A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT05170204

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2033-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

Participants will receive oral alectinib twice daily with food.

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

Group Type ACTIVE_COMPARATOR

Durvalumab

Intervention Type DRUG

Participants will receive IV durvalumab every 4 weeks.

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.

Group Type EXPERIMENTAL

Entrectinib

Intervention Type DRUG

Participants will receive oral entrectinib once daily, with or without food.

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.

Group Type ACTIVE_COMPARATOR

Durvalumab

Intervention Type DRUG

Participants will receive IV durvalumab every 4 weeks.

Interventions

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Alectinib

Participants will receive oral alectinib twice daily with food.

Intervention Type DRUG

Entrectinib

Participants will receive oral entrectinib once daily, with or without food.

Intervention Type DRUG

Durvalumab

Participants will receive IV durvalumab every 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Any history of previous NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease)
* Any evidence of Stage IV disease, including, but not limited to, the following: pleural effusion, pericardial effusion, brain metastases, history of intracranial hemorrhage or spinal cord hemorrhage, bone metastases, distant metastases
* If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (T4 disease): when pleural fluid is visible on both the CT scan and chest X-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; participants with exudative pleural effusions are excluded regardless of cytology; participants with effusions that are minimal (i.e., not visible on chest X-ray) that are too small to safely tap are eligible
* NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing
* Liver disease, characterized by any of the following: impaired excretory function (e.g., hyperbilirubinemia), synthetic function, or other conditions of decompensated liver disease, such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices or active viral or active autoimmune, alcoholic, or other types of acute hepatitis
* Positive hepatitis B surface antigen (HBsAg) test at screening
* Participants known to be positive for hepatitis C virus (HCV) antibody (Ab) are excluded with the following exception: participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible
* HIV infection: participants are excluded if not well-controlled as defined by the protocol
* Known active tuberculosis
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan
* Grade \>/= 2 pneumonitis from prior cCRT or sCRT
* Any Grade \> 2 unresolved toxicity from prior cCRT or sCRT
* Any gastrointestinal (GI) disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study; participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
* History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
* Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
* Major surgical procedure, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with exceptions defined by the protocol
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Prior allogeneic stem cell or solid organ transplantation
* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
* Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of patient safety or study results
* Any prior Grade \>/= 3 immune-mediated adverse event or any unresolved Grade \> 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents


* Presence of clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
* NSCLC known to have one or more of the following ALK point mutations, as identified by site local testing or Sponsor central testing: I1171X (where X is any other amino acid), V1180L, G1202R
* Symptomatic bradycardia
* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina; participants with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \< 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
* Prior treatment with ALK inhibitors
* History of hypersensitivity to alectinib, durvalumab, or any of their excipients
* Inability to swallow oral study drug
* Known hereditary problems of galactose intolerance, a congenital lactase deficiency, or glucose-galactose malabsorption
* Pregnancy or breastfeeding, or intending to become pregnant during the study treatment or within 90 days after the final dose of alectinib or durvalumab


* Symptomatic bradycardia
* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina; participants with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \< 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
* Left ventricular ejection fraction less than or equal to 50% observed during the screening for the study
* History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval \> 450 ms from ECGs performed at least 24 hours apart)
* History of additional risk factors for torsade de pointes (e.g., family history of long QT syndrome)
* Familial or personal history of congenital bone disorders or bone metabolism alterations
* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of the treatment
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
* Prior treatment with ROS1 inhibitors
* History of hypersensitivity to entrectinib, durvalumab, and their excipients
* Grade \>/= 3 toxicities due to any prior therapy (e.g., RT) (excluding alopecia) that have not shown improvement or are not stable and are considered to interfere with current study drug
* Known hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
* Grade \>/= 2 peripheral neuropathy
* Pregnancy or intention of becoming pregnant during study treatment, within 35 days after the final dose of entrectinib, or within 90 days after the final dose of durvalumab
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status WITHDRAWN

Southern California Kaiser Permanente

Los Angeles, California, United States

Site Status WITHDRAWN

Rocky Mountain Cancer Centers - Lone Tree

Lone Tree, Colorado, United States

Site Status WITHDRAWN

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status WITHDRAWN

University Of Michigan

Ann Arbor, Michigan, United States

Site Status WITHDRAWN

Oregon Health Sciences Uni

Portland, Oregon, United States

Site Status WITHDRAWN

Northwest Cancer Specialists, P.C.

Tigard, Oregon, United States

Site Status RECRUITING

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Site Status WITHDRAWN

Baptist Cancer Center

Memphis, Tennessee, United States

Site Status WITHDRAWN

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status WITHDRAWN

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

Site Status WITHDRAWN

Virginia Cancer Specialists (Fairfax) - USOR

Fairfax, Virginia, United States

Site Status WITHDRAWN

Lifehouse

Camperdown, New South Wales, Australia

Site Status WITHDRAWN

GenesisCare North Shore

St Leonards, New South Wales, Australia

Site Status WITHDRAWN

Westmead Hospital

Westmead, New South Wales, Australia

Site Status WITHDRAWN

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

One Clinical Research

Nedlands, Western Australia, Australia

Site Status RECRUITING

GHdC Site Les Viviers

Charleroi, , Belgium

Site Status WITHDRAWN

UZ Gent

Ghent, , Belgium

Site Status ACTIVE_NOT_RECRUITING

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status WITHDRAWN

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

Site Status WITHDRAWN

Instituto do Cancer Brasil

Três Lagoas, Mato Grosso do Sul, Brazil

Site Status WITHDRAWN

Oncocentro Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Site Status WITHDRAWN

COT - Centro Oncologico do Triangulo

Uberlândia, Minas Gerais, Brazil

Site Status WITHDRAWN

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status WITHDRAWN

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status WITHDRAWN

Clínica de Oncologia Reichow

Blumenau, Santa Catarina, Brazil

Site Status WITHDRAWN

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Site Status ACTIVE_NOT_RECRUITING

Oncoclinicas Rio de Janeiro S.A.

Rio de Janeiro, , Brazil

Site Status WITHDRAWN

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status WITHDRAWN

K2 Oncology

Providencia, , Chile

Site Status WITHDRAWN

Centro de Estudios Clínicos SAGA

Santiago, , Chile

Site Status WITHDRAWN

OrlandiOncología

Santiago, , Chile

Site Status WITHDRAWN

RedSalud Vitacura

Santiago, , Chile

Site Status RECRUITING

James Lind Centro de Investigación Del Cáncer

Temuco, , Chile

Site Status WITHDRAWN

Beijing Cancer Hospital

Beijing, , China

Site Status WITHDRAWN

Hunan Cancer Hospital

Changsha, , China

Site Status ACTIVE_NOT_RECRUITING

Hunan Cancer Hospital

Changsha, , China

Site Status COMPLETED

Xinqiao Hospital of Third Military Medical University

Chongqing, , China

Site Status ACTIVE_NOT_RECRUITING

Shandong Cancer Hospital

Jinan, , China

Site Status ACTIVE_NOT_RECRUITING

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, , China

Site Status WITHDRAWN

The affiliated hospital of Qingdao university

Qingdao, , China

Site Status WITHDRAWN

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjing, , China

Site Status WITHDRAWN

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

Site Status WITHDRAWN

Shanxi Cancer Hospital

Xi'an, , China

Site Status WITHDRAWN

Clinica De La Costa

Barranquilla, , Colombia

Site Status WITHDRAWN

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogota, D.C., , Colombia

Site Status COMPLETED

Hospital Universitario San Ignacio

Bogotá, , Colombia

Site Status RECRUITING

Instituto Cancerología Medellin

Medellín, , Colombia

Site Status WITHDRAWN

Clinica CIMCA

San José, , Costa Rica

Site Status WITHDRAWN

ICIMED Instituto de Investigación en Ciencias Médicas

San José, , Costa Rica

Site Status WITHDRAWN

CHU Angers,Service de Pneumologie

Angers, , France

Site Status WITHDRAWN

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Site Status WITHDRAWN

Hôpital Ambroise Paré - Boulogne-Billancourt

Boulogne-Billancourt, , France

Site Status WITHDRAWN

Centre Francois Baclesse

Caen, , France

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

Hopital Nord

Marseille, , France

Site Status RECRUITING

Hôpitaux D'Instruction Des Armees Begin

Saint-Mandé, , France

Site Status WITHDRAWN

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, , France

Site Status WITHDRAWN

Hia Sainte Anne

Toulon, , France

Site Status WITHDRAWN

CHU de Toulouse - Hôpital Larrey

Toulouse, , France

Site Status WITHDRAWN

Helios Klinikum Emil von Behring GmbH

Berlin, , Germany

Site Status COMPLETED

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status WITHDRAWN

Klinikum Esslingen

Esslingen am Neckar, , Germany

Site Status WITHDRAWN

Thoraxklinik Heidelberg gGmbH

Heidelberg, , Germany

Site Status WITHDRAWN

LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik V, Campus Innenstadt

München, , Germany

Site Status WITHDRAWN

Universitätsklinikum Regensburg

Regensburg, , Germany

Site Status WITHDRAWN

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status WITHDRAWN

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status WITHDRAWN

Medanta-The Medicity

Gurgaon, Haryana, India

Site Status WITHDRAWN

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status WITHDRAWN

Rajiv Gandhi Cancer Inst.&Research Center

New Delhi, National Capital Territory of Delhi, India

Site Status WITHDRAWN

Apollo Gleneagles Hospital

Kolkata, West Bengal, India

Site Status WITHDRAWN

Rambam Medical Center

Haifa, , Israel

Site Status WITHDRAWN

Rabin Medical Center-Beilinson Campus

Petah Tikva, , Israel

Site Status WITHDRAWN

IRCCS Giovanni Paolo II Istituto Oncologico

Bari, Apulia, Italy

Site Status WITHDRAWN

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna, Italy

Site Status ACTIVE_NOT_RECRUITING

IRCCS Istituto Regina Elena (IFO)

Rome, Lazio, Italy

Site Status WITHDRAWN

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Site Status WITHDRAWN

IRCCS A.O.U San MArtino - IST

Genoa, Liguria, Italy

Site Status WITHDRAWN

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

Site Status WITHDRAWN

Irccs Istituto Europeo di Oncologia (IEO)

Milan, Lombardy, Italy

Site Status WITHDRAWN

Asst Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

Site Status ACTIVE_NOT_RECRUITING

A.O. Universitaria S. Luigi Gonzaga

Orbassano, Piedmont, Italy

Site Status WITHDRAWN

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, Italy

Site Status WITHDRAWN

IRCCS Istituto Oncologico Veneto (IOV)

Padua, Veneto, Italy

Site Status WITHDRAWN

Ospedale P. Pederzoli Casa di cura Privata

Peschiera Del Garda (VR), Veneto, Italy

Site Status WITHDRAWN

Aichi Cancer Center Hospital

Aichi, , Japan

Site Status WITHDRAWN

Hirosaki University Hospital

Aomori, , Japan

Site Status WITHDRAWN

National Cancer Center East

Chiba, , Japan

Site Status WITHDRAWN

Shikoku Cancer Center

Ehime, , Japan

Site Status WITHDRAWN

NHO Kyushu Cancer Center

Fukuoka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Kurume University Hospital

Fukuoka, , Japan

Site Status ACTIVE_NOT_RECRUITING

Kobe City Medical Center General Hospital

Hyōgo, , Japan

Site Status ACTIVE_NOT_RECRUITING

National Hospital Organization Himeji Medical Center

Hyōgo, , Japan

Site Status WITHDRAWN

Kagoshima University Hospital

Kagoshima, , Japan

Site Status ACTIVE_NOT_RECRUITING

Kanagawa Cancer Center

Kanagawa, , Japan

Site Status WITHDRAWN

Kumamoto University Hospital

Kumamoto, , Japan

Site Status ACTIVE_NOT_RECRUITING

Sendai Kousei Hospital

Miyagi, , Japan

Site Status WITHDRAWN

Nara Medical University Hospital

Nara, , Japan

Site Status WITHDRAWN

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status WITHDRAWN

Okayama University Hospital

Okayama, , Japan

Site Status WITHDRAWN

Kurashiki Central Hospital

Okayama, , Japan

Site Status WITHDRAWN

Osaka City General Hospital

Osaka, , Japan

Site Status WITHDRAWN

Osaka International Cancer Institute

Osaka, , Japan

Site Status WITHDRAWN

NHO Kinki Chuo Chest Medical Center

Osaka, , Japan

Site Status WITHDRAWN

Kindai University Hospital

Ōsaka-sayama, , Japan

Site Status ACTIVE_NOT_RECRUITING

Shizuoka Cancer Center

Shizuoka, , Japan

Site Status WITHDRAWN

Juntendo University Hospital

Tokyo, , Japan

Site Status ACTIVE_NOT_RECRUITING

Komagome Hospital

Tokyo, , Japan

Site Status WITHDRAWN

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status ACTIVE_NOT_RECRUITING

Tottori University Hospital

Tottori, , Japan

Site Status WITHDRAWN

National Hospital Organization Yamaguchi - Ube Medical Center

Yamaguchi, , Japan

Site Status WITHDRAWN

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), Mexico

Site Status WITHDRAWN

Centro de Investigación Oncologica Galerias

Aguascalientes, , Mexico

Site Status WITHDRAWN

ARKE Estudios Clínicos S.A. de C.V.

Mexico City, , Mexico

Site Status WITHDRAWN

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status WITHDRAWN

Auckland City Hospital, Cancer and Blood Research

Auckland, , New Zealand

Site Status WITHDRAWN

Oslo university hospital Radiumhospitalet

Oslo, , Norway

Site Status WITHDRAWN

Instytut Genetyki i Immunologii GENIM

Lublin, , Poland

Site Status WITHDRAWN

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, , Poland

Site Status WITHDRAWN

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, , Poland

Site Status WITHDRAWN

Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu

Wroc?aw, , Poland

Site Status COMPLETED

University Clinical Centre of Serbia

Belgrade, , Serbia

Site Status WITHDRAWN

Hospital Medical Center Bezanijska kosa

Belgrade, , Serbia

Site Status WITHDRAWN

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, , Serbia

Site Status WITHDRAWN

Univ Clinical Center Kragujevac

Kragujevac, , Serbia

Site Status WITHDRAWN

National Cancer Centre

Singapore, , Singapore

Site Status RECRUITING

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status WITHDRAWN

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status WITHDRAWN

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status WITHDRAWN

Asan Medical Center

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, Spain

Site Status WITHDRAWN

Complejo Hospitalario Universitario Insular?Materno Infantil

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status WITHDRAWN

Hospital General Univ. de Alicante

Alicante, , Spain

Site Status WITHDRAWN

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status WITHDRAWN

Hospital Ramon y Cajal

Madrid, , Spain

Site Status WITHDRAWN

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status WITHDRAWN

Hospital Universitario La Paz

Madrid, , Spain

Site Status WITHDRAWN

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Site Status WITHDRAWN

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status WITHDRAWN

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status WITHDRAWN

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Karolinska Universitetssjukhuset, Solna

Stockholm, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Taipei Medical University ?Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status WITHDRAWN

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

National Cheng Kung Univ Hosp

Tainan, , Taiwan

Site Status WITHDRAWN

National Taiwan Uni Hospital

Taipei, , Taiwan

Site Status WITHDRAWN

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status WITHDRAWN

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status WITHDRAWN

Taipei Municipal Wan Fang Hospital

Taipei, , Taiwan

Site Status WITHDRAWN

Chang Gung Memorial Hospital - Linkou

Taoyuan District, , Taiwan

Site Status WITHDRAWN

Rajavithi Hospital

Bangkok, , Thailand

Site Status RECRUITING

Faculty of Med. Siriraj Hosp.

Bangkok, , Thailand

Site Status RECRUITING

Oncology Unit, Faculty of Medicine, Vajira Hospital

Dusit, , Thailand

Site Status RECRUITING

Songklanagarind Hospital

Songkhla, , Thailand

Site Status RECRUITING

Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Site Status WITHDRAWN

Gazi Uni Medical Faculty Hospital

Ankara, , Turkey (Türkiye)

Site Status WITHDRAWN

Liv Hospital Ankara

Ankara, , Turkey (Türkiye)

Site Status WITHDRAWN

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

Bakirkoy / Istanbul, , Turkey (Türkiye)

Site Status WITHDRAWN

Dicle University Faculty of Medicine

Diyarbakır, , Turkey (Türkiye)

Site Status WITHDRAWN

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

Erzurum, , Turkey (Türkiye)

Site Status WITHDRAWN

Medipol University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status WITHDRAWN

Marmara Uni Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status WITHDRAWN

Medikal Park Samsun

Samsun, , Turkey (Türkiye)

Site Status WITHDRAWN

Medical Park Seyhan Hospital

Seyhan, , Turkey (Türkiye)

Site Status WITHDRAWN

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status RECRUITING

North Middlesex Hospital

Harlow, , United Kingdom

Site Status WITHDRAWN

Barts & London School of Med

London, , United Kingdom

Site Status WITHDRAWN

Royal Marsden Hospital

London, , United Kingdom

Site Status WITHDRAWN

Christie Hospital Nhs Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Brazil Canada Chile China Colombia Costa Rica France Germany Hong Kong India Israel Italy Japan Mexico Netherlands New Zealand Norway Poland Serbia Singapore South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Reference Study ID Number: BO42777 https://forpatients.roche.com/

Role: CONTACT

888-662-6728

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-503920-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

BO42777

Identifier Type: -

Identifier Source: org_study_id

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