A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy (SKYSCRAPER-15)

JRCT ID: jRCT2061230110

Registered date:14/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-small Cell Lung Cancer (NSCLC)
• Date of first enrollment: 01/07/2024
• Target sample size: 1150
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,China,Japan,France,Japan,Greece,Japan,Hong Kong,Japan,Italy,Japan,Republic of Korea,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

Tiragolumab: Tiragolumab will be administered IV
Atezolizumab: Atezolizumab will be administered IV

Outcome(s)

Primary Outcome

efficacy
Observation/Inspection

Secondary Outcome

safety, efficacy, phamacokinetics
Observation/Inspection

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Eastern Cooperative Oncology Group performance status of 0 or 1
Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology
Participants must have had complete resection of NSCLC
Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy
Participants must have recovered adequately from surgery and from adjuvant chemotherapy
Tumor cell PD-L1 expression at >/= 1%
Adequate hematologic and end-organ function

Exclude criteria

Any history of prior NSCLC within the last 5 years
Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene

Related Information

• Primary Sponsor: Raymond Meng
• Secondary ID(s): NCT06267001