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

  Show 32 Study Locations
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 16, 2014