Atezolizumab Adjuvant phase 3 study in Lung Cancer [IMpower010]

A Phase III, Open-label, Randomized Study to Investigate the Efficacy and Safety of atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223090

Enrollment

1127

Registered

2016-02-02

Start date

2016-05-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : Atezolizumab INN of investigational material : atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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 </= 84 days) prior to enrollment and must be adequately recovered from surgery -Adequate hematologic and end-organ function

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

Measure	Time frame
efficacy Disease-Free Survival (DFS)	—

Secondary

Measure	Time frame
efficacy Overall Survival (OS)	—

Countries

Australia, Belgium, Canada, China, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026