Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05570825

SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer

Led by University of Washington · Updated on 2025-12-04

30

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial tests whether CXCR1/2 inhibitor SX-682 (SX-682) with pembrolizumab works to treat patients with stage IIIC or IV non-small cell lung cancer that has spread to other parts of the body (metastatic) or that has come back (recurrent). SX-682 is a drug that binds to receptors on some types of immune and cancer cells, inhibiting signaling pathways, reducing inflammation, and allowing other types of immune cells to kill and eliminate cancer cells. Pembrolizumab is a monoclonal antibody that binds to a receptor called PD-1 that is found on the surface of T-cells (a type of immune cell), activating an immune response against tumor cells. Giving SX-682 in combination with pembrolizumab may be more effective at treating patients with metastatic or recurrent non-small cell lung cancer than giving these treatments alone.

CONDITIONS

Official Title

SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Diagnosed with non-small cell lung cancer without known EGFR mutation, ALK, ROS1, or RET rearrangements
  • Tumor PD-L1 expression of 1% or higher
  • Metastatic or recurrent non-small cell lung cancer, including stage IIIC if not suitable for surgery or radiation
  • At least one measurable tumor site
  • ECOG performance status of 0 or 1
  • Willing to provide pre-treatment archived specimen or undergo biopsy if no specimen available
  • Willing to provide biopsy during treatment if safe
  • Platelet count of at least 100,000/uL
  • Absolute neutrophil count of at least 1,500/uL
  • Hemoglobin level of 8 g/dL or higher
  • AST and ALT levels no more than 2.5 times the upper limit of normal
  • Creatinine level of 2.0 mg/dL or less
  • Women of childbearing potential and sexually active men must agree to use effective contraception during and for three months after treatment
  • Negative pregnancy test for patients of childbearing potential
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Prior chemotherapy or immune checkpoint inhibitor therapy for metastatic or recurrent NSCLC, except if received more than 24 weeks before consent in the curative setting
  • Presence of other active cancers within the last 2 years, except certain early stage cancers treated definitively
  • Symptomatic or untreated central nervous system metastases
  • Spinal cord compression without prior treatment or unstable symptoms
  • Active autoimmune disease requiring immune-modulating treatment within the past year
  • Inability to stop systemic corticosteroids 7 days before treatment
  • Known primary immunodeficiency or history of organ transplant requiring immunosuppression
  • Current or past immune checkpoint inhibitor-related pneumonitis
  • Recent radiotherapy or major surgery within specified time frames
  • Corrected QT interval over 480 msec on ECG or congenital long QT syndrome
  • Severe lung disease requiring steroids
  • Serious cerebrovascular or cardiac disease including recent heart attack or stroke
  • Active chronic infections such as hepatitis B, C, tuberculosis unless controlled
  • Uncontrolled HIV infection
  • Any serious disorder that would impair ability to complete the study
  • History of non-compliance or inability to provide reliable consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

R

Rebecca Wood

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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