Restoring immune cells after chemotherapy in lung cancer patients

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

This study is testing a new drug combination to see if it can help lung cancer patients recover their immune cells after chemotherapy and improve their overall health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: radiation, durvalumab
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05632809 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of the investigational drug NKTR-255 in combination with durvalumab on patients with locally advanced non-small cell lung cancer (NSCLC) following chemoradiation therapy. The primary objective is to estimate the restoration of lymphocytes and monitor the safety of NKTR-255, particularly concerning treatment-related complications. Secondary objectives include assessing progression-free and overall survival times, while exploratory objectives focus on pharmacokinetics, immunogenicity, and the correlation between circulating tumor DNA and treatment efficacy. The study aims to provide insights into the immune response and potential benefits of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a histologic diagnosis of non-small cell lung cancer who are undergoing definitive treatment.

Not a fit: Patients with concurrent malignancies or significant immune deficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance immune recovery and improve survival outcomes for lung cancer patients after chemoradiation.

How similar studies have performed: Other studies have shown promise in using immune-modulating therapies in conjunction with standard treatments for lung cancer, suggesting potential for success in this approach.

Eligibility criteria

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 risk for recurrence are eligible for the study.
6. Adequate liver (AST, ALT, Alk Phos, and Tbili \<2 fold upper limit) and kidney function (Cr \< 2.5 limit of normal and Cr clearance \>30)
7. ECOG 0-2

Exclusion Criteria:

Subjects are to be excluded from the study if any of the following conditions apply:

1. HIV infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies
2. Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response);
3. History of clinically significant autoimmune disease, Crohn's disease, ulcerative colitis, or inflammatory disease.
4. Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the Investigator.
5. Known or suspected hypersensitivity to any component of the investigational product
6. Recurrent radiation to the treatment site
7. Prior major surgery within 4 weeks of enrollment from which the patient has not recovered
8. Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results
9. Previous enrollment in this study
10. Pregnancy: a female subject defined as a WOCBP who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
11. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
12. Patients must be capable of understanding and providing a written informed consent.
13. Patients with leukemias or lymphomas with T cell/histiocyte or NK cell rich component(s) and other variants not otherwise specified that contain high numbers of T or NK cells.
14. Evidence of clinically significant interstitial lung disease or active noninfectious pneumonitis during the course of chemoradiation that is unresolved to ≤ grade 1.
15. Patients with grade 4 toxicities during chemoradiation not resolved to grade ≤ 1 by the end of chemoradiation.
16. Prior exposure to IL-2 or IL-5.

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Steven Lin, MD — M.D. Anderson Cancer Center
• Study coordinator: Steven H. Lin, MD

Conditions Lung Cancer