CompletedPhase 2NCT01846416

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

This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression. Eligible participants will be categorized in to three groups as follows: 1. Participants with no prior chemotherapy for advanced disease; 2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants); 3. Participants who are 2L+ and previously treated for brain metastases.

Checked against the public recordLast updated Jan 8, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations31
SponsorGenentech, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Genentech, Inc.
Interventions being studied
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC * PDL1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. A positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion * Eastern Cooperative Oncology group Performance Status of 0 or 1 * Life expectancy greater than or equal to 12 weeks * Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 * Adequate hematologic and end organ function Exclusion Criteria: * Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1 * Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment * Known central nervous system disease, including treated brain metastases in the following participants: 1. who will not receive prior chemotherapy for advanced disease 2. who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2L+ participants) * Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases. * Leptomeningeal disease * Uncontrolled tumor-related pain * Uncontrolled hypercalcemia

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • HonorHealth Research Institute - Pima CenterScottsdale, Arizona
  • Stanford University/Lucile Packard Children's HospitalPalo Alto, California
  • The Angeles Clinic and Research Institute, Santa Monica OfficeSanta Monica, California
  • University Of ColoradoAurora, Colorado
  • Yale University School Of MedicineNew Haven, Connecticut
  • Georgetown UniversityWashington D.C., District of Columbia
  • Florida Hospital Cancer InstOrlando, Florida
  • Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
  • Florida Cancer Specialists.St. Petersburg, Florida
  • H. Lee Moffitt Cancer Center and Research Inst.Tampa, Florida
  • Northwest Georgia Oncology Centers P.C.Carrollton, Georgia
  • The University of Chicago Medical CenterChicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 8, 2019. Always confirm current availability with the study team.

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