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)

May 14, 2026 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
        • Centro Oncológico 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 Clínicas de Passo Fundo
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Hospital de Cancer de Barretos
  • China
      • Changzhou, China, 213003
        • Changzhou First People's 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 16.4 months
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.
Up to 16.4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 15 years
Up to approximately 15 years
Overall Survival (OS)
Time Frame: Up to approximately 15 years
Up to approximately 15 years
DFS Rate
Time Frame: Year 3, Year 5, Year 7
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)
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Serum Concentration of Tiragolumab
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Serum Concentration of Atezolizumab
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Percentage of Participants With ADAs to Atezolizumab
Time Frame: Up to approximately 1 year
Up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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