A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (BIRCH)

Roche

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Atezolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02031458

2013-003330-32 (EudraCT Number)

GO28754

Details and patient eligibility

About

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Enrollment

667 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult participants greater than or equal to 18 years of age
Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
Measurable disease, as defined by RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:

Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1

Central nervous system (CNS) disease, including treated brain metastases
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
History of autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted
Active hepatitis B or hepatitis C
Human Immunodeficiency virus (HIV) positive
Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents