterion_text":"- Myocardial infarction within 6 months of study day 1"}
- {"criterion_text":"- Gastrointestinal (GI) tract disease causing the inability to take oral medication"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS - defined as time from randomization until disease progression or death from any cause, whichever occurs first for all subjects. Progression will be based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).","definition_or_measurement_approach":"PFS defined as time from randomization until disease progression or death from any cause; progression assessed by blinded independent central review (BICR) per RECIST v1.1."}
Secondary endpoints
- {"endpoint_text":"- Overall survival - defined as time from randomization until death from any cause.","definition_or_measurement_approach":"Overall survival defined as time from randomization until death from any cause."}
- {"endpoint_text":"- Objective response (complete response [CR] + partial response [PR]), assessed per RECIST v1.1. Response will be assessed by BICR. Complete response and PR require confirmatory repeat radiologic assessment at no less than 4 weeks after the original response. The normal subsequent assessment is acceptable to confirm response.","definition_or_measurement_approach":"Objective response assessed per RECIST v1.1 by Blinded Independent Central Review (BICR); CR and PR require confirmatory radiologic assessment at least 4 weeks after initial response."}
- {"endpoint_text":"- Change from baseline (cycle 1 day 1) over time to week 12 in disease related symptoms of: - Dyspnea as measured by a 4-item dyspnea domain from QLQ-C30 and QLQ-LC13 - Cough as measured by QLQ-LC13 - Chest Pain as measured by QLQ-LC13","definition_or_measurement_approach":"Change from baseline (cycle 1 day 1) to week 12 in disease-related symptoms measured by EORTC QLQ-C30 and QLQ-LC13 instruments (specific domains: dyspnea domain (4 items), cough, chest pain)."}
- {"endpoint_text":"- Change from baseline over time to week 12 in: - Physical functioning as measured by QLQ-C30 - Global health status as measured by QLQ-C30","definition_or_measurement_approach":"Change from baseline to week 12 in physical functioning and global health status as measured by EORTC QLQ-C30."}
Recruitment
- Planned Sample Size
- 209
- Recruitment Window Months
- 83
- Consent Approach
- Informed consent obtained from adult participants using Subject Information Sheets and Informed Consent Forms (multiple L1_SIS and ICF documents are listed). Country-specific and language-specific ICF versions are available for participating countries (documents in country-specific sets for France, Germany, Spain, Italy, Poland, Sweden, Netherlands, Greece are present). Minimum participant age is 18; no assent or parental consent procedures are described in the available documentation.
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 362
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 20-09-2024
- Processing Time Days
- 304
- Number Of Sites
- 4
- Number Of Participants
- 74
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Pulmonary Diseases
- Principal Investigator Name
- Anthonie van der Wekken
- Principal Investigator Email
- a.j.van.der.wekken@umcg.nl
- Contact Person Name
- Anthonie van der Wekken
- Contact Person Email
- a.j.van.der.wekken@umcg.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medical Oncology
- Principal Investigator Name
- Joop de Langen
- Principal Investigator Email
- j.d.langen@nki.nl
- Contact Person Name
- Joop de Langen
- Contact Person Email
- j.d.langen@nki.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pulmonology
- Principal Investigator Name
- Anne-Marie Dingemans
- Principal Investigator Email
- a.dingemans@erasmusmc.nl
- Contact Person Name
- Anne-Marie Dingemans
- Contact Person Email
- a.dingemans@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Medical Oncology
- Principal Investigator Name
- Evelien van der Hout
- Principal Investigator Email
- e.c.vanderhout@umcutrecht.nl
- Contact Person Name
- Evelien van der Hout
- Contact Person Email
- e.c.vanderhout@umcutrecht.nl
Sweden
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 15-08-2024
- Processing Time Days
- 268
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Sahlgrenska University Hospital-Vastra Gotalandsregionen
- Department Name
- Oncology
- Principal Investigator Name
- Jan Nyman
- Principal Investigator Email
- jan.nyman@vgregion.se
- Contact Person Name
- Jan Nyman
- Contact Person Email
- jan.nyman@vgregion.se
Poland
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 21-01-2025
- Processing Time Days
- 427
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Oncology
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- zspecht@uck.gda.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- zspecht@uck.gda.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 07-01-2025
- Processing Time Days
- 413
- Number Of Sites
- 3
- Number Of Participants
- 54
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Margarita Majem Tarruella
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Institut Catala D'oncologia
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Ernest Nadal Alforja
- Principal Investigator Email
- esnadal@iconcologia.net
- Contact Person Name
- Ernest Nadal Alforja
- Contact Person Email
- esnadal@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Pilar Garrido López
- Principal Investigator Email
- pilargarridol@gmail.com
- Contact Person Name
- Pilar Garrido López
- Contact Person Email
- pilargarridol@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 561
- Number Of Sites
- 7
- Number Of Participants
- 57
Sites
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Klinik fuer Haematologie und Onkologie
- Principal Investigator Name
- Frank Griesinger
- Principal Investigator Email
- Frank.Griesinger@pius-hospital.de
- Contact Person Name
- Frank Griesinger
- Contact Person Email
- Frank.Griesinger@pius-hospital.de
- Site Name
- POIS Sachsen GmbH
- Department Name
- POIS Sachsen GmbH iG
- Principal Investigator Name
- Juliana Brode
- Principal Investigator Email
- j.brode@pois-sachsen.de
- Contact Person Name
- Juliana Brode
- Contact Person Email
- j.brode@pois-sachsen.de
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Klinik fuer Kardiologie Angiologie und Pneumologie
- Principal Investigator Name
- Martin Faehling
- Principal Investigator Email
- M.Faehling@klinikum-esslingen.de
- Contact Person Name
- Martin Faehling
- Contact Person Email
- M.Faehling@klinikum-esslingen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik I fur Innere Medizin
- Principal Investigator Name
- Juergen Wolf
- Principal Investigator Email
- juergen.wolf@uk-koeln.de
- Contact Person Name
- Juergen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
- Site Name
- Asklepios Fachkliniken Muenchen Gauting
- Department Name
- Thorakale Onkologie
- Principal Investigator Name
- Niels Reinmuth
- Principal Investigator Email
- n.reinmuth@asklepios.com
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- n.reinmuth@asklepios.com
- Site Name
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
- Department Name
- Studienzentrum
- Principal Investigator Name
- Christian Grohe
- Principal Investigator Email
- christian.grohe@jsd.de
- Contact Person Name
- Christian Grohe
- Contact Person Email
- christian.grohe@jsd.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Thoraxonkologie
- Principal Investigator Name
- Farastuk Bozorgmehr
- Principal Investigator Email
- farastuk.bozorgmehr@med.uni-heidelberg.de
- Contact Person Name
- Farastuk Bozorgmehr
- Contact Person Email
- farastuk.bozorgmehr@med.uni-heidelberg.de
Greece
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 561
- Number Of Sites
- 5
- Number Of Participants
- 38
Sites
- Site Name
- General University Hospital Of Patras
- Department Name
- Division of Oncology, Department of Medicine
- Principal Investigator Name
- Angelos Koutras
- Principal Investigator Email
- angkoutr@otenet.gr
- Contact Person Name
- Angelos Koutras
- Contact Person Email
- angkoutr@otenet.gr
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Department of Oncology
- Principal Investigator Name
- Ioannis Mountzios
- Principal Investigator Email
- gmountzios@gmail.com
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- Metropolitan Hospital
- Department Name
- 4th Oncology dept
- Principal Investigator Name
- Helena Linardou
- Principal Investigator Email
- elinardou@otenet.gr
- Contact Person Name
- Helena Linardou
- Contact Person Email
- elinardou@otenet.gr
- Site Name
- Theageneio Cancer Hospital
- Department Name
- 1st Department of Clinical Oncology
- Principal Investigator Name
- Pavlos Papakotoulas
- Principal Investigator Email
- papakotoulas@gmail.com
- Contact Person Name
- Pavlos Papakotoulas
- Contact Person Email
- papakotoulas@gmail.com
- Site Name
- St. Luke's Hospital S.A.
- Department Name
- Oncology Department
- Principal Investigator Name
- Ippokratis Korantzis
- Principal Investigator Email
- ippokratis.korantzis@gmail.com
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 561
- Number Of Sites
- 9
- Number Of Participants
- 70
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Service de Pneumologie et Oncologie Thoracique
- Principal Investigator Name
- Maurice Perol
- Principal Investigator Email
- maurice.perol@lyon.unicancer.fr
- Contact Person Name
- Maurice Perol
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- Departement Oncologie Médicale
- Principal Investigator Name
- Nicolas Girard
- Principal Investigator Email
- nicolas.girard2@curie.fr
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curie.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Service de pneumologie
- Principal Investigator Name
- Sebastien Couraud
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sebastien Couraud
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Hopital Tenon
- Department Name
- Service de pneumologie
- 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
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Herve Lena
- Principal Investigator Email
- herve.lena@chu-rennes.fr
- Contact Person Name
- Herve Lena
- Contact Person Email
- herve.lena@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service oncologie médicale thoracique et digestive
- Principal Investigator Name
- Stéphanie Bordenave-Caffre
- Principal Investigator Email
- stephanie.bordenave@chu-nantes.fr
- Contact Person Name
- Stéphanie Bordenave-Caffre
- Contact Person Email
- stephanie.bordenave@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service Pneumologie
- Principal Investigator Name
- Julien Mazieres
- Principal Investigator Email
- mazieres.julien@gmail.com
- Contact Person Name
- Julien Mazieres
- Contact Person Email
- mazieres.julien@gmail.com
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Service Oncologie Medicale
- Principal Investigator Name
- Alain Vergnenegre
- Principal Investigator Email
- Alain.Vergnenegre@chu-limoges.fr
- Contact Person Name
- Alain Vergnenegre
- Contact Person Email
- Alain.Vergnenegre@chu-limoges.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- Service Oncologie
- Principal Investigator Name
- Pascale Tomasini
- Principal Investigator Email
- pascale.tomasini@ap-hm.fr
- Contact Person Name
- Pascale Tomasini
- Contact Person Email
- pascale.tomasini@ap-hm.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 561
- Number Of Sites
- 3
- Number Of Participants
- 54
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alessandra Bulotta
- Principal Investigator Email
- bulotta.alessandra@hsr.it
- Contact Person Name
- Alessandra Bulotta
- Contact Person Email
- bulotta.alessandra@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Oncology
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hector Josè Soto Parra
- Principal Investigator Email
- hsotoparra.ctu@gmail.com
- Contact Person Name
- Hector Josè Soto Parra
- Contact Person Email
- hsotoparra.ctu@gmail.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
- CRO services (sponsorDuties code: 1)
- Name
- Medidata Solutions Inc.
- Responsibilities
- Clinical data / eClinical services (sponsorDuties code: 7)
- Name
- Iqvia Rds Inc.
- Responsibilities
- CRO services (sponsorDuties codes: 1, 6)
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- Clinical technology services (sponsorDuties code: 3)
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"sponsorDuties codes: [1] (listed as code '1')","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Tempus Labs Inc.","duties_or_roles":"Exploratory Biomarker; sponsorDuties codes: [15, 4]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: [1, 6]","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A. (Anapafseos address)","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Storage and shipping of blood and tissues; sponsorDuties codes: [15, 4]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Genetic testing of subjects tissue samples; sponsorDuties codes: [15, 4]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Resolution Bioscience Inc.","duties_or_roles":"ctDNA plasma DNA extraction ad analysis; sponsorDuties codes: [15, 4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Rad Md LLC","duties_or_roles":"Independent Imaging Review; sponsorDuties codes: [15]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"ePRO device programming and provisioning; capturing and reporting PRO data; sponsorDuties codes: [15]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long Term Storage; sponsorDuties codes: [15, 4]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SOTORASIB
- Active Substance
- SOTORASIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 960 mg (maxDailyDoseAmount from product metadata)
- Investigational Product Name
- DOCETAXEL
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Maximum Dose
- 75 mg/m2 (maxDailyDoseAmount from product metadata)
- Investigational Product Name
- Dexamethasone 2mg Tablets
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation PL 29831/0678 listed in product metadata)
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