REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)
M.D. Anderson Cancer Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years or older 2. Histologic diagnosis of non-small cell lung cancer 3. Written consent obtained before initiation of any study-related procedures 4. Definitive cancer treatment intent 5. Absence of concurrent malignancies at other sites, except low risk prostate cancer and basal cell of the skin. Participants with prior cancers should not be receiving active cancer treatment within the past 3 months. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 1 year and who are deemed at low ri…
Interventions
- DrugNKTR-255
Given by IV (vein)
- DrugDurvalumab
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas