Non-Small Cell Lung CancerPhase 3SKYSCRAPER-01NCT04294810
A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
A Phase 3 study testing Atezolizumab and Tiragolumab in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 134 sites in 23 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- 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
- 620 participants
- Where
- 134 sitesin 23 countries
- Study dates
- 4 Mar 2020to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
- No prior systemic treatment for metastatic NSCLC
- High tumor tissue PD-L1 expression
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function
- For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
Who cannot join
- Known mutation in the EGFR gene or an ALK fusion oncogene
- Symptomatic, untreated, or actively progressing central nervous system metastases
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Severe infection within 4 weeks prior to initiation of study treatment
Show all 11Show fewer
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
Trial locations and contacts
134 sites in 23 countries.
134 sites in 23 countries
China18 sites
Beijing Cancer Hospital
Beijing, 100142
The First Hospital of Jilin University
Changchun, 130021
West China Hospital, Sichuan University
Chengdu, 610041
Chongqing Cancer Hospital
Chongqing, 400030
Fujian Cancer Hospital
Fuzhou, 350014
Hainan General Hospital
Haikou, 570311
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, 310016
Harbin Medical University Cancer Hospital
Harbin, 150081
Jinan Central Hospital
Jinan, 250013
Meizhou People's Hospital
Meizhou, 514031
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330200
Nantong Tumor Hospital
Nantong, 226361
Zhongshan Hospital Fudan University
Shanghai, 200032
Fudan University Shanghai Cancer Center
Shanghai, 200120
Shanghai Pulmonary Hospital
Shanghai, 200433
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
The First Affiliated Hospital of Xiamen University
Xiamen, 361003
Zhejiang Cancer Hospital
Zhejiang, 310022
Japan12 sites
Aichi Cancer Center
Aichi, 464-8681
National Cancer Center Hospital East
Chiba, 277-8577
Kyushu University Hospital
Fukuoka, 812-8582
Sendai Kousei Hospital
Miyagi, 980-0873
Niigata Cancer Center Hospital
Niigata, 951-8566
Osaka International Cancer Institute
Osaka, 541-8567
Kindai University Hospital
Osaka, 589-8511
Saitama Cancer Center
Saitama, 362-0806
NHO Kinki-Chuo Chest Medical Center
Sakaishi, 591-8555
Shizuoka Cancer Center
Shizuoka, 411-8777
National Cancer Center Hospital
Tokyo, 104-0045
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
South Korea12 sites
Chungbuk National University Hospital
Cheongju-si, 28644
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Ajou University Medical Center
Gyeonggi-do, 16499
Gachon University Gil Medical Center
Incheon, 21565
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Medical Center
Seoul, 03181
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Korea University Guro Hospital
Seoul, 08308
Samsung Medical Center
Seoul, 6351
St. Vincent's Hospital
Suwon, 442-723
Italy10 sites
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, 83100
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, 20141
Asst Di Monza
Monza, Lombardy, 20900
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, 80131
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, 10043
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, 06156
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00151
Policlinico Universitario "Agostino Gemelli"
Rome, Lazio, 00168
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
United States9 sites
Rocky Mountain Cancer Center - Denver
Denver, Colorado, 80220
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia, 22031
SCRI Oncology Partners
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06520
US oncology research at Minnesota Oncology
Saint Paul, Minnesota, 55102
Onc & Hem Assoc SW Virginia
Salem, Virginia, 24153
SCRI Florida Cancer Specialists North
St. Petersburg, Florida, 33705
SCRI Florida Cancer Specialists PAN
Tallahassee, Florida, 32308
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684
Spain8 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, 28222
Hospital Universitario Virgen del Rocío
Madrid, 41013
Hospital Regional Universitario de Malaga
Málaga, 29010
Hosp Clinico Univ Lozano Blesa
Zaragoza, 50009
Taiwan8 sites
Chang Gung Memorial Hospital - Linkou Branch
Guishan Dist., 33305
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taipei Medical University ?Shuang Ho Hospital
New Taipei City, 23561
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung Uni Hospital
Tainan, 704
Taipei Veterans General Hospital
Taipei, 112
National Taiwan University Hospital
Zhongzheng Dist., 10048
Germany6 sites
Krankenhaus Nordwest
Frankfurt, 60488
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, 06120
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein
Löwenstein, 74245
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48153
Klinik Schillerhöhe
Stuttgart, 70376
Turkey (Türkiye)6 sites
Adana Baskent University Hospital
Adana, 01120
Hacettepe University Medical Faculty
Ankara, 06100
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, 34098
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, 35110
Goztepe Prof.Dr. Suleyman Yalcin City Hospital
Kadiköy, 34722
Inonu University Medical Faculty of Medicine
Malatya, 44280
Russia5 sites
Main Military Clinical Hospital named after N.N. Burdenko
Moscow, Moscow Oblast, 105229
MEDSI Clinical Hospital on Pyatnitsky Highway
Moscow, Moscow Oblast, 143422
Institute of Oncology
Saint Petersburg, Sankt-Peterburg, 189646
St. Petersburg Med Univ
Saint Petersburg, Sankt-Peterburg, 197089
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
Saint Petersburg, Sankt-Peterburg, 197758
Mexico4 sites
Health Pharma Professional Research
CD Mexico, Mexico CITY (federal District), 03810
Cryptex Investigacion Clinica SA de CV
México, Mexico CITY (federal District), 06100
AVIX Investigación Clínica S.C
Monterrey, Nuevo León, 64710
Cuidados oncologicos
Querétaro City, Querétaro, 76000
Peru4 sites
Instituto Regional de Enfermedades Neoplásicas del Sur
Arequipa, 5154
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038
Clinica Internacional, Sede San Borja
Lima, Lima 41
Clinica Ricardo Palma
San Isidro, Lima 27
Thailand4 sites
Chulalongkorn Hospital
Bangkok, 10330
Ramathibodi Hospital
Bangkok, 10400
Faculty of Med. Siriraj Hosp.
Bangkok, 10700
Songklanagarind Hospital
Songkhla, 90110
Australia3 sites
Austin Hospital Olivia Newton John Cancer Centre
Heidelberg, Victoria, 3084
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Austria3 sites
Ordensklinikum Linz Elisabethinen
Linz, 4020
Klinik Penzing
Vienna, 1140
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210
Greece3 sites
Sotiria Hospital
Athens, 104 31
Metropolitan Hospital
Athens, 185 47
University Hospital of Larissa
Larissa, 411 10
Hungary3 sites
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, 1121
Matrai Gyogyintezet
Mátraháza, 3233
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
Szolnok, 5004
Netherlands3 sites
Ziekenhuis Gelderse Vallei
Ede, 6716 RP
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
Hagaziekenhuis, locatie Leyweg
The Hague, 2545 AA
Poland3 sites
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, 10-357
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, 60-569
Switzerland3 sites
Inselspital Bern
Bern, 3010
CHUV
Lausanne, 1011
HOCH Health Ostschweiz, Kantonsspital St. Gallen
Sankt Gallen, 9000
Ukraine3 sites
City Clinical Hospital #4
Dnipropetrovsk, 49102
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
Kryvyi Rih, 50048
Uzhgorod Nat. University Central Municip Hosp
Uzhhorod, 88000
Brazil2 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000
Serbia2 sites
Clinical Center of Serbia
Belgrade, 11000
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
About this study
Official title: A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Atezolizumab, Tiragolumab, Matching 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
Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
TiragolumabDrug
Also called MTIG7192A
Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Matching PlaceboDrug
Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Tiragolumab + Atezolizumab | Experimental | Participants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity. Receives: Drug: Atezolizumab; Drug: Tiragolumab |
| Placebo + Atezolizumab | Placebo comparator | Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity. Receives: Drug: Atezolizumab; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Overall Survival (OS) in the Primary Analysis Set
Measured: From randomization to death from any cause (up to approximately 59 months)
Percentage of Participants With Adverse Events (AEs)
Measured: Up to approximately 59 months
Percentage of Participants With Cytokine-Release Syndrome (CRS)
Measured: Up to approximately 59 months
Secondary outcomes (7)
Investigator-Assessed PFS in the Secondary Analysis Set
Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
OS in the Secondary Analysis Set
Measured: From randomization to death from any cause (up to approximately 59 months)
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Measured: From randomization up to approximately 59 months
Investigator-Assessed Duration of Response (DOR)
Measured: From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Investigator-Assessed PFS Rates at 6 Months and 12 Months
Measured: 6 months, 12 months
OS Rates at 12 Months and 24 Months
Measured: 12 months, 24 months
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
Measured: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start4 Mar 2020
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294810
- Sponsor's protocol ID
- GO41717
- Other IDs
- 2019-002925-31, 2022-502482-17-00, 2019
- Acronym
- SKYSCRAPER-01
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2020
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Publications
Peters S, Herbst R, Horinouchi H, Paz-Ares L, Johnson M, Solomon BJ, Gumus M, Erman M, Bondarenko I, Kim DW, Felip E, Morabito A, Bryl M, Urban L, Nosaki K, Reck M, Meng R, Stroud C, Kundu P, Wen X, Patil NS, Huang M, Troutman S, Matheny C, Cho BC. SKYSCRAPER-01: Tiragolumab in Combination With Atezolizumab in Previously Untreated PD-L1-High, Locally Advanced, Unresectable or Metastatic Non-Small Cell Lung Cancer. J Clin Oncol. 2026 Sep;44(25):2400-2408. doi: 10.1200/JCO-25-02777. Epub 2026 Jul 27.
PubMed 42507968Beaufils A, De Martino J, Jiang X, Blanchard T, Fraunhoffer N, Mendes D, Pignolet C, Bourega T, Meneghetti AR, Sainath S, Albuquerque M, Colnot N, Tihy M, Turpin A, Ben Abdelghani M, Wei A, Mitry E, Lecomte T, Biagi J, Artru P, Evesque L, Lambert A, Renouf DJ, Mauduit M, Dusetti NJ, Hammel P, Conroy T, Bachet JB, de Mestier L, Rebours V, Cros J, Kather JN, Nicolle R. Developing a Histology-Based Artificial Intelligence Biomarker to Predict Adjuvant Chemotherapy Benefit in Pancreatic Cancer. J Clin Oncol. 2026 Sep 10;44(26):2507-2516. doi: 10.1200/JCO-26-00327. Epub 2026 Jul 27.
PubMed 42507965
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04294810
- Acronym / sponsor ID
- SKYSCRAPER-01 / GO41717
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
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 the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiragolumab + Atezolizumab | Experimental | Drug: Atezolizumab, Drug: TiragolumabParticipants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity. |
| Placebo + Atezolizumab | Placebo comparator | Drug: Atezolizumab, Drug: Matching PlaceboParticipants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity. |
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
- Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
- No prior systemic treatment for metastatic NSCLC
- High tumor tissue PD-L1 expression
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Key exclusion criteria (11 listed)
- Known mutation in the EGFR gene or an ALK fusion oncogene
- Symptomatic, untreated, or actively progressing central nervous system metastases
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
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: TecentriqAtezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle. | Drug | Placebo + Atezolizumab, Tiragolumab + Atezolizumab |
| TiragolumabAlso: MTIG7192ATiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle. | Drug | Tiragolumab + Atezolizumab |
| Matching PlaceboMatching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle. | Drug | Placebo + Atezolizumab |
Primary outcome
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set
Time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Overall Survival (OS) in the Primary Analysis Set
Time frame: From randomization to death from any cause (up to approximately 59 months)
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 59 months
Percentage of Participants With Cytokine-Release Syndrome (CRS)
Time frame: Up to approximately 59 months
7 secondary outcomes
Investigator-Assessed PFS in the Secondary Analysis Set
Time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
OS in the Secondary Analysis Set
Time frame: From randomization to death from any cause (up to approximately 59 months)
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Time frame: From randomization up to approximately 59 months
Investigator-Assessed Duration of Response (DOR)
Time frame: From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Investigator-Assessed PFS Rates at 6 Months and 12 Months
Time frame: 6 months, 12 months
OS Rates at 12 Months and 24 Months
Time frame: 12 months, 24 months
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
Time frame: From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 42507968Peters S, Herbst R, Horinouchi H, Paz-Ares L, Johnson M, Solomon BJ, Gumus M, Erman M, Bondarenko I, Kim DW, Felip E, Morabito A, Bryl M, Urban L, Nosaki K, Reck M, Meng R, Stroud C, Kundu P, Wen X, Patil NS, Huang M, Troutman S, Matheny C, Cho BC. SKYSCRAPER-01: Tiragolumab in Combination With Atezolizumab in Previously Untreated PD-L1-High, Locally Advanced, Unresectable or Metastatic Non-Small Cell Lung Cancer. J Clin Oncol. 2026 Sep;44(25):2400-2408. doi: 10.1200/JCO-25-02777. Epub 2026 Jul 27.
- Derived from this study: PubMed 42507965Beaufils A, De Martino J, Jiang X, Blanchard T, Fraunhoffer N, Mendes D, Pignolet C, Bourega T, Meneghetti AR, Sainath S, Albuquerque M, Colnot N, Tihy M, Turpin A, Ben Abdelghani M, Wei A, Mitry E, Lecomte T, Biagi J, Artru P, Evesque L, Lambert A, Renouf DJ, Mauduit M, Dusetti NJ, Hammel P, Conroy T, Bachet JB, de Mestier L, Rebours V, Cros J, Kather JN, Nicolle R. Developing a Histology-Based Artificial Intelligence Biomarker to Predict Adjuvant Chemotherapy Benefit in Pancreatic Cancer. J Clin Oncol. 2026 Sep 10;44(26):2507-2516. doi: 10.1200/JCO-26-00327. Epub 2026 Jul 27.
- 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 Trial study director
Hoffmann-La Roche
134 sites in 23 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, run by Hoffmann-La Roche at 134 sites in 23 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 11 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: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 134 sites in China, Japan, South Korea, Italy, United States and 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294810, which also lists 2 linked publications.
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 30 Jan 2026.