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 (SKYSCRAPER-15)

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 was 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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Placebo

Detailed Description

With Protocol Amendment 2, enrollment will be stopped. The primary objective of the study has been changed to a safety objective and no other analysis will be conducted

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
    • Centro Oncologico Korben
• Australia
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60336-232
      • Crio - Centro Regional Integrado de Oncologia
  • Estado de Bahia
    • Salvador, Bahia, Estado de Bahia, Brazil, 40170-380
      • Nucleo de Oncologia da Bahia - NOB
  • Rio Grande do Sul
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
      • Hospital de Clinicas de Passo Fundo
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceição
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Hospital de Cancer de Barretos
    • São Paulo, São Paulo, Brazil, 01509-010
      • Hospital A. C. Camargo
• China
  • Changzhou, China, 213003
    • Changzhou First People's Hospital
  • Guangzhou, China, 510080
    • Guangdong General Hospital
  • Guangzhou, China, 510080
    • The First Affiliated Hospital of Sun Yat-sen University
  • Jinan, China, 250117
    • Shandong Cancer Hospital
  • Kunming, China, 650118
    • Yunnan Cancer Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Ningbo, China, DUMMY_VALUE
    • Ningbo No.2 Hospital
  • Shengyang, China, 110042
    • Liaoning Provincial Cancer Hospital
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
• Italy
  • Veneto
    • Peschiera Del Garda (VR), Veneto, Italy, 37019
      • Ospedale P. Pederzoli Casa Di Cura Privata
• Japan
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Osaka, Japan, 589-8511
    • Kindai University Hospital
• Poland
  • Warsaw, Poland, 01-138
    • Instytut Gruzlicy i Chorob Pluc
• South Korea
  • Busan, South Korea, 602-739
    • Pusan National University Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Gyeonggi-do, South Korea, 16247
    • St. Vincent's Hospital
  • Gyeongsangnam-do, South Korea, 50612
    • Pusan National University Yangsan Hospital
  • Seongnam-si, South Korea, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
• Taiwan
  • Kaohsiung City, Taiwan, 824
    • E-DA hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Zhongzheng Dist., Taiwan, 106
    • National Taiwan University Cancer Center
• Thailand
  • Bangkok, Thailand, 10300
    • Vajira Hospital
• Turkey (Türkiye)
  • Bakirkoy / Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) 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 epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atezolizumab + Tiragolumab; Participants will receive atezolizumab and tiragolumab intravenously (IV).	Drug: Atezolizumab; Atezolizumab will be administered IV.; Other Names: Tecentriq; RO5541267; Drug: Tiragolumab; Tiragolumab will be administered IV.; Other Names: MTIG7192A; RO7092284
Placebo Comparator: Atezolizumab + Placebo; Participants will receive atezolizumab and placebo IV.	Drug: Atezolizumab; Atezolizumab will be administered IV.; Other Names: Tecentriq; RO5541267; Drug: Placebo; Placebo will be administered IV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Adverse Events (AEs)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Adverse Events (AEs)	Up to approximately 15 years
Overall Survival (OS)	Up to approximately 15 years
DFS Rate	Year 3, Year 5, Year 7
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
Serum Concentration of Tiragolumab	Up to approximately 1 year
Serum Concentration of Atezolizumab	Up to approximately 1 year
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab	Up to approximately 1 year
Percentage of Participants With ADAs to Atezolizumab	Up to approximately 1 year

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Actual): December 16, 2025
• Study Completion (Actual): December 16, 2025

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Substandard Drugs; Pharmaceutical Preparations; atezolizumab; Tiragolumab
• Other Study ID Numbers: GO45006; 2023-506696-10-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
• IPD Sharing Access Criteria: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No