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 currently recruiting participants.
Verified April 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01846416
First received: May 1, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This multicenter, single-arm study will evaluate the efficacy and safety of MPDL3280A 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 MPDL3280A on Day 1 of 21-day cycles for a maximum of 16 cycles.


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:

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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival according to modified Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Duration of response according to modified Response Evaluation Criteria in Solid Tumors (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 ]

Estimated Enrollment: 130
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 for a maximum of 16 cycles.

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

Contacts
Contact: Reference Study ID Number: GO28625 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Arizona
Active, not recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Recruiting
Palo Alto, California, United States, 94304
Recruiting
Santa Monica, California, United States, 90025
United States, Colorado
Completed
Aurora, Colorado, United States, 80045
United States, Connecticut
Recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Active, not recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Active, not recruiting
Orlando, Florida, United States, 32904
Active, not recruiting
Port Saint Lucie, Florida, United States, 34952
Active, not recruiting
St.Petersburg, Florida, United States, 33705
Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Not yet recruiting
Atlanta, Georgia, United States, 30322
Active, not recruiting
Carrolton, Georgia, United States, 30117
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60637
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Recruiting
New York, New York, United States, 10065
United States, North Carolina
Recruiting
Durham, North Carolina, United States, 27710
Active, not recruiting
Huntersville, North Carolina, United States, 28078
United States, Ohio
Recruiting
Columbus, Ohio, United States, 43210-1250
Recruiting
Hamilton, Ohio, United States, 45103
United States, Pennsylvania
Recruiting
Hershey, Pennsylvania, United States, 17033
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Not yet recruiting
Dallas, Texas, United States, 75235
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84112
United States, Virginia
Recruiting
Richmond, Virginia, United States, 23230
United States, Washington
Active, not recruiting
Seattle, Washington, United States, 98195
Belgium
Recruiting
Wilrijk, Belgium, 2610
France
Recruiting
Lyon, France, 69008
Netherlands
Recruiting
Amsterdam, Netherlands, 1066 CX
United Kingdom
Recruiting
London, United Kingdom, EC1M 6BQ
Recruiting
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01846416     History of Changes
Other Study ID Numbers: GO28625, 2013-000177-69
Study First Received: May 1, 2013
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014