SCCA Clinical Studies: Lung Cancer
|Closed||Non-Small Cell Lung Cancer||Phase II||
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.
- 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
- 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
Other exclusion criteria may apply.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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