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


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Trial ID: NCT04513925


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.

Official Title

A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


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

   - 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


drug: Atezolizumab

drug: Tiragolumab

drug: Durvalumab


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Grace Hwang

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