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 (SKYSCRAPER-03)
A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
Chugai Pharmaceutical Co., Ltd.
1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
+81-120-189-706
clinical-trials@chugai-pharm.co.jp
Chugai Pharmaceutical Co., Ltd.
1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo
+81-120-189-706
clinical-trials@chugai-pharm.co.jp
completed
Sept. 25, 2020
800
Interventional
Randomized, Open-Label
treatment purpose
3
- 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 (CRT)
- At least two prior cycles of platinum-based chemotherapy concurrent with radiotherapy (cCRT), which must be completed within 1 to 42 days prior to randomization in the study
- 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)
- No progression during or following concurrent platinum-based CRT
- Tumor PD-L1 expression
- Life expectancy >/= 12 weeks
- Adequate hematologic and end-organ function
- Any history of prior NSCLC
- 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 concurrent CRT 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
- 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
18age old over
No limit
Both
Locally Advanced, Unresectable Stage III NSCLC
investigational material(s)
Generic name etc : Tiragolumab
INN of investigational material : Tiragolumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
Generic name etc : Atezolizumab
INN of investigational material : Atezolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
control material(s)
Generic name etc : Durvalumab
INN of investigational material : Durvalumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 10 mg/kg every 2 weeks (Q2W) will be administered IV on Days 1 and 15 of each 28-day cycle.
