Screening Study for Participants With Malignant Tumors
Launched by HOFFMANN-LA ROCHE · Jun 13, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at patients with solid tumors, specifically to analyze the tumor tissue for certain markers. These markers will help determine if participants qualify for a related clinical trial involving a new treatment. The study is currently recruiting patients aged 65 to 74 and is open to all genders.
To be eligible, participants must have a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that is either locally advanced or requires additional treatment. They need to have a tumor sample that meets the study's criteria and be willing to participate in the linked trial. Participants can expect to undergo screening to check their tumor's biomarker status, which is important for their treatment options. It’s also essential that they have no significant health issues that could interfere with the study results. Overall, this trial aims to help identify the best treatment pathways for patients with specific types of lung cancer.
Gender
ALL
Eligibility criteria
- 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
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Westmead, New South Wales, Australia
Bangkok, , Thailand
Lyon, , France
Madrid, , Spain
Hong Kong, , Hong Kong
Porto Alegre, Rs, Brazil
Singapore, , Singapore
Gent, , Belgium
Toronto, Ontario, Canada
Charleroi, , Belgium
Haifa, , Israel
Madrid, , Spain
Bordeaux, , France
Tottori, , Japan
Milano, Lombardia, Italy
Houston, Texas, United States
Pittsburgh, Pennsylvania, United States
Khon Kaen, , Thailand
Mumbai, Maharashtra, India
Niigata, , Japan
Okayama, , Japan
Osaka, , Japan
London, , United Kingdom
Seoul, , Korea, Republic Of
Augsburg, , Germany
Sevilla, , Spain
Caen, , France
Bangkok, , Thailand
Portland, Oregon, United States
Porto Alegre, Rs, Brazil
Kumamoto, , Japan
Bangkok, , Thailand
Seongnam Si, , Korea, Republic Of
Melbourne, Victoria, Australia
Shizuoka, , Japan
Seongnam Si, , Korea, Republic Of
Malaga, , Spain
Sao Paulo, Sp, Brazil
Meldola, Emilia Romagna, Italy
Bangkok, , Thailand
Aichi, , Japan
Taipei, , Taiwan
London, , United Kingdom
Barretos, Sp, Brazil
Esslingen, , Germany
Tokyo, , Japan
Regensburg, , Germany
Sevilla, , Spain
Taoyuan, , Taiwan
Hyogo, , Japan
Songkhla, , Thailand
Porto Alegre, Rio Grande Do Sul, Brazil
Okayama, , Japan
Tokyo, , Japan
Jeollanam Do, , Korea, Republic Of
Camperdown, New South Wales, Australia
Westmead, New South Wales, Australia
Salvador, Ba, Brazil
Bogota, , Colombia
Adana, , Turkey
Istanbul, , Turkey
Maastricht, , Netherlands
London, , United Kingdom
Tucson, Arizona, United States
Seoul, , Korea, Republic Of
San Diego, California, United States
Ankara, , Turkey
Seoul, , Korea, Republic Of
Mexico City, , Mexico
Guadalajara, Jalisco, Mexico
Taipei City, , Taiwan
Melbourne, Victoria, Australia
Padova, Veneto, Italy
Songkhla, , Thailand
New Taipei City, , Taiwan
Memphis, Tennessee, United States
Alicante, , Spain
Brescia, Lombardia, Italy
Seongnam Si, , Korea, Republic Of
Petach Tikva, , Israel
Fukuoka, , Japan
Haifa, , Israel
Manchester, , United Kingdom
Kanagawa, , Japan
Tainan, , Taiwan
Oslo, , Norway
Dusit, , Thailand
Diyarbakir, , Turkey
Istanbul, , Turkey
Nara, , Japan
Erzurum, , Turkey
Fukuoka, , Japan
Osaka, , Japan
Toulouse, , France
Sremska Kamenica, , Serbia
Tyler, Texas, United States
Daegu, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Knoxville, Tennessee, United States
Malaga, , Spain
Osaka, , Japan
Hong Kong, , Hong Kong
St Leonards, New South Wales, Australia
Oslo, , Norway
San José, , Costa Rica
Gdańsk, , Poland
Xitun Dist., , Taiwan
Roma, Lazio, Italy
Taipei City, , Taiwan
Gyeongsangnam Do, , Korea, Republic Of
Firenze, Toscana, Italy
Bari, Puglia, Italy
Hyogo, , Japan
Istanbul, , Turkey
San José, , Costa Rica
Tokyo, , Japan
San Antonio, Texas, United States
Orbassano, Piemonte, Italy
Ehime, , Japan
Miyagi, , Japan
Barranquilla, , Colombia
Milano, Lombardia, Italy
Tucson, Arizona, United States
Kagoshima, , Japan
Yamaguchi, , Japan
Angers, , France
Austin, Texas, United States
Santiago, , Chile
Milano, Lombardia, Italy
Aomori, , Japan
Roma, Lazio, Italy
Brescia, Lombardia, Italy
Warszawa, , Poland
Kolkata, West Bengal, India
Pittsburgh, Pennsylvania, United States
Auckland, , New Zealand
Petach Tikva, , Israel
Würzburg, , Germany
Temuco, , Chile
Osaka Sayama, , Japan
Singapore, , Singapore
Strasbourg, , France
Bangkok, , Thailand
Samsun, , Turkey
Mexico City, Mexico City (Federal District), Mexico
Uberlandia, Mg, Brazil
Rio De Janeiro, Rj, Brazil
Santiago, , Chile
Blumenau, Santa Catarina, Brazil
St Leonards, New South Wales, Australia
Rio De Janeiro, , Brazil
Blumenau, Sc, Brazil
Ankara, , Turkey
Bakirkoy / Istanbul, , Turkey
Medellin, , Colombia
Toulon, , France
Belo Horizonte, Mg, Brazil
Nedlands, Western Australia, Australia
Colorado Springs, Colorado, United States
Blacksburg, Virginia, United States
Vancouver, Washington, United States
Ankara, , Turkey
Lublin, , Poland
Longmont, Colorado, United States
Tyler, Texas, United States
Fortaleza, Ce, Brazil
Istanbul, , Turkey
Osaka Sayama, , Japan
Las Palmas De Gran Canaria, Las Palmas, Spain
Gda?Sk, , Poland
Las Palmas De Gran Canaria, Las Palmas, Spain
Bogota, D.C., , Colombia
Singapore, , Singapore
Sao Jose Do Rio Preto, São Paulo, Brazil
Taipei, , Taiwan
München, , Germany
Singapore, , Singapore
Seyhan, , Turkey
Santiago, , Chile
Belgrade, , Serbia
Gdansk, , Poland
Kragujevac, , Serbia
Kragujevac, , Serbia
Nonthaburi, , Thailand
Bangkok, , Thailand
San Antonio, Texas, United States
Belgrade, , Serbia
Wroc?Aw, , Poland
Ciudad De México, , Mexico
Seyhan, , Turkey
Porto Alegre, Rs, Brazil
Cheongju Si, , Korea, Republic Of
Genova, Liguria, Italy
München, , Germany
Miyagi, , Japan
Osaka Sayama, , Japan
Osaka, , Japan
Sao Paulo, , Brazil
Medellin, , Colombia
Angers, , France
Toulon, , France
Gurgaon, Haryana, India
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, São Paulo, Brazil
Meldola, Emilia Romagna, Italy
Milano, Lombardia, Italy
Firenze, Toscana, Italy
Salvador, Bahia, Brazil
Roma, Lazio, Italy
Chang Mai, , Thailand
New Delhi, Delhi, India
Barretos, São Paulo, Brazil
Orbassano, Piemonte, Italy
London, , United Kingdom
Manchester, , United Kingdom
Fortaleza, Ceará, Brazil
Padova, Veneto, Italy
München Gauting, , Germany
Ankara, , Turkey
San Antonio, Texas, United States
Belo Horizonte, Minas Gerais, Brazil
Uberlandia, Minas Gerais, Brazil
Gurgaon, Haryana, India
Genova, Liguria, Italy
Wroc?Aw, , Poland
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Alicante, , Spain
Dusit, , Thailand
Nonthaburi, , Thailand
Istanbul, , Turkey
Ankara, , Turkey
Charleroi, , Belgium
Aguascalientes, , Mexico
Santiago, , Chile
Providencia, , Chile
Barretos, , Brazil
Sao Jose Do Rio Preto, , Brazil
Mexico City, , Mexico
Fortaleza, , Brazil
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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