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A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer


Inclusion Criteria:



- Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent
non-small cell lung cancer (NSCLC)

- PD-L1-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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response as assessed by the investigator according to modified Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Approximately 5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO28625

NCT ID:

NCT01846416

Start Date:

May 2013

Completion Date:

May 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Lebanon, New Hampshire  
Salt Lake City, Utah  84112