A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer

Who is this study for? Patients with locally advanced, unresectable, stage III non-small cell lung cancer
Status: Recruiting
Location: See all (180) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Body weight \>/= 30 kg at screening

• Willingness and ability to use the electronic device(s) or application(s) for the electronic patient-reported outcome (PRO)

• Whole-body positron emission tomography/computed tomography scan (PET/CT) (from the base of skull to mid-thighs) for the purposes of staging, performed prior and within 42 days for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) of the first dose of cCRT or sCRT

• Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology

• Prior receipt of at least two prior cycles of platinum-based chemotherapy given concurrently with radiotherapy (cCRT); or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy (sCRT)

• The RT component in the cCRT or sCRT must have been at a total dose of radiation of 60 (+/-10%) Gy (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy (preferred) or three dimension (3D)-conforming technique

• No disease progression during or following platinum-based cCRT or sCRT

• Life expectancy \>/= 12 weeks

• Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen

• Tumor PD-L1 status (TC score \< 1% vs. \>/= 1% vs. unknown) as determined using the VENTANA PD-L1 IHC SP263 assay (preferred) or the Dako PD-L1 IHC 22C3 pharmDx assay

• Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2

• Adequate hematologic and end-organ function

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined by the protocol

• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm, as defined by the protocol

• Documented ALK fusion positivity by an eligible result from: centralized multiplex molecular testing of tumor tissue at the Sponsor's designated central laboratory under Study BX43361 or prior tissue-based testing performed in an accredited or certified laboratory

• Documented ROS1 fusion positivity by an eligible result from: centralized multiplex molecular testing of tumor tissue at the Sponsor's designated central laboratory under Study BX43361 or available results from a Sponsor pre-approved local, appropriately validated ROS1 fusion test on tumor tissue performed in a Clinical Laboratory Improvement Amendments certified or equivalent laboratory

• Ability to swallow entrectinib intact, without chewing, crushing, or opening the capsules

Locations
United States
Alabama
University of South Alabama
WITHDRAWN
Mobile
California
Southern California Kaiser Permanente
WITHDRAWN
Los Angeles
Colorado
Rocky Mountain Cancer Centers - Lone Tree
WITHDRAWN
Lone Tree
Florida
Mount Sinai Medical Center
WITHDRAWN
Miami Beach
Michigan
University Of Michigan
WITHDRAWN
Ann Arbor
Oregon
Oregon Health Sciences Uni
WITHDRAWN
Portland
Northwest Cancer Specialists, P.C.
RECRUITING
Tigard
Pennsylvania
Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
Thompson Cancer Survival Center
WITHDRAWN
Knoxville
Baptist Cancer Center
WITHDRAWN
Memphis
Texas
The University of Texas MD Anderson Cancer Center
WITHDRAWN
Houston
Mays Cancer Center, UT Health San Antonio
WITHDRAWN
San Antonio
Virginia
Virginia Cancer Specialists (Fairfax) - USOR
WITHDRAWN
Fairfax
Other Locations
Australia
Lifehouse
WITHDRAWN
Camperdown
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
One Clinical Research
RECRUITING
Nedlands
GenesisCare North Shore
WITHDRAWN
St Leonards
Westmead Hospital
WITHDRAWN
Westmead
Belgium
GHdC Site Les Viviers
WITHDRAWN
Charleroi
UZ Gent
ACTIVE_NOT_RECRUITING
Ghent
Brazil
Hospital de Cancer de Barretos
RECRUITING
Barretos
Oncocentro Belo Horizonte
ACTIVE_NOT_RECRUITING
Belo Horizonte
Clínica de Oncologia Reichow
WITHDRAWN
Blumenau
Crio - Centro Regional Integrado de Oncologia
WITHDRAWN
Fortaleza
Hospital Nossa Senhora da Conceicao
RECRUITING
Porto Alegre
Santa Casa de Misericordia de Porto Alegre
WITHDRAWN
Porto Alegre
Oncoclinicas Rio de Janeiro S.A.
WITHDRAWN
Rio De Janeiro
Hospital Sao Rafael - HSR
WITHDRAWN
Salvador
Instituto do Cancer do Estado de Sao Paulo - ICESP
RECRUITING
São Paulo
Instituto do Cancer Brasil
WITHDRAWN
Três Lagoas
COT - Centro Oncologico do Triangulo
WITHDRAWN
Uberlândia
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Chile
K2 Oncology
RECRUITING
Providencia
Centro de Estudios Clínicos SAGA
WITHDRAWN
Santiago
OrlandiOncología
WITHDRAWN
Santiago
RedSalud Vitacura
RECRUITING
Santiago
James Lind Centro de Investigación Del Cáncer
WITHDRAWN
Temuco
China
Beijing Cancer Hospital
WITHDRAWN
Beijing
Hunan Cancer Hospital
COMPLETED
Changsha
Hunan Cancer Hospital
ACTIVE_NOT_RECRUITING
Changsha
Xinqiao Hospital of Third Military Medical University
ACTIVE_NOT_RECRUITING
Chongqing
Shandong Cancer Hospital
ACTIVE_NOT_RECRUITING
Jinan
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
WITHDRAWN
Nanjing
The affiliated hospital of Qingdao university
WITHDRAWN
Qingdao
Shanghai Pulmonary Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Tianjin Medical University Cancer Institute & Hospital
WITHDRAWN
Tianjing
Union Hospital Tongji Medical College Huazhong University of Science and Technology
WITHDRAWN
Wuhan
Shanxi Cancer Hospital
WITHDRAWN
Xi'an
Colombia
Clinica De La Costa
WITHDRAWN
Barranquilla
Hospital Universitario San Ignacio
RECRUITING
Bogotá
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
RECRUITING
Bogota, D.c.
Instituto Cancerología Medellin
WITHDRAWN
Medellín
Costa Rica
Clinica CIMCA
WITHDRAWN
San José
ICIMED Instituto de Investigación en Ciencias Médicas
WITHDRAWN
San José
France
CHU Angers,Service de Pneumologie
WITHDRAWN
Angers
Polyclinique Bordeaux Nord Aquitaine
WITHDRAWN
Bordeaux
Hôpital Ambroise Paré - Boulogne-Billancourt
WITHDRAWN
Boulogne-billancourt
Centre Francois Baclesse
RECRUITING
Caen
Centre Leon Berard
RECRUITING
Lyon
Hopital Nord
RECRUITING
Marseille
Hôpitaux D'Instruction Des Armees Begin
WITHDRAWN
Saint-mandé
CHU Strasbourg - Nouvel Hopital Civil
RECRUITING
Strasbourg
Hia Sainte Anne
RECRUITING
Toulon
CHU de Toulouse - Hôpital Larrey
RECRUITING
Toulouse
Germany
Helios Klinikum Emil von Behring GmbH
COMPLETED
Berlin
Klinikum Chemnitz gGmbH
WITHDRAWN
Chemnitz
Klinikum Esslingen
WITHDRAWN
Esslingen Am Neckar
Thoraxklinik Heidelberg gGmbH
WITHDRAWN
Heidelberg
LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik V, Campus Innenstadt
WITHDRAWN
München
Universitätsklinikum Regensburg
WITHDRAWN
Regensburg
Universitätsklinikum Würzburg
WITHDRAWN
Würzburg
Hong Kong Special Administrative Region
Queen Mary Hospital
WITHDRAWN
Hong Kong
India
Medanta-The Medicity
RECRUITING
Gurgaon
Apollo Gleneagles Hospital
RECRUITING
Kolkata
Tata Memorial Hospital
WITHDRAWN
Mumbai
Rajiv Gandhi Cancer Inst.&Research Center
WITHDRAWN
New Delhi
Israel
Rambam Medical Center
WITHDRAWN
Haifa
Rabin Medical Center-Beilinson Campus
WITHDRAWN
Petah Tikva
Italy
IRCCS Giovanni Paolo II Istituto Oncologico
WITHDRAWN
Bari
Asst Degli Spedali Civili Di Brescia
WITHDRAWN
Brescia
Azienda Ospedaliero-Universitaria Careggi
WITHDRAWN
Florence
IRCCS A.O.U San MArtino - IST
WITHDRAWN
Genoa
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
RECRUITING
Meldola
Asst Grande Ospedale Metropolitano Niguarda
ACTIVE_NOT_RECRUITING
Milan
Irccs Istituto Europeo di Oncologia (IEO)
WITHDRAWN
Milan
A.O. Universitaria S. Luigi Gonzaga
WITHDRAWN
Orbassano
IRCCS Istituto Oncologico Veneto (IOV)
WITHDRAWN
Padua
Ospedale P. Pederzoli Casa di cura Privata
WITHDRAWN
Peschiera Del Garda (vr)
Azienda Ospedaliera San Camillo Forlanini
WITHDRAWN
Rome
IRCCS Istituto Regina Elena (IFO)
WITHDRAWN
Rome
Japan
Aichi Cancer Center Hospital
WITHDRAWN
Aichi
Hirosaki University Hospital
WITHDRAWN
Aomori
National Cancer Center East
WITHDRAWN
Chiba
Shikoku Cancer Center
WITHDRAWN
Ehime
Kurume University Hospital
ACTIVE_NOT_RECRUITING
Fukuoka
NHO Kyushu Cancer Center
ACTIVE_NOT_RECRUITING
Fukuoka
Kobe City Medical Center General Hospital
ACTIVE_NOT_RECRUITING
Hyōgo
National Hospital Organization Himeji Medical Center
WITHDRAWN
Hyōgo
Kagoshima University Hospital
ACTIVE_NOT_RECRUITING
Kagoshima
Kanagawa Cancer Center
WITHDRAWN
Kanagawa
Kumamoto University Hospital
ACTIVE_NOT_RECRUITING
Kumamoto
Sendai Kousei Hospital
WITHDRAWN
Miyagi
Nara Medical University Hospital
WITHDRAWN
Nara
Niigata Cancer Center Hospital
WITHDRAWN
Niigata
Kurashiki Central Hospital
WITHDRAWN
Okayama
Okayama University Hospital
WITHDRAWN
Okayama
NHO Kinki Chuo Chest Medical Center
WITHDRAWN
Osaka
Osaka City General Hospital
WITHDRAWN
Osaka
Osaka International Cancer Institute
WITHDRAWN
Osaka
Kindai University Hospital
ACTIVE_NOT_RECRUITING
Ōsaka-sayama
Shizuoka Cancer Center
WITHDRAWN
Shizuoka
Juntendo University Hospital
ACTIVE_NOT_RECRUITING
Tokyo
Komagome Hospital
WITHDRAWN
Tokyo
The Cancer Institute Hospital of JFCR
ACTIVE_NOT_RECRUITING
Tokyo
Tottori University Hospital
WITHDRAWN
Tottori
National Hospital Organization Yamaguchi - Ube Medical Center
WITHDRAWN
Yamaguchi
Mexico
Centro de Investigación Oncologica Galerias
RECRUITING
Aguascalientes
Hospital Civil de Guadalajara Fray Antonio Alcalde
RECRUITING
Guadalajara
ARKE Estudios Clínicos S.A. de C.V.
RECRUITING
Mexico City
Clinstile S.A de C.V.
RECRUITING
Mexico City
Netherlands
Maastricht University Medical Center
RECRUITING
Maastricht
New Zealand
Auckland City Hospital, Cancer and Blood Research
WITHDRAWN
Auckland
Norway
Oslo university hospital Radiumhospitalet
WITHDRAWN
Oslo
Poland
Instytut Genetyki i Immunologii GENIM
WITHDRAWN
Lublin
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
WITHDRAWN
Olsztyn
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
WITHDRAWN
Poznan
Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu
COMPLETED
Wroc?aw
Republic of Korea
Chungbuk National University Hospital
WITHDRAWN
Cheongju-si
Kyungpook National University Chilgok Hospital
ACTIVE_NOT_RECRUITING
Daegu
Pusan National University Yangsan Hospital
ACTIVE_NOT_RECRUITING
Gyeongsangnam-do
Chonnam National University Hwasun Hospital
ACTIVE_NOT_RECRUITING
Jeollanam-do
Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITING
Seongnam-si
Asan Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Kangbuk Samsung Hospital
ACTIVE_NOT_RECRUITING
Seoul
Korea University Guro Hospital
ACTIVE_NOT_RECRUITING
Seoul
Serbia
Hospital Medical Center Bezanijska kosa
WITHDRAWN
Belgrade
University Clinical Centre of Serbia
WITHDRAWN
Belgrade
Institute for Pulmonary Diseases of Vojvodina
WITHDRAWN
Kamenitz
Univ Clinical Center Kragujevac
WITHDRAWN
Kragujevac
Singapore
National Cancer Centre
RECRUITING
Singapore
Tan Tock Seng Hospital
WITHDRAWN
Singapore
Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
WITHDRAWN
A Coruña
Hospital General Univ. de Alicante
WITHDRAWN
Alicante
Hospital Universitari Vall d'Hebron
WITHDRAWN
Barcelona
Complejo Hospitalario Universitario Insular?Materno Infantil
WITHDRAWN
Las Palmas De Gran Canaria
Hospital Ramon y Cajal
WITHDRAWN
Madrid
Hospital Universitario 12 de Octubre
WITHDRAWN
Madrid
Hospital Universitario La Paz
WITHDRAWN
Madrid
Hospital Regional Universitario Carlos Haya
WITHDRAWN
Málaga
Hospital Universitario Virgen del Rocio
WITHDRAWN
Seville
Hospital Clínico Universitario de Valencia
WITHDRAWN
Valencia
Sweden
Sahlgrenska University Hospital
ACTIVE_NOT_RECRUITING
Gothenburg
Karolinska Universitetssjukhuset, Solna
ACTIVE_NOT_RECRUITING
Stockholm
Taiwan
Taipei Medical University ?Shuang Ho Hospital
WITHDRAWN
New Taipei City
National Cheng Kung Univ Hosp
WITHDRAWN
Tainan City
National Taiwan Uni Hospital
WITHDRAWN
Taipei
Taipei Medical University Hospital
WITHDRAWN
Taipei
Taipei Municipal Wan Fang Hospital
WITHDRAWN
Taipei
Taipei Veterans General Hospital
WITHDRAWN
Taipei
Chang Gung Memorial Hospital - Linkou
WITHDRAWN
Taoyuan District
Taichung Veterans General Hospital
ACTIVE_NOT_RECRUITING
Xitun Dist.
Thailand
Faculty of Med. Siriraj Hosp.
RECRUITING
Bangkok
Rajavithi Hospital
RECRUITING
Bangkok
Oncology Unit, Faculty of Medicine, Vajira Hospital
RECRUITING
Dusit
Songklanagarind Hospital
RECRUITING
Songkhla
Turkey
Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
WITHDRAWN
Ankara
Gazi Uni Medical Faculty Hospital
WITHDRAWN
Ankara
Liv Hospital Ankara
WITHDRAWN
Ankara
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
WITHDRAWN
Bakirkoy / Istanbul
Dicle University Faculty of Medicine
WITHDRAWN
Diyarbakır
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
WITHDRAWN
Erzurum
Marmara Uni Faculty of Medicine
WITHDRAWN
Istanbul
Medipol University Medical Faculty
WITHDRAWN
Istanbul
Medikal Park Samsun
WITHDRAWN
Samsun
Medical Park Seyhan Hospital
WITHDRAWN
Seyhan
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
North Middlesex Hospital
WITHDRAWN
Harlow
Barts & London School of Med
WITHDRAWN
London
Royal Marsden Hospital
WITHDRAWN
London
Christie Hospital Nhs Trust
RECRUITING
Manchester
Contact Information
Primary
Reference Study ID Number: BO42777 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2033-09-01
Participants
Target number of participants: 71
Treatments
Experimental: Cohort A1: ALK-Positive (alectinib arm)
Participants will receive alectinib 600 mg orally twice daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first
Active_comparator: Cohort A1: ALK-positive (durvalumab arm)
Participants will receive 1500 mg of intravenous (IV) durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first
Experimental: Cohort A2: ROS 1-positive (entrectinib arm)
Participants will receive entrectinib 600 mg orally once daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first.~Cohort A2 has been closed to enrollment.
Active_comparator: Cohort A2: ROS 1-positive (durvalumab arm)
Participants will receive 1500 mg of IV durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first~Cohort A2 has been closed to enrollment.
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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