Lung Cancer Clinical Trial

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

Summary

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Measurable disease
Adequate recovery from most recent systemic or local treatment for cancer
Adequate organ function
Life expectancy greater than or equal to (>/=) 12 weeks
For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception

Exclusion Criteria:

Inability to swallow oral medication
Women who are pregnant or lactating
Symptomatic, untreated CNS metastases
History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
Known human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome (AIDS)-related illness
Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
Inability to comply with other requirements of the protocol

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

1000

Study ID:

NCT03178552

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 179 Locations for this study

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University of California San Diego
La Jolla California, 92093, United States
UC Davis; Comprehensive Cancer Center
Sacramento California, 95817, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich Connecticut, 06360, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Florida Cancer Specialist, North Region
Saint Petersburg Florida, 33705, United States
University Cancer & Blood Center, LLC; Research
Athens Georgia, 30607, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
University of Kentucky; Markey Cancer Center
Lexington Kentucky, 40536, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Henry Ford Health System; Hematology/Oncology
Detroit Michigan, 48202, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cancer Inst. of New Jersey
New Brunswick New Jersey, 08901, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York New York, 10021, United States
Ohio State University
Columbus Ohio, 43212, United States
Oregon HSU
Portland Oregon, 97210, United States
St. Luke's University Health network
Bethlehem Pennsylvania, 18015, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville Tennessee, 37203, United States
Texas Oncology - South Austin
Austin Texas, 78745, United States
Oncology Consultants PA
Houston Texas, 77030, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
University of Washington Seattle Cancer Care Alliance
Seattle Washington, 98195, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Hospital Italiano
Buenos Aires , C1181, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires , C1284, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja , F5300, Argentina
Royal North Shore Hospital; Department of Medical Oncology
St Leonards New South Wales, 2065, Australia
The Prince Charles Hospital; Oncology Dept.
Chermside Queensland, 4032, Australia
Ashford Cancer Center Research
Kurralta Park South Australia, 5037, Australia
Austin Hospital; Medical Oncology
Heidelberg Victoria, 3084, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
UZ Brussel
Brussel , 1090, Belgium
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro RJ, 20560, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijui RS, 98700, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
CancerCare Manitoba; Department of Medical Oncology
Winnipeg Manitoba, R3E 0, Canada
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie Ontario, L4M 6, Canada
William Osler Health System Brampton Civic Hospital
Brampton Ontario, L6R 3, Canada
London Health Sciences Centre · Victoria Hospital; Department of Medicine
London Ontario, N6A 5, Canada
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center
Oshawa Ontario, L1G 2, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
IUCPQ (Hôpital Laval)
Quebec City Quebec, G1V 4, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, SK S7, Canada
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
Recoleta , 84203, Chile
Jilin Cancer Hospital
Changchun , 13201, China
The Second Affiliated Hospital to Nanchang University
Nanchang , 33000, China
Clinica CIMCA
San José , 10103, Costa Rica
Institut Bergonie CLCC Bordeaux
Bordeaux , 33000, France
Centre Francois Baclesse; Radiologie
Caen , 14076, France
Centre Oscar Lambret
Lille , 59020, France
Centre Léon Bérard
Lyon , 69373, France
Hopital Caremeau; Pneumologie
Nimes , 30029, France
Hopital Bichat Claude Bernard; Oncologie Serv.
Paris , 75018, France
Hôpital Européen Georges Pompidou
Paris , 75908, France
Hopital Tenon;Pneumologie
Paris , 75970, France
CHU Poitiers
Poitiers , 86021, France
Hopital Pontchaillou
Rennes , 35033, France
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
Toulouse cedex 9 , 31100, France
Hopital Bretonneau; Pneumologie Oncologie
Tours , 37044, France
Hopital Robert Schuman; Pneumologie
Vantoux , 57070, France
Klinikum Chemnitz gGmbH
Chemnitz , 09116, Germany
Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf , 40225, Germany
Universitätsklinikum Essen; Innere Klinik (Tumorforschung)
Essen , 45147, Germany
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen , 73730, Germany
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
Gauting , 82131, Germany
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
Gerlingen , 70839, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
Wiesbaden , 65199, Germany
Pamela Youde Nethersole Eastern Hospital
Hong Kong , Chai , Hong Kong
Queen Mary Hospital; Medicine & Respiratory
Hong Kong , , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin , , Hong Kong
Soroka Medical Center; Oncology Dept
Beer Sheva , 84101, Israel
Rambam Health Care Campus; Oncology
Haifa , 31096, Israel
Meir Medical Center; Oncology
Kfar-Saba , 44281, Israel
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva , 49414, Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan , 52621, Israel
Sourasky / Ichilov Hospital; Dept. of Oncology
Tel Aviv , 64239, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano Friuli-Venezia Giulia, 33081, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma Lazio, 151, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo Lombardia, 24127, Italy
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
Cremona Lombardia, 26100, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
Milano Lombardia, 20141, Italy
Asst Di Monza
Monza Lombardia, 20900, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica
Orbassano (TO) Piemonte, 10043, Italy
Fujita Health University Hospital
Aichi , 470-1, Japan
National Cancer Center Hospital East
Chiba , 277-8, Japan
Shikoku Cancer Center
Ehime , 791-0, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka , 810-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Hiroshima University Hospital
Hiroshima , 734-8, Japan
Kanazawa University Hospital
Ishikawa , 920-8, Japan
Kanagawa Cancer Center
Kanagawa , 241-8, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto , 602-8, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
Sendai Kousei Hospital
Miyagi , 980-0, Japan
Tohoku University Hospital
Miyagi , 980-8, Japan
Niigata University Medical & Dental Hospital
Niigata , 951-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Kindai University Hospital
Osaka , 589-8, Japan
Saga University Hospital
Saga , 849-8, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
Juntendo University Hospital
Tokyo , 113-8, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo , 113-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Kyorin University Hospital
Tokyo , 181-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
National Hospital Organization Yamaguchi - Ube Medical Center
Yamaguchi , 755-0, Japan
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Yonsei University Health System/Severance Hospital
Seoul , 120-7, Korea, Republic of
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Oncologico Potosino
San Luis Potosí SAN LUIS Potosi, 78209, Mexico
AVIX Investigación Clínica S.C
Monterrey , 64710, Mexico
Hospital Angeles Tijuana
Tijuana , 22010, Mexico
UMCG
NL -groningen , 9700 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
Auckland City Hospital
Auckland , 1023, New Zealand
Hemato Oncología de Panamá Especializada
Panama City , 0801, Panama
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
Lima , 11, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima , Lima , Peru
Clinica Ricardo Palma
San Isidro , Lima , Peru
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk , 80-21, Poland
Krakowski Szpital Specjalistyczny im.Jana Pawla II
Krakow , 31-20, Poland
Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock , 05-40, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan , 60-56, Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
Warszawa , 02-78, Poland
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow Moskovskaja Oblast, 10522, Russian Federation
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow , 11547, Russian Federation
Clinical Oncology Dispensary; Chemotherapy
Omsk , 64401, Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint-Petersburg , 19775, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary
St Petersburg , 19702, Russian Federation
Clinical Center of Serbia
Belgrade , 11000, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade , 11080, Serbia
Clinical Center Nis
NIS , 18000, Serbia
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica , 21204, Serbia
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore , 11922, Singapore
National Cancer Centre; Medical Oncology
Singapore , 16961, Singapore
Insititut Catala D'Oncologia
Hospitalet de Llobregat Barcelona, 08908, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela LA Coruña, 15706, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda Madrid, 28222, Spain
Hospital Quiron de Madrid; Servicio de Oncologia
Pozuelo de Alarcon Madrid, 28223, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital General Univ. de Alicante
Alicante , 03010, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona , 08036, Spain
ICO Badalona - Hospital Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Centro Integral Oncologico Clara Campal; Servicio de Oncología
Madrid , 28050, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga , 29011, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia , 46010, Spain
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung , 83301, Taiwan
National Taiwan Uni Hospital; Internal Medicine
Taipei , 100, Taiwan
Taipei Medical University Hospital
Taipei , 110, Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei , 112, Taiwan
Chang Gung Medical Foundation - Linkou; Chest Dept
Taoyuan , 333, Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok , 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok , 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok , 10700, Thailand
Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine
Hat Yai , 90110, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana , 01230, Turkey
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya , 07070, Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne , 22770, Turkey
Medipol University MF; Oncology Department
Istanbul , 34214, Turkey
Pendik Training and Research Hospital; Medical Oncology
Istanbul , 34890, Turkey
Medikal Park Izmir Hospital
Karşıyaka , 35575, Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara , 06230, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

1000

Study ID:

NCT03178552

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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