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A Phase 2 Study of MPDL3280A (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.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01846416
First received: May 1, 2013
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This multicenter, single-arm study will evaluate the efficacy and safety of MPDL 3280A in patients with PD-L1-positive locally advanced or metastatic non-small c ell lung cancer (NSCLC). Patients will receive an intravenous dose of 1200 mg MP DL3280A on Day 1 of 21-day cycles until disease progression.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: MPDL3280A
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 MPDL3280A [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Serum MPDL3280A maximum serum concentration [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Serum MPDL3280A 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: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MPDL3280A Single Arm Drug: MPDL3280A
1200 mg intravenously on Day 1 of 21-day cycles until disease progression

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846416

  Hide Study Locations
Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Palo Alto, California, United States, 94304
Santa Monica, California, United States, 90025
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Orlando, Florida, United States, 32904
Port Saint Lucie, Florida, United States, 34952
St.Petersburg, Florida, United States, 33705
Tampa, Florida, United States, 33612
United States, Georgia
Carrolton, Georgia, United States, 30117
United States, Illinois
Chicago, Illinois, United States, 60637
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New York
New York, New York, United States, 10065
United States, North Carolina
Durham, North Carolina, United States, 27710
Huntersville, North Carolina, United States, 28078
United States, Ohio
Columbus, Ohio, United States, 43210-1250
Hamilton, Ohio, United States, 45103
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Richmond, Virginia, United States, 23230
United States, Washington
Seattle, Washington, United States, 98195
Belgium
Wilrijk, Belgium, 2610
France
Lyon, France, 69008
Netherlands
Amsterdam, Netherlands, 1066 CX
United Kingdom
London, United Kingdom, EC1M 6BQ
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

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: November 4, 2014
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
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 19, 2014