Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
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.
Detailed 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
Interventions
DRUGAtezolizumab
Atezolizumab will be administered IV.
DRUGTiragolumab
Tiragolumab will be administered IV.
DRUGPlacebo
Placebo will be administered IV.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina, Australia, Brazil, China, Italy, Japan, Poland, South Korea, Taiwan, Thailand, Turkey (Türkiye)
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Recruitment details
A total of 56 participants with programmed death-ligand 1 (PD-L1)-positive Stage IIB, IIIA, or select IIIB (T3N2 only) non-small cell lung cancer (NSCLC) following resection and adjuvant platinum-based chemotherapy took part in the study at 35 investigative sites in 10 countries from 21 March 2024 to 16 December 2025.
Pre-assignment details
Participants were randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 42 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 28 | 0 / 24 |
| other Total, other adverse events | 23 / 28 | 21 / 24 |
| serious Total, serious adverse events | 5 / 28 | 9 / 24 |
Outcome results
None listed