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 (SKYSCRAPER-01)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225137

Enrollment

560

Registered

2020-03-23

Start date

2020-06-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non small-cell lung cancer

Interventions

investigational material(s) Generic name etc : Tiragolumab INN of investigational material : Tiragolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC - No prior systemic treatment for metastatic NSCLC - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay - Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) - Adequate hematologic and end-organ function

Exclusion criteria

Exclusion criteria: - Known mutation in the EGFR gene or an anaplastic lymphoma kinase (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 prior to screening, 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 - 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

Design outcomes

Primary

Measure	Time frame
efficacy Observation/Inspection, RECIST v1.1	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Observation/Inspection, RECIST v1.1	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026