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 - "BIRCH"

Status: Recruiting
Phase:
Diagnosis: Lung Cancer
NCT ID: NCT02031458 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-182

 

This multicenter, single- arm study will evaluate the efficacy and safety of MPD L3280A in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer. Patients will receive MPDL3280A 1200 mg intravenously every 3 weeks for a maximum of 16 cycles (or 12 months, whichever occurs first) in the a bsence of unacceptable toxicity or symptomatic deterioration attributed to disea se progression. Patients who complete the initial treatment stage may be eligibl e fro MPDL3280A re-treatment upon subsequent disease progression during the foll ow-up period without intervening systemic anti-cancer therapy.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Mark Huberman, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Pasi Janne, MD, PhD, Dana-Farber Cancer Institute
Rebecca Heist, MD, Massachusetts General Hospital

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Adult patients, >/= 18 years of age - Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) - Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens - PD-L1-positive tumor status as determined by an IHC assay performed by a central laboratory - Measurable disease, as defined by RECIST v1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed: Hormone-replacement therapy or oral contraceptives TKIs approved for treatment of NSLC discontinued > 7 days prior to Cycle 1, Day 1 - Central nervous system (CNS) disease, including treated brain metastases. - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome - History of autoimmune disease - History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted. - Active hepatitis B or hepatitis C - HIV positive - Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
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