Non-small Cell Lung Cancer (NSCLC) Clinical Trial
— SKYSCRAPER-15Official title:
A Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.
| Status | Recruiting |
| Enrollment | 1150 |
| Est. completion date | June 30, 2039 |
| Est. primary completion date | March 31, 2034 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Eastern Cooperative Oncology Group performance status of 0 or 1 - Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology - Participants must have had complete resection of NSCLC - Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy - Participants must have recovered adequately from surgery and from adjuvant chemotherapy - Tumor cell PD-L1 expression at >/= 1% - Adequate hematologic and end-organ function. Exclusion Criteria: - Any history of prior NSCLC within the last 5 years - Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy - NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Britanico; Oncologia | Buenos Aires | |
| Argentina | Centro Oncologico Korben; Oncology | Ciudad Autonoma Buenos Aires | |
| Argentina | CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC | Ciudad Autonoma de Buenos Aires | |
| Argentina | Sanatorio Allende | Cordoba | |
| Argentina | Sanatorio Parque S.A. | Rosario | |
| Australia | Cancer Research SA | Adelaide | South Australia |
| Australia | Sunshine Coast University Hospital; The Adem Crosby Centre | Birtinya | Queensland |
| Australia | Monash Health | Clayton | Victoria |
| Australia | Greenslopes Private Hospital; Gallipoli Research Centre | Greenslopes | Queensland |
| Brazil | Hospital de Cancer de Barretos | Barretos | SP |
| Brazil | Crio - Centro Regional Integrado de Oncologia | Fortaleza | CE |
| Brazil | Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia | Passo Fundo | RS |
| Brazil | Hospital Nossa Senhora da Conceicao | Porto Alegre | RS |
| Brazil | Real Hospital Portugues de Beneficencia | Recife | PE |
| Brazil | Nucleo de Oncologia da Bahia - NOB | Salvador, Bahia | BA |
| Brazil | Hospital A. C. Camargo; Oncologia | Sao Paulo | SP |
| China | Changzhou First People's Hospital; Oncology | Changzhou | |
| China | West China Hospital, Sichuan University | Chengdu | |
| China | Guangdong General Hospital | Guangzhou | |
| China | The First Affiliated Hospital of Sun Yat-sen University | Guangzhou City | |
| China | Shandong Cancer Hospital | Jinan | |
| China | Yunnan Cancer Hospital | Kunming | |
| China | The First Affiliated Hospital of Nanchang University | Nanchang City | |
| China | Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing City | |
| China | Ningbo No.2 Hospital | Ningbo | |
| China | The Affiliated Hospital Of Qingdao University | Qingdao City | |
| China | Shanghai Pulmonary Hospital | Shanghai | |
| China | Zhongshan Hospital Fudan University | Shanghai | |
| China | Liaoning Provincial Cancer Hospital | Shengyang | |
| China | Tianjin Cancer Hospital | Tianjin | |
| China | Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan City | |
| China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | |
| China | Zhejiang Cancer Hospital | Zhejiang | |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | |
| Hong Kong | Queen Mary Hospital; Centre of Cancer Medicine | Hong Kong | |
| Japan | National Cancer Center Hospital East | Chiba | |
| Japan | Kyushu University Hospital | Fukuoka | |
| Japan | Hiroshima University Hospital | Hiroshima | |
| Japan | Sendai Kousei Hospital | Miyagi | |
| Japan | Oita University Hospital | Oita | |
| Japan | Okayama University Hospital | Okayama | |
| Japan | Kindai University Hospital | Osaka | |
| Japan | Saitama Cancer Center | Saitama | |
| Japan | The Cancer Institute Hospital of JFCR | Tokyo | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju si | |
| Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu | |
| Korea, Republic of | St. Vincent's Hospital | Gyeonggi-do | |
| 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 | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | Ulsan University Hosiptal | Ulsan | |
| Slovakia | Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie | Bratislava | |
| Taiwan | E-DA Hospital; Chest | Kaohsiung | |
| Taiwan | Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine | Kaohsiung | |
| Taiwan | Taichung Veterans General Hospital; Dept of Internal Medicine | Taichung | |
| Taiwan | Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology | Taipei | |
| Taiwan | Tri-Service General Hospital; Dept. of Internal Medicine | Taipei | |
| Thailand | Chulalongkorn Hospital; Medical Oncology | Bangkok | |
| Thailand | Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology | Chang Mai | |
| United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
| United States | UNM Lovelace | Albuquerque | New Mexico |
| United States | VA Medical Center - Ann Arbor | Ann Arbor | Michigan |
| United States | Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana | Billings | Montana |
| United States | The Oncology Institute of Hope and Innovation; Cerritos | Cerritos | California |
| United States | Virginia Cancer Specialists (Fairfax) - USOR | Fairfax | Virginia |
| United States | Texas Oncology (Flower Mound) - USOR | Flower Mound | Texas |
| United States | The Oncology Institute of Hope and Innovation - Florida | Fort Lauderdale | Florida |
| United States | Corewell Health | Grand Rapids | Michigan |
| United States | Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia |
| United States | Asante Rogue Regional Medical Center | Medford | Oregon |
| United States | Baptist Cancer Center | Memphis | Tennessee |
| United States | SCRI Oncology Partners | Nashville | Tennessee |
| United States | Texas Oncology, P.A.; San Antonio Northeast | San Antonio | Texas |
| United States | University of California, San Francisco; Medical Center | San Francisco | California |
| United States | Springfield Clinic | Springfield | Illinois |
| United States | James A. Haley Veterans Hospital | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Argentina, Australia, Brazil, China, Hong Kong, Japan, Korea, Republic of, Slovakia, Taiwan, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease-free Survival (DFS) | Up to approximately 10 years | ||
| Secondary | Percentage of Participants With Adverse Events (AEs) | Up to approximately 15 years | ||
| Secondary | Overall Survival (OS) | Up to approximately 15 years | ||
| Secondary | DFS Rate | Year 3, Year 5, Year 7 | ||
| Secondary | Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) | Up to approximately 1 year | ||
| Secondary | Serum Concentration of Tiragolumab | Up to approximately 1 year | ||
| Secondary | Serum Concentration of Atezolizumab | Up to approximately 1 year | ||
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab | Up to approximately 1 year | ||
| Secondary | Percentage of Participants With ADAs to Atezolizumab | Up to approximately 1 year |
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