A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SKYSCRAPER-02)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225080

Enrollment

490

Registered

2020-02-19

Start date

2020-03-16

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

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 confirmed extensive-stage small cell lung cancer (ES-SCLC) - No prior systemic treatment for ES-SCLC - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) - Adequate hematologic and end-organ function - Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

Exclusion criteria

Exclusion criteria: - Symptomatic or actively progressing central nervous system (CNS) metastases - Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome - 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 on screening chest computed tomography (CT) scan - Positive test result for human immunodeficiency virus (HIV) - Active hepatitis B or hepatitis C - Severe infection at the time of randomization - Treatment with any other investigational agent with therapeutic intent within 28 days prior to randomization - 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 randomization

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

Australia, Austria, Belgium, Brazil, Czech Republic, Germany, Greece, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States of America

Outcome results

None listed

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