NCT05632809

REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	NKTR-255	Given by IV (vein)
DRUG	Durvalumab	Given by IV (vein)

Timeline

• Start date: 2023-01-10
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2022-12-01
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study