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

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

• Atezolizumab (Drug), also known as Tecentriq; RO5541267: Atezolizumab will be administered IV.
• Tiragolumab (Drug), also known as MTIG7192A; RO7092284: Tiragolumab will be administered IV.
• Placebo (Drug): Placebo will be administered IV.

Primary outcomes

• Number of Participants With Adverse Events (AEs) [Up to 16.4 months]: An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Number of Participants With Adverse Events (AEs) (Primary), Count of participants, Participants: Atezolizumab ± Placebo 26; Tiragolumab + Atezolizumab 21

Adverse events

Time frame: Up to 16.4 months

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2024-09-06)

• Clinical Trials, Study director, Hoffmann-La Roche

NIH grants: 2023