Solid Tumors Clinical Trial
Official title:
Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors
The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.
| Status | Recruiting |
| Enrollment | 15000 |
| Est. completion date | December 22, 2032 |
| Est. primary completion date | August 21, 2032 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | General Inclusion Criteria: - Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol - Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial Inclusion Criteria for Participants with Stage III NSCLC - Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Inclusion Criteria for Participants with Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC Requiring Adjuvant Treatment - Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017) - Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor) - Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol - Representative FFPE tumor specimen obtained prior to the start of any treatment - ECOG Performance Status of 0 or 1 General Exclusion Criteria: - History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death - Any condition that may affect the interpretation of study results - Significant liver or cardiovascular disease - Prior allogenic stem-cell or solid-organ transplantation |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Lifehouse | Camperdown | New South Wales |
| Australia | Peter MacCallum Cancer Centre; Medical Oncology | Melbourne | Victoria |
| Australia | One Clinical Research | Nedlands | Western Australia |
| Australia | Northern Cancer Institute | St Leonards | New South Wales |
| Australia | Westmead Hospital; Medical Oncology and Pallative Care | Westmead | New South Wales |
| Belgium | GHdC Site Notre Dame | Charleroi | |
| Belgium | UZ Gent | Gent | |
| Brazil | Hospital de Cancer de Barretos | Barretos | SP |
| Brazil | Oncocentro Belo Horizonte | Belo Horizonte | MG |
| Brazil | Clínica de Oncologia Reichow | Blumenau | SC |
| Brazil | Crio - Centro Regional Integrado de Oncologia | Fortaleza | CE |
| Brazil | Hospital Nossa Senhora da Conceicao | Porto Alegre | RS |
| Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS |
| Brazil | Oncoclinicas Rio de Janeiro S.A. | Rio de Janeiro | RJ |
| Brazil | Hospital Sao Rafael - HSR | Salvador | BA |
| Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP | Sao Paulo | SP |
| Brazil | COT - Centro Oncologico do Triangulo | Uberlandia | MG |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Chile | Centro de Estudios Clínicos SAGA | Santiago | |
| Chile | OrlandiOncología | Santiago | |
| Chile | James Lind Centro de Investigación Del Cáncer | Temuco | |
| Colombia | Clinica De La Costa | Barranquilla | |
| Colombia | Hospital Universitario San Ignacio | Bogota | |
| Colombia | Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo | Bogota, D.C. | |
| Colombia | Instituto Cancerologia Medellin; Clinica Las Americas | Medellin | |
| Costa Rica | Clinica CIMCA | San José | |
| Costa Rica | ICIMED Instituto de Investigación en Ciencias Médicas | San José | |
| France | CHU de Toulouse - Hôpital Larrey | Toulouse | |
| Hong Kong | Queen Mary Hospital; Dept. of Clinical Oncology | Hong Kong | |
| Israel | Rambam Medical Center; Oncology | Haifa | |
| Israel | Rabin Medical Center-Beilinson Campus; Davidof Institute | Petach Tikva | |
| Italy | ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica | Brescia | Lombardia |
| Italy | Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Firenze | Toscana |
| Italy | IRCCS A.O.U San MArtino - IST; U.O. Oncologia Medica 2 | Genova | Liguria |
| Italy | IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna |
| Italy | Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milano | Lombardia |
| Italy | Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia | Milano | Lombardia |
| Italy | A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica | Orbassano | Piemonte |
| Italy | IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova | Veneto |
| Japan | Aichi Cancer Center Hospital | Aichi | |
| Japan | Hirosaki University Hospital | Aomori | |
| Japan | Shikoku Cancer Center | Ehime | |
| Japan | Kurume University Hospital | Fukuoka | |
| Japan | NHO Kyushu Cancer Center | Fukuoka | |
| Japan | Kobe City Medical Center General Hospital | Hyogo | |
| Japan | National Hospital Organization Himeji Medical Center | Hyogo | |
| Japan | Kagoshima University Hospital | Kagoshima | |
| Japan | Kanagawa Cancer Center | Kanagawa | |
| Japan | Kumamoto University Hospital | Kumamoto | |
| Japan | Sendai Kousei Hospital | Miyagi | |
| Japan | Nara Medical University Hospital | Nara | |
| Japan | Niigata Cancer Center Hospital | Niigata | |
| Japan | Kurashiki Central Hospital | Okayama | |
| Japan | Okayama University Hospital | Okayama | |
| Japan | NHO Kinki Chuo Chest Medical Center | Osaka | |
| Japan | Osaka City General Hospital | Osaka | |
| Japan | Osaka International Cancer Institute | Osaka | |
| Japan | Kindai University Hospital ; Faculty of Medicine | Osaka-sayama | |
| Japan | Shizuoka Cancer Center | Shizuoka | |
| Japan | Juntendo University Hospital | Tokyo | |
| Japan | Komagome Hospital | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR | Tokyo | |
| Japan | Tottori University Hospital | Tottori | |
| Japan | National Hospital Organization Yamaguchi - Ube Medical Center | Yamaguchi | |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju si | |
| Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Gyeongsangnam-do | |
| Korea, Republic of | Chonnam National University Hwasun Hospital | Jeollanam-do | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| New Zealand | Auckland City Hospital, Cancer and Blood Research | Auckland | |
| Norway | Oslo universitetssykehus HF, Ullevål, Kreftsenteret | Oslo | |
| Poland | Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdansk | |
| Poland | Instytut Genetyki i Immunologii GENIM | Lublin | |
| Poland | Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers | Warszawa | |
| Poland | Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu; Oddzia? Onkologii Klinicznej VII | Wroc?aw | |
| Serbia | Hospital Medical Center Bezanijska kosa; Clinic for Medical Oncology | Belgrade | |
| Serbia | University Clinical Centre of Serbia; Clinic for Pulmonology | Belgrade | |
| Serbia | Univ Clinical Center Kragujevac; Clinic for Pulmonology | Kragujevac | |
| Serbia | Institute for pulmonary diseases of Vojvodina | Sremska Kamenica | |
| Singapore | National Cancer Centre; Medical Oncology | Singapore | |
| Singapore | Tan Tock Seng Hospital; Oncology | Singapore | |
| Spain | Hospital General Univ. de Alicante; Servicio de Oncologia | Alicante | |
| Spain | Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia | Las Palmas de Gran Canaria | LAS Palmas |
| Spain | Hospital Universitario La Paz; Servicio de Oncologia | Madrid | |
| Spain | Hospital Regional Universitario Carlos Haya; Servicio de Oncologia | Malaga | |
| Taiwan | Taipei Medical University Shuang Ho Hospital | New Taipei City | |
| Taiwan | National Cheng Kung Univ Hosp | Tainan | |
| Taiwan | Taipei Medical University Hospital | Taipei | |
| Taiwan | Taipei Municipal Wan Fang Hospital | Taipei | |
| Taiwan | National Taiwan Uni Hospital | Taipei City | |
| Taiwan | Taipei Veterans General Hospital | Taipei City | |
| Taiwan | Chang Gung Memorial Hospital - Linkou | Taoyuan | |
| Taiwan | Taichung Veterans General Hospital | Xitun Dist. | |
| Thailand | National Cancer Institute; Department of Medicine | Bangkok | |
| Thailand | Rajavithi Hospital; Division of Medical Oncology | Bangkok | |
| Thailand | Siriraj Hospital; Medical Oncology Unit | Bangkok | |
| Thailand | Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine | Dusit | |
| Thailand | Central Chest Institute of Thailand; Department of Medicine; Division of Respiratory Medicine | Nonthaburi | |
| Thailand | Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory | Songkhla | |
| Turkey | Adana Baskent University Hospital; Medical Oncology | Adana | |
| Turkey | Gazi Uni Medical Faculty Hospital; Oncology Dept | Ankara | |
| Turkey | Liv Hospital Ankara; Medical Oncology | Ankara | |
| Turkey | Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji | Bakirkoy / Istanbul | |
| Turkey | Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department | Erzurum | |
| Turkey | Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | |
| Turkey | Marmara Uni Faculty of Medicine; Medical Oncology | Istanbul | |
| Turkey | Medipol University Medical Faculty; Oncology Department | Istanbul | |
| Turkey | Medikal Park Samsun | Samsun | |
| United Kingdom | Barts & London School of Med; Medical Oncology | London | |
| United Kingdom | Royal Marsden Hospital; Dept of Med-Onc | London | |
| United Kingdom | Christie Hospital Nhs Trust; Medical Oncology | Manchester | |
| United States | Texas Oncology, P.A. | Austin | Texas |
| United States | Oncology & Hematology Associates of Southwest Virginia, Inc | Blacksburg | Virginia |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Thompson Cancer Survival Center | Knoxville | Tennessee |
| United States | Rocky Mountain Cancer Centers-Penrose Pavillion | Longmont | Colorado |
| United States | Baptist Cancer Center | Memphis | Tennessee |
| United States | Hillman Cancer Center;Medical Oncology | Pittsburgh | Pennsylvania |
| United States | Oregon Health Sciences Uni | Portland | Oregon |
| United States | Mays Cancer Center, UT Health San Antonio | San Antonio | Texas |
| United States | Texas Oncology, P.A. | San Antonio | Texas |
| United States | Southern California Kaiser Permanente | San Diego | California |
| United States | Arizona Oncology Associates, PC - HOPE | Tucson | Arizona |
| United States | Texas Oncology- Northeast Texas | Tyler | Texas |
| United States | Northwest Cancer Specialists | Vancouver | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Italy, Japan, Korea, Republic of, New Zealand, Norway, Poland, Serbia, Singapore, Spain, Taiwan, Thailand, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants with evaluable biomarker results | Up to 10 years | ||
| Primary | Proportion of participants eligible for a linked Roche clinical trial | Up to 10 years |
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|---|---|---|---|
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