A Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer - "FIR"

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
First received: May 1, 2013
Last updated: May 4, 2016
Last verified: May 2016
This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients will receive an intravenous dose of 1200 mg Atezolizumab on Day 1 of 21-day cycles until disease progression.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Atezolizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Objective response as assessed by the investigator according to modified Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response according to standard RECIST v1.1 [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Duration of response according to standard RECIST v1.1 [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival according to standard RECIST v1.1 [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival according to modified RECIST [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Duration of response according to modified RECIST [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of anti-therapeutic antibodies against atezolizumab [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Serum atezolizumab maximum serum concentration [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Serum atezolizumab minimum serum concentration [ Time Frame: Day 1 of Cycles 2, 4, and 8 and at study termination ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: May 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab Single Arm Drug: Atezolizumab
1200 mg intravenously on Day 1 of 21-day cycles until disease progression


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent non-small cell lung cancer (NSCLC)
  • PDL1-positive status as determined by an IHC assay performed by a central laboratory
  • ECOG Performance Status of 0 or 1
  • Life expectancy >= 12 weeks
  • Measurable disease, as defined by RECIST v1.1
  • 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 Tyrosine kinase inhibitors approved for treatment of NSCLC discontinued > 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 CNS disease, including treated brain metastases: Cohorts 1 and 2
  • Patients with a history of treated asymptomatic brain metastases are allowed in Cohort 3
  • Leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01846416

  Show 29 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01846416     History of Changes
Other Study ID Numbers: GO28625  2013-000177-69 
Study First Received: May 1, 2013
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on May 26, 2016