Study on Restoring Lymphocytes Using NKTR-255 After Chemoradiotherapy in Solid Tumors (RESCUE)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05632809

Provider View

This clinical trial is exploring the effects of a new drug, NKTR-255, combined with the standard drug durvalumab, on patients with locally advanced non-small cell lung cancer (NSCLC) after they have received chemoradiotherapy.

Patient Parameters

Program Overview

The purpose of this study is to investigate how the experimental drug NKTR-255, when used with the standard treatment durvalumab, affects patients with locally advanced non-small cell lung cancer (NSCLC) after they have undergone chemoradiotherapy (CRT). The study aims to see if NKTR-255 can help restore certain immune cells and to monitor its safety, especially regarding lung inflammation.

Description

The main goals of this study are to:

  1. Measure how well NKTR-255 helps restore immune cells, such as lymphocytes, NK cells, and T cells, after chemoradiotherapy when used with durvalumab.
  2. Ensure the safety of NKTR-255, particularly looking for any severe lung inflammation related to the treatment.

Additional goals include:

  1. Estimating how long patients live without the cancer getting worse (progression-free survival).
  2. Estimating the overall survival time of patients.

The study will also explore:

  1. How NKTR-255 is processed in the body and its potential to cause immune reactions.
  2. The effects of NKTR-255 on immune cell activity and growth, and changes in certain proteins in the blood.
  3. The relationship between cancer DNA in the blood and treatment effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer.
  • Provide written consent before starting any study-related procedures.
  • Be receiving treatment with the intent to cure the cancer.
  • Have no other current cancers, except for certain treated skin cancers. Cancer survivors who have been disease-free for 5 years and are at low risk of recurrence can participate.
  • Have adequate liver and kidney function based on specific blood tests.
  • Have an ECOG performance status of 0 to 2, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have HIV or other immune system deficiencies.
  • Have a history of hepatitis B or C, unless successfully treated.
  • Have significant autoimmune diseases or inflammatory conditions like Crohn's disease or ulcerative colitis.
  • Have serious health issues, including active infections needing treatment.
  • Have allergies to any part of the study drug.
  • Have had repeated radiation to the treatment area.
  • Have had major surgery within 4 weeks before joining the study and not fully recovered.
  • Have any condition or previous treatment that might affect the study results or the patient's well-being.
  • Have been part of this study before.
  • Be pregnant or have a positive pregnancy test before treatment.
  • Have previously received anti-PD-1 or anti-PD-L1 treatments.
  • Have certain types of blood cancers with high numbers of T or NK cells.
  • Have significant lung disease or unresolved lung inflammation from previous treatments.
  • Have severe side effects from previous treatments that have not improved.
  • Have previously received IL-2 or IL-5 treatments.

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