A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation (SKYSCRAPER-03)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225327

Enrollment

800

Registered

2020-08-21

Start date

2020-09-25

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

Locally Advanced, Unresectable Stage III NSCLC

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: - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology - Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (CRT) - At least two prior cycles of platinum-based chemotherapy concurrent with radiotherapy (cCRT), which must be completed within 1 to 42 days prior to randomization in the study - The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (+- 10 percent [%]) gray (Gy) (54 Gy to 66 Gy) - No progression during or following concurrent platinum-based CRT - Tumor PD-L1 expression - Life expectancy >/= 12 weeks - Adequate hematologic and end-organ function

Exclusion criteria

Exclusion criteria: - Any history of prior NSCLC - NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene - Any evidence of Stage IV disease - Treatment with sequential CRT for locally advanced NSCLC - Participants with locally advanced NSCLC who have progressed during or after the definitive concurrent CRT prior to randomization - Any Grade >2 unresolved toxicity from previous CRT - Grade >= 2 pneumonitis from prior CRT - 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 - History of malignancy other than NSCLC within 5 years prior to screening - Prior allogeneic stem cell or solid organ transplantation - Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1 - Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents - Treatment with systemic immunosuppressive medication

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