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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2024
• Main ID: NCT04294810
• Date of registration: 02/03/2020
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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
• Scientific 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
• Date of first enrolment: March 4, 2020
• Target sample size: 620
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04294810
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Brazil, China, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Clinical Trial
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Tiragolumab

Drug: Atezolizumab

Drug: Matching Placebo

Primary Outcome(s)

Percentage of Participants With Cytokine-Release Syndrome (CRS) [Time Frame: Up to approximately 59 months]

Percentage of Participants With Adverse Events (AEs) [Time Frame: 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)]

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)]

Secondary Outcome(s)

Investigator-Assessed PFS Rates at 6 Months and 12 Months [Time Frame: 6 months, 12 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 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)]

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)]

OS in the Secondary Analysis Set [Time Frame: From randomization to death from any cause (up to approximately 59 months)]

OS Rates at 12 Months and 24 Months [Time Frame: 12 months, 24 months]

Secondary ID(s)

2019-002925-31

GO41717

2022-502482-17-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors