Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
SKYSCRAPER-03
Clinical summary
Summary
Eligible patients will be randomised to receive intravenous atezolizumab and tiragolumab in combination, or intravenous durvalumab alone, on specified days of each 28-day cycle for a maximum 13 cycles.
Conditions
This trial is treating people with non-small cell lung cancer
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hoffmann-La Roche
Scientific 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
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