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)

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Atezolizumab; Drug: Placebo; Drug: Tiragolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06267001

GO45006

2023-506696-10-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.

Full description

With Protocol Amendment 2, enrollment will be stopped. The primary objective of the study has been changed to a safety objective and no other analysis will be conducted

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) 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.

Exclusion 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 epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups, including a placebo group

Atezolizumab + Tiragolumab

Experimental group

Description:

Participants will receive atezolizumab and tiragolumab intravenously (IV).

Treatment:

Drug: Tiragolumab

Drug: Atezolizumab

Atezolizumab + Placebo

Placebo Comparator group

Description:

Participants will receive atezolizumab and placebo IV.

Treatment:

Drug: Placebo

Drug: Atezolizumab