Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
Phase 2 Trial of TGF-β2 Inhibition (OT-101) With Atezolizumab as Second-Line or Third-Line Therapy for Patients Previously Treated With Immunotherapy (+/- Chemotherapy) With Metastatic Non-Small Cell Lung Cancer (NSCLC)
This phase II trial tests how well trabedersen (OT-101) in combination with atezolizumab works in treating patients with non-small cell lung cancer (NSCLC) that has spread from where it first started (lung) to other places in the body (metastatic) or has come back after a period of improvement (recurrent). OT-101 is a transforming growth factor (TGF)-beta2 specific drug. TGF-beta2, a cytokine that is often overexpressed in various malignant tumors, may play an important role in promoting the growth, progression and migration of tumor cells. OT-101 binds to the TGF-beta2 receptor causing inhibition of protein production, thereby decreasing TGF-beta2 protein levels which may result in the inhibition of tumor cell growth and migration. Atezolizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving OT-101 and atezolizumab together may be an effective treatment for patients with metastatic or recurrent NSCLC.
OUTLINE: Patients receive atezolizumab intravenously (IV) on day 1 and trabedersen continuous IV on days 1-4 and days 15-19 of each cycle. Cycles repeat every 28 days for 104 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and every 8 weeks for the first 24 weeks and then every 12 weeks thereafter. Patients undergo blood sample collection prior to initiation of therapy, on day 4 of cycles 1-4, prior to weeks 4 and 8 of therapy, and at time of progression. Patients may also undergo biopsy during screening and/or 6-8 weeks after initiation of therapy. After completion of study treatment, patients are followed up to 90 days and then every 3 months for up to 60 months. ;
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