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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04685135
Other study ID # CA239-0013
Secondary ID CA239-0013849-01
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2021
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source Mirati Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 453
Est. completion date December 31, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. - Candidacy to receive treatment with docetaxel. Crossover Inclusion Criteria: - Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR - ECOG performance status 0-2 Exclusion Criteria: - Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib). - Active brain metastases. Crossover Exclusion Criteria: - Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MRTX849
21 day cycles
Docetaxel
21 day cycles

Locations

Country Name City State
Australia Flinders Medical Centre Bedford Park
Australia Monash Health Clayton
Australia Townsville University Hospital Douglas
Australia GenesisCare - North Shore St. Leonards
Australia The Tweed Hospital Tweed Heads
Australia Cancer Care Wollongong Wollongong
Australia Princess Alexandra Hospital Woolloongabba
Austria Klinikum Klagenfurt Am Worthersee Klagenfurt Am Woerthersee
Austria Uniklinikum Salzburg Salzburg
Austria Wiener Gesundheitsverbund - Klinik Ottakring Wien
Belgium Universitair Ziekenhuis Brussel Brussel
Belgium Grand Hopital de Charleroi - Notre Dame Charleroi
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Algemeen Ziekenhuis Maria Middelares Gent
Belgium Jessa Ziekenhuis - Campus Virga Jesse Hasselt
Belgium Algemeen Ziekenhuis Delta - Campus Rumbeke Roeselare
Belgium Algemeen Ziekenhuis Glorieux Ronse Ronse
Belgium Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne Yvoir
Czechia Multiscan - Ambulance klinicke onkologie se stacionarem - Horovice Horovice
Czechia Fakultni Nemocnice Olomouc Olomouc
Czechia Fakultni nemocnice Bulovka Praha 8 - Liben
France Hopital Morvan Brest
France Hopital Louis Pradel Bron
France Centre Hospitalier Universitaire de Caen Normandie Caen Cedex 09
France Centre Francois Baclesse Caen Cedex 5
France Centre Hospitalier Intercommunal de Creteil Creteil
France Centre Georges Francois Leclerc Dijon cedex
France LHopital Nord-Ouest (HNO) - Villefranche-sur-Saone Gleize
France Hopital Michallon La Tronche
France Centre Hospitalier Regional Universitaire de Lille Lille Cedex
France Centre Hospitalier Universitaire Dupuytren 1 Limoges cedex
France Hopital Nord de Marseille Marseille
France Institut Paoli-Calmettes Marseille
France Hopital Arnaud de Villeneuve Montpellier
France Hopital Emile Muller Mulhouse
France Centre Antoine Lacassagne Nice Cedex 2
France Centre Hospitalier de Cornouaille - Hopital Laennec Quimper
France Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau Saint Herblain
France Institut de Cancerologie Strasbourg Europe Strasbourg
France Hopital Civil Strasbourg cedex
France Hopital Bretonneau Tours Cedex 9
France Gustave Roussy Villejuif
Germany Zentralklinik Bad Berka Bad Berka
Germany Universitatsklinikum Bonn Bonn
Germany Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung Essen
Germany Asklepios Fachkliniken Munchen-Gauting Gauting
Germany Universitatsklinikum Gieen und Marburg - Gieen Giessen
Germany LungenClinic Grosshansdorf Grohansdorf
Germany Krankenhaus Martha-Maria Halle-Dolau Halle
Germany Universitatsklinikum Jena Jena
Germany Klinikum Kassel Kassel
Germany Klinikum Koln-Merheim Koln
Germany SLK-Kliniken - Fachklinik Lowenstein Lowenstein
Germany Universitatsklinikum Schleswig-Holstein - Campus Lubeck Lubeck
Germany Munchen Klinik Bogenhausen Munchen
Germany Sana Klinikum Offenbach Offenbach
Germany Pius-Hospital Oldenburg Oldenburg
Greece General Hospital for Thoracic Diseases Sotiria Athens
Greece Henry Dunant Hospital Center Athens
Greece University General Hospital of Heraklion (PAGNI) Heraklion
Greece University General Hospital of Larissa Larissa
Greece "General Oncology Hospital of Kifisias "Agioi Anargyroi"" Nea Kifisia
Greece Metropolitan Hospital Peiraias
Greece BioClinic Thessaloniki Thessaloniki
Greece General Hospital of Thessaloniki George Papanikolaou Thessaloniki
Greece Interbalkan Medical Center of Thessaloniki Thessaloniki
Greece Anassa General Clinic Volos
Hong Kong Humanity & Health Clinical Trial Centre Central
Hong Kong Prince of Wales Hospital - Hong Kong Hong Kong
Hong Kong Hong Kong United Oncology Centre Kowloon
Hungary Orszagos Koranyi Pulmonologiai Intezet Budapest
Hungary Orszagos Onkologiai Intezet Budapest
Hungary Semmelweis Egyetem - Pulmonologiai Klinika Budapest
Hungary Matrai Gyogyintezet Gyongyos
Hungary Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaz Gyula
Hungary Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar
Hungary Reformatus Pulmonologiai Centrum Torokbalint
Ireland Beaumont Hospital - Dublin Dublin
Ireland St. Jamess Hospital Dublin
Ireland St. Vincents University Hospital Dublin
Ireland University Hospital Galway Galway
Ireland University Hospital Limerick Limerick
Ireland The Meath Foundation Tallaght Dublin
Italy Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria Alessandria
Italy Azienda Ospedaliera San Giuseppe Moscati - Avellino Avellino
Italy Centro di Riferimento Oncologico Aviano
Italy Istituto Tumori Bari Giovanni Paolo II - IRCCS Bari
Italy Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia Brescia
Italy Istituto di Candiolo - Fondazione del Piemonte per lOncologia Candiolo
Italy Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi Catania
Italy Azienda Ospedaliero - Universitaria - Policlinico - Vittorio Emanuele Catania
Italy Azienda Ospedaliero - Universitaria Careggi Firenze
Italy ASL 3 Genovese - Ospedale Villa Scassi - Sampierdarena Genova
Italy Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino Genova
Italy Ospedale Vito Fazzi Lecce Lecce
Italy "Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST" Meldola
Italy Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Milan
Italy Istituto Europeo di Oncologia Milan
Italy Fondazione IRCCS - Istituto Nazionale dei Tumori Milano
Italy Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Napoli
Italy Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli
Italy Azienda Ospedaliero-Universitaria Maggiore della Carita di Novara Novara
Italy Azienda Ospedaliero-Universitaria di Parma Parma
Italy Azienda Ospedaliera di Perugia - Santa Maria della Misericordia Perugia
Italy Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro
Italy Ospedale Santa Maria delle Croci di Ravenna Ravenna
Italy Azienda Ospedaliera Universitaria Integrata Verona Verona
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Kosin University Gospel Hospital Busan
Korea, Republic of Pusan National University Hospital Busan-si
Korea, Republic of Chungbuk National University Hospital Cheongju-si
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Inha University Hospital Jung-Gu
Korea, Republic of Cha Bundang Medical Center Seongnam-si
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Severance Hospital - Yonsei Cancer Center Seoul
Korea, Republic of The Catholic University of Korea - Seoul St. Marys Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon-si
Korea, Republic of Catholic University of Korea Saint Vincents Hospital Suwon-Si
Netherlands Amsterdam Universitair Medische Centra (UMC) - Locatie Vrije Universiteit Medisch Centrum Amsterdam
Netherlands Hagaziekenhuis Van Den Haag - Leyweg Den Haag
Netherlands Maastricht Universitair Medisch Centrum Maastricht
Netherlands Radboud Universitair Medisch Centrum Nijmegen
Netherlands St. Antonius Ziekenhuis - Ziekenhuis Utrecht Utrecht
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Poland Instytut MSF Lodz
Poland MS Pnuemed - Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna Lublin
Poland Specjalistyczna Praktyka Lekarska Slawomir Mandziuk Lublin
Poland Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy Otwock
Poland Mruk-Med I Sp. z o.o. Rzeszow
Poland Pratia Poznan Skorzewo
Poland Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Torun
Poland Wojskowy Instytut Medyczny Warsaw
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa
Portugal Unidade Local de Saude de Almada-Seixal, E. P. E (Hospital Garcia de Orta) Almada
Portugal Unidade Local de Saude de Braga, E. P. E (Hospital de Braga) Braga
Portugal Instituto Portugues de Oncologia de Coimbra Francisco Gentil Coimbra
Portugal Unidade Local de Saude de Coimbra Coimbra
Portugal Unidade Local de Saude do Alto Ave, E. P. E (Hospital da Senhora da Oliveira Guimaraes) Guimaraes
Portugal Hospital CUF Descobertas Lisbon
Portugal Instituto Portugues De Oncologia De Lisboa Francisco Gentil Lisbon
Portugal The Champalimaud Centre for the Unknown Lisbon
Portugal Unidade Local de Saude de Loures-Odivelas, EPE (Hospital Beatriz Angelo) Loures
Portugal Hospital CUF Porto Porto
Portugal Instituto Portugues de Oncologia do Porto Francisco Gentil Porto
Portugal Unidade Local de Saude de Santo Antonio, E. P. E - Hospital Geral de Santo Antonio Porto
Portugal Unidade Local de Saude de Entre Douro e Vouga, E. P. E Santa Maria Da Feira
Portugal Unidade Local de Saude da Arrabida, E. P. E (Centro Hospitalar de Setubal) Setubal
Portugal Unidade Local de Saude de Gaia/Espinho, E. P. E Vila Nova de Gaia
Puerto Rico Fundacion de Investigacion de Diego Clinical Research San Juan
Puerto Rico PanOncology Trials - Rio Piedras Medical Center San Juan
Puerto Rico Puerto Rico Medical Research Center San Juan
Romania Spitalul Jude?ean de Urgen?a dr. Constantin Opri? Baia Mare Baia Mare
Romania SC Policlinica de Diagnostic Rapid SA Bra?ov
Romania Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu Bucharest
Romania Centrul Oncologic Sanador Bucure?ti
Romania Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Romania Medisprof Cluj-Napoca
Romania Centrul de Oncologie Sf Nectarie Craiova
Romania Oncolab Craiova Craiova
Romania Centrul de Oncologie Euroclinic Iasi
Romania Ovidius Clinical Hospital Ovidiu
Romania Oncocenter - Oncologie Clinica Timi?oara
Romania SC OncoMed SRL Timisoara
Russian Federation Evimed Oncology Clinic Chelyabinsk
Russian Federation "Budgetary Healthcare Institution of the Udmurt Republic "Republican Clinical Oncological Dispensary n.a. Sergey Grigoryevich Pr Izhevsk
Russian Federation "Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical Center" of the Healthcare C Kislino Village
Russian Federation University Headache Clinic Moscow
Russian Federation VitaMed - Moscow Moscow
Russian Federation State Budgetary Healthcare Institution of the Nizhny Novgorod Region Clinical Diagnostic Center Nizhniy Novgorod
Russian Federation "Limited Liability Company Medical Sanitary Unit "Clinicist-Clinic Pretor"" Novosibirsk
Russian Federation "Budgetary Healthcare Institution of Omsk region "Clinical Oncologic Dispensary"" Omsk
Russian Federation EuroCityClinic LLC Saint Petersburg
Russian Federation Saint Petersburg Clinical Scientific & Practical Center for Specialized Types of Medical Care (Oncology) Saint Petersburg
Russian Federation "Federal State Budgetary Institution "Influenza Research Institute named after N.N. A.A. Smorodintsev" of the Ministry of Health Saint-Petersburg
Singapore Icon Cancer Centre Farrer Park Singapore
Singapore National Cancer Centre Singapore Singapore
Singapore Oncocare Cancer Centre Singapore
Singapore Parkway Cancer Centre - Gleneagles Hospital Singapore
Singapore Raffles Hospital Singapore
Spain Complejo Hospitalario Universitario A Coruna A Coruna
Spain Hospital General Universitario Dr. Balmis Alicante
Spain Hospital Germans Trias i Pujol Badalona
Spain Hospital Universitario Cruces Barakaldo
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital del Mar - Parc de Salut Mar Barcelona
Spain Hospital Universitari Dexeus Barcelona
Spain Hospital Universitari Vall dHebron Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Institut Catala dOncologia Girona (ICO Girona) Girona
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas de Gran Canaria
Spain Hospital de Leon Leon
Spain Hospital Universitario Lucus Augusti Lugo
Spain Clinica Universidad de Navarra - Madrid Madrid
Spain Hospital Beata Maria Ana Madrid
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda
Spain Hospital Regional Universitario de Malaga - Hospital Civil Malaga
Spain Hospital Universitario Son Espases Palma de Mallorca
Spain Hospital Universitario Marques de Valdecilla Santander
Spain Consorci Hospital General Universitari de Valencia Valencia
Spain Hospital Universitari i Politecnic La Fe Valencia
Spain Hospital Clinico Universitario Lozano Blesa Zaragoza
Switzerland Universitatsspital Basel Basel
Switzerland Kantonsspital Winterthur Winterthur
United Kingdom University Hospital Birmingham NHS Foundation Trust Birmingham
United Kingdom NHS Lothian Edinburgh
United Kingdom NHS Greater Glasgow and Clyde Glasgow
United Kingdom University Hospitals of Leicester NHS Trust Leicester
United Kingdom The Christie NHS Foundation Trust Manchester
United States Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North Arlington Texas
United States University Cancer & Blood Center (UCBC) - Athens Athens Georgia
United States Texas Oncology - South Austin Austin Texas
United States Sisters of Charity of Leavenworth Health St. Marys Billings Montana
United States St. Vincent Healthcare Cancer Centers of Montana Billings Montana
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States TOI Clinical Research (ICIR) Cerritos California
United States UVA Health - University Hospital Charlottesville Virginia
United States University of Chicago Chicago Illinois
United States University of Illinois Hospital & Health Sciences System Chicago Illinois
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States City of Hope - Duarte (Main Campus) Duarte California
United States Astera Cancer Care - East Brunswick East Brunswick New Jersey
United States NEXT Virginia Fairfax Virginia
United States Holy Cross Health Fort Lauderdale - Holy Cross Hospital Fort Lauderdale Florida
United States Frederick Health Frederick Maryland
United States Goshen Center for Cancer Care Goshen Indiana
United States Prisma Health Cancer Institute - Faris Road Greenville South Carolina
United States Franciscan Health Cancer Center Indianapolis Indianapolis Indiana
United States Local Institution - 012-999 Irving Texas
United States 21st Century Oncology of Jacksonville - North Lee Street Jacksonville Florida
United States Cancer Specialists of North Florida - Southpoint Jacksonville Florida
United States Kettering Health Cancer Center - Main Campus Kettering Ohio
United States SCL Health - Saint Joseph Hospital Cancer Center Lafayette Colorado
United States Baptist Health Lexington Lexington Kentucky
United States Rocky Mountain Cancer Centers - Lone Tree Lone Tree Colorado
United States Northwest Georgia Oncology Centers Wellstar - Marietta Marietta Georgia
United States Franciscan Health Munster Munster Indiana
United States Tulane University New Orleans Louisiana
United States Illinois Cancer Specialists - Niles Niles Illinois
United States Orlando Health University of Florida Health Cancer Center - Head and Neck Center Orlando Florida
United States USOR - Woodlands Medical Specialists Pensacola Florida
United States Lifespan Cancer Institute - Rhode Island Hospital Providence Rhode Island
United States Oregon Oncology Specialists Salem Oregon
United States Utah Cancer Specialists - UCS Cancer Center Salt Lake City Utah
United States Providence Medical Group - Santa Rosa Santa Rosa California
United States New England Cancer Specialists - Scarborough Scarborough Maine
United States Texas Oncology - Sherman Sherman Texas
United States Avera Cancer Institute Sioux Falls South Dakota
United States Ascension Providence Cancer Center - Southfield Southfield Michigan
United States SUNY Upstate Medical University Syracuse New York
United States Holy Name Medical Center Teaneck New Jersey
United States University of Kansas Medical Center Westwood Kansas
United States Cancer Center of Kansas - Wichita - Heritage Plaza Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first. 32 Months
Secondary Overall Survival (OS) Defined as time from date of randomization to date of death due to any cause. 49 Months
Secondary Objective Response Rate (ORR) Defined as the percent of patients documented to have a confirmed CR or PR. 32 Months
Secondary Duration of Response (DOR) Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first. 49 Months
Secondary 1-year Survival Rate 49 Months
Secondary Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event. 49 Months
Secondary Population PK parameters of MRTX849 Data for this Outcome Measure will not be reported here but will be used in a Population PK Analysis which will include participants who were not enrolled in this study, and issued in a separate report. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules 49 Months
Secondary Patient Reported Outcomes (PROs) To be assessed by Lung Cancer Symptom Scale (LCSS). 49 Months
Secondary Quality of LIfe Assessment To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L). 49 Months
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