Atezolizumab Adjuvant phase 3 study in Lung Cancer [IMpower010]
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080223090
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1127
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
-Histological or cytological diagnosis of Stage IB (tumors >/= 4 cm) -IIIA (T2-3 N0,T1-3 N1,T1-3 N2,T4 N0) NSCLC
-Patients must have had complete resection of NSCLC 4-12 weeks (>/= 28 days and -Adequate hematologic and end-organ function
-Pregnant and lactating women
-Treatment with prior systemic chemotherapy at any time
-Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
-Prior treatment with CD137 agonists or immune checkpoint blockade therapies,anti-PD-1,and anti-PD-L1 therapeutic antibodies
-Malignancies other than NSCLC within 5 years
-History of autoimmune disease
-Positive test for HIV
-Patients with active hepatitis B or hepatitis C
-Significant cardiovascular disease,
-History of idiopathic pulmonary fibrosis, organizing pneumonia(e.g., bronchiolitis obliterans),drug-induced pneumonitis,idiopathic pneumonitis,or evidence of active pneumonitis on screening chest CT scan
-Prior allogeneic bone marrow transplantation or solid organ transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Disease-Free Survival (DFS)
- Secondary Outcome Measures
Name Time Method efficacy<br>Overall Survival (OS)