Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04294810
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2020-03-02
Brief 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
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKYSCRAPER-01
Brief 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 EGFR mutation or anaplastic lymphoma kinase ALK translocation Eligible participants will be randomized in a 11 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002925-31 | EUDRACT_NUMBER | None | None |
| 2022-502482-17-00 | REGISTRY | EU Trial Number | None |