Lung Cancer Clinical Trial
Official title:
REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)
To learn about the effects of the investigational drug NKTR-255 in combination with the standard drug durvalumab on locally advanced NSCLC when given after CRT.
Primary Objectives: 1. Estimate the level of lymphocyte restoration after administration of NKTR-255 concurrently with durvalumab after chemoradiation. Absolute lymphocyte will be obtained along with changes in levels of NK cells, CD4 T cells, CD8 T cells, and B cells from baseline. 2. Monitor the safety of NKTR-255, which includes treatment related grade 3+ radiation pneumonitis Secondary Objectives: 1. Estimate the Progression-free survival time distribution 2. Estimate the Overall survival time distribution Exploratory objectives: 1. Characterize pharmacokinetics of NKTR-255 and assess immunogenicity of NKTR-255 2. Characterize pharmacodynamic effects and changes in activation markers and proliferation of NK and CD8 T cells, and cytokine levels after administration of NKTR-255 in combination with Durvalumab 3. Assess the correlation between ctDNA and efficacy measurements ;
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