Trial information

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"

Status:
Active, not recruiting
Protocol number:
GO28625
Sponsor:
Genentech
Company division:
Pharmaceutical
Product name:
MPDL3280A
Official Scientific 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
Brief summary:
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 until disease progression. Target sample size is 128.
Study phase:
II
Study type:
Interventional; Treatment; Non-randomized; Open label; Single group; Safety/efficacy study
Conditions:
  • Non-Small Cell Lung Cancer
Primary outcome:
  1. Objective response as assessed by the investigator according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Time frame: Approximately 5 years
Key secondary outcomes:
  1. Objective response according to standard RECIST v1.1 Time frame: Approximately 5 years
  2. Duration of response according to standard RECIST v1.1 Time frame: Approximately 5 years
  3. Progression-free survival according to standard RECIST v1.1 Time frame: Approximately 5 years
  4. Progression-free survival according to modified RECIST Time frame: Approximately 5 years
  5. Duration of response according to modified RECIST Time frame: Approximately 5 years
  6. Safety: Incidence of adverse events Time frame: Approximately 5 years
  7. Safety: Incidence of anti-therapeutic antibodies against MPDL3280A Time frame: Approximately 5 years
  8. Pharmacokinetics: Serum MPDL3280A maximum serum concentration Time frame: Day 1 of Cycle 1
  9. Pharmacokinetics: Serum MPDL3280A minimum serum concentration Time frame: Day 1 of Cycles 2, 4, and 8 and at study termination
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
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
May, 2013
Trial registration date:
22.04.2013
Date last updated:
16.12.2014
This trial was conducted at the following locations:
BELGIUM
  • Wilrijk
FRANCE
  • Lyon
  • Villejuif
GERMANY
  • Essen
  • GROSSHANSDORF
ITALY
  • ORBASSANO, Piemo
NETHERLANDS
  • AMSTERDAM
SPAIN
  • Barcelona, BARCE
  • SEVILLA, SEVIL
SWITZERLAND
  • Lausanne
  • Zürich
UNITED KINGDOM
  • BRIGHTON
  • London
UNITED STATES
  • Scottsdale, AZ
  • Palo Alto, CA
  • Santa Monica, CA
  • Aurora, CO
  • New Haven, CT
  • WASHINGTON, DC
  • Orlando, FL
  • PORT SAINT LUCIE, FL
  • St.Petersburg, FL
  • TAMPA, FL
  • Carrolton, GA
  • Chicago, IL
  • Boston, MA
  • Baltimore, MD
  • Durham, NC
  • Huntersville, NC
  • Lebanon, NH
  • New York, NY
  • COLUMBUS, OH
  • Hamilton, OH
  • Hershey, PA
  • Philadelphia, PA
  • Pittsburgh, PA
  • Nashville, TN
  • Houston, TX
  • Salt Lake City, UT
  • Richmond, VA
  • Seattle, WA

Link to trial result

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