Non-small Cell Lung Cancer (NSCLC)Phase 3SKYSCRAPER-15NCT06267001
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
A Phase 3 study testing Atezolizumab and Tiragolumab in people with Non-small Cell Lung Cancer (NSCLC), run by Hoffmann-La Roche at 37 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Atezolizumab and Tiragolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 37 sitesin 11 countries
- Study dates
- 21 Mar 2024to 16 Dec 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
37 sites in 11 countries.
37 sites in 11 countries
China10 sites
Changzhou First People's Hospital
Changzhou, 213003
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510080
Shandong Cancer Hospital
Jinan, 250117
Yunnan Cancer Hospital
Kunming, 650118
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008
Ningbo No.2 Hospital
Ningbo, DUMMY_VALUE
Liaoning Provincial Cancer Hospital
Shengyang, 110042
Tianjin Cancer Hospital
Tianjin, 300060
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030
Zhejiang Cancer Hospital
Zhejiang, 310022
South Korea10 sites
Pusan National University Hospital
Busan, 602-739
Kyungpook National University Chilgok Hospital
Daegu, 41404
St. Vincent's Hospital
Gyeonggi-do, 16247
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Korea University Guro Hospital
Seoul, 08308
Brazil5 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-232
Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia, Estado de Bahia, 40170-380
Taiwan3 sites
E-DA Hospital
Kaohsiung City, 824
Taichung Veterans General Hospital
Taichung, 407
National Taiwan University Cancer Center
Zhongzheng Dist., 106
Australia2 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Monash Health
Clayton, Victoria, 3168
Japan2 sites
Hiroshima University Hospital
Hiroshima, 734-8551
Kindai University Hospital
Osaka, 589-8511
Argentina1 site
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
Italy1 site
Ospedale P. Pederzoli Casa di cura Privata
Peschiera Del Garda (VR), Veneto, 37019
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
About this study
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
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.
Read the 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
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Atezolizumab, Tiragolumab, Placebo
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq; RO5541267
Atezolizumab will be administered IV.
TiragolumabDrug
Also called MTIG7192A; RO7092284
Tiragolumab will be administered IV.
PlaceboDrug
Placebo will be administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab + Tiragolumab | Experimental | Participants will receive atezolizumab and tiragolumab intravenously (IV). Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Atezolizumab + Placebo | Placebo comparator | Participants will receive atezolizumab and placebo IV. Receives: Drug: Atezolizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
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.
Measured: Up to 16.4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start21 Mar 2024
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Why it stopped: Decision to terminate study was driven by results from preceding tiragolumab study (SKYSCRAPER-06;NCT04619797) \& sponsor's strategic priorities, not due to safety risks or quality reasons for any of molecules/combinations investigated in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267001
- Sponsor's protocol ID
- GO45006
- Other IDs
- 2023-506696-10-00, 2023
- Acronym
- SKYSCRAPER-15
- Status last verified
- May 2026
- First submitted
- 12 Feb 2024
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06267001
- Acronym / sponsor ID
- SKYSCRAPER-15 / GO45006
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to terminate study was driven by results from preceding tiragolumab study (SKYSCRAPER-06;NCT04619797) \& sponsor's strategic priorities, not due to safety risks or quality reasons for any of molecules/combinations investigated in this study.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab + Tiragolumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants will receive atezolizumab and tiragolumab intravenously (IV). |
| Atezolizumab + Placebo | Placebo comparator | Drug: Atezolizumab, Drug: PlaceboParticipants will receive atezolizumab and placebo IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: Tecentriq; RO5541267Atezolizumab will be administered IV. | Drug | Atezolizumab + Placebo, Atezolizumab + Tiragolumab |
| TiragolumabAlso: MTIG7192A; RO7092284Tiragolumab will be administered IV. | Drug | Atezolizumab + Tiragolumab |
| PlaceboPlacebo will be administered IV. | Drug | Atezolizumab + Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
37 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atezolizumab and Tiragolumab in people with Non-small Cell Lung Cancer (NSCLC), run by Hoffmann-La Roche at 37 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in China, South Korea, Brazil, Taiwan, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to 16.4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.