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 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.
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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