A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— SKYSCRAPER-15  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267001
• Other study ID #: GO45006
• Secondary ID: 2023-506696-10-0
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2024
• Est. completion date: June 30, 2039

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: GO45006 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Atezolizumab
Atezolizumab will be administered IV.
• Tiragolumab
Tiragolumab will be administered IV.
• Placebo
Placebo will be administered IV.

Locations

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
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	Hospital A. C. Camargo; Oncologia	Sao Paulo	SP
China	Changzhou First People's Hospital; Oncology	Changzhou
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	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	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
Japan	Kindai University Hospital	Osaka
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
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
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	UNM Lovelace	Albuquerque	New Mexico
United States	The Oncology Institute of Hope and Innovation; Cerritos	Cerritos	California
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	University of California, San Francisco; Medical Center	San Francisco	California
United States	Springfield Clinic	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  China,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

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