Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 1, 2013
November 4, 2014
May 2013
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01846416 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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"
A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: MPDL3280A
1200 mg intravenously on Day 1 of 21-day cycles until disease progression
Experimental: MPDL3280A Single Arm
Intervention: Drug: MPDL3280A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
128
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Netherlands,   United Kingdom
 
NCT01846416
GO28625, 2013-000177-69
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP