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Phase 3 N=829 Randomized Treatment

A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer (NSCLC)

Enrolled (actual)
829
Serious AEs
32.6%
Results posted
Jun 2026
Primary outcome: Primary: Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS) — 16.59; 19.35 months — p=0.7586

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Atezolizumab (Drug); Tiragolumab (Drug); Durvalumab (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hoffmann-La Roche
Primary completion
May 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
16.59; 19.35 0.7586
PRIMARY
PFS, as Assessed by an IRF in FAS
13.83; 14.19 0.9948
SECONDARY
Overall Survival (OS) in PPAS
54.83; NA 0.9601
SECONDARY
PFS, as Assessed by the Investigator in PPAS
18.53; 19.35 0.3542
SECONDARY
Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS
47.5; 45.5 0.6387
SECONDARY
Confirmed ORR, as Assessed by the Investigator in PPAS
37.2; 37.0 0.9545
SECONDARY
Duration of Response (DOR), as Assessed by an IRF in PPAS
28.09; 43.63
SECONDARY
DOR, as Assessed by the Investigator in PPAS
30.16; 36.17
SECONDARY
Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS
NA; NA 0.4647
SECONDARY
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
12.22; 10.78 0.6343
SECONDARY
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS
NA; NA 0.3162
SECONDARY
TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS
NA; 33.28 0.3680
SECONDARY
TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
NA; 41.43 0.7177
SECONDARY
OS in FAS
45.77; 45.57 0.8195
SECONDARY
PFS, as Assessed by the Investigator in FAS
13.83; 16.69 0.4802
SECONDARY
Confirmed ORR, as Assessed by an IRF in FAS
39.5; 40.9 0.8188
SECONDARY
Confirmed ORR, as Assessed by the Investigator in FAS
34.6; 33.9 0.8779
SECONDARY
DOR, as Assessed by an IRF in FAS
32.39; 36.44
SECONDARY
DOR, as Assessed by the Investigator in FAS
30.16; 35.25
SECONDARY
TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS
NA; NA 0.8459
SECONDARY
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS
11.53; 11.07 0.7662
SECONDARY
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS
NA; NA 0.8035
SECONDARY
TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS
NA; 27.86 0.0475 sig
SECONDARY
TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS
NA; 41.43 0.8399
SECONDARY
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS
55.36; 59.99; 48.97; 51.52; 42.92; 46.06 0.3462
SECONDARY
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
56.29; 60.08; 50.18; 52.64; 42.89; 45.00 0.4405
SECONDARY
OS Rate at 12, 24, 36, and 48 Months in PPAS
86.53; 84.95; 69.24; 72.18; 62.63; 60.85 0.6454
SECONDARY
Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS
33.25; 31.67 0.9563
SECONDARY
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS
52.08; 55.86; 44.33; 45.90; 38.47; 39.02 0.2863
SECONDARY
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS
54.69; 58.42; 45.10; 48.92; 38.96; 39.92 0.2888
SECONDARY
OS Rate at 12, 24, 36, and 48 Months in FAS
83.24; 83.65; 66.32; 66.98; 55.61; 56.66 0.8746
SECONDARY
TTDM, as Assessed by the Investigator in FAS
25.23; 26.18 0.9659
SECONDARY
Number of Participants With Adverse Events (AEs)
402; 397
SECONDARY
Number of Participants With Cytokine Release Syndrome (CRS)
0; 0

Summary

The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.

Eligibility Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
  • Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
  • At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
  • The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
  • No progression during or following concurrent platinum-based CRT
  • A known PD-L1 result
  • Life expectancy >/= 12 weeks
  • Adequate hematologic and end-organ function
  • Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
  • Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
  • Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab

Exclusion Criteria

  • Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
  • NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
  • Any evidence of Stage IV disease
  • Treatment with sequential CRT for locally advanced NSCLC
  • Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
  • Any Grade >2 unresolved toxicity from previous CRT
  • Grade >= 2 pneumonitis from prior CRT
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis
  • History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
  • Prior allogeneic stem cell or solid organ transplantation
  • Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
  • Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
  • Treatment with systemic immunosuppressive medication
  • Women who are pregnant, or breastfeeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04513925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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