A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m\^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Key facts

Study ID

NCT01903993

Run by

Hoffmann-La Roche

People needed

287

Starts

2013-08-06

Expected to finish

2018-09-06

Last updated by the study team

2019-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult participants, >/= 18 years of age
• Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
• Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
• Measurable disease, as defined by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if…

• Known active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
• History of autoimmune disease
• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Active hepatitis B or hepatitis C
• Prior treatment with docetaxel
• Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Where it is running

• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Kaiser Permanente - San Marcos — San Marcos, California, United States
• Kaiser Permanente - Vallejo — Vallejo, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Rocky Mountain Cancer Centers - Colorado Springs (Circle) — Lone Tree, Colorado, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• New England Cancer Specialists — Scarborough, Maine, United States
• Karmanos Cancer Institute.. — Detroit, Michigan, United States
• Billings Clinic; Research Center — Billings, Montana, United States
• Comprehensive Cancer Centers of Nevada - Eastern Avenue — Las Vegas, Nevada, United States
• The Valley Hospital — Paramus, New Jersey, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• Broome Oncology - Binghamton — Binghamton, New York, United States
• Willamette Valley Cancer Ctr - 520 Country Club — Eugene, Oregon, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Center for Biomedical Research LLC — Knoxville, Tennessee, United States
• Texas Oncology - South Austin — Austin, Texas, United States
• Texas Oncology, P.A. - Fort Worth — Fort Worth, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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