Study on SX-682 and Pembrolizumab for Treating Advanced or Returning Non-Small Cell Lung Cancer

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05570825

Provider View

This clinical trial is testing a new combination of drugs, SX-682 and pembrolizumab, to see if they can effectively treat patients with advanced or returning non-small cell lung cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

This study is exploring whether a new drug, SX-682, when used with pembrolizumab, can help treat patients with advanced or returning non-small cell lung cancer (NSCLC) that has spread. SX-682 works by blocking certain signals in cancer and immune cells, reducing inflammation, and helping the immune system attack cancer cells. Pembrolizumab is an antibody that activates the immune system to fight cancer. The combination of these two drugs may be more effective than using them separately.

Description

In this study, patients will take SX-682 by mouth twice a day, starting a week before receiving pembrolizumab. Pembrolizumab will be given through an IV over 30 minutes on the first day of each cycle. These cycles will repeat every three weeks for up to two years, as long as the cancer does not progress and side effects are manageable. Patients will also have biopsies and scans like PET/CT or MRI at the start and during the study, and blood samples will be collected throughout the study and follow-up period. After finishing the treatment, patients will be monitored for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer without certain genetic mutations.
  • Cancer must express a specific marker (PD-L1) at a level of 1% or higher.
  • Cancer must be advanced (stage IIIC or IV) or have returned and cannot be treated with surgery or radiation.
  • Must have at least one measurable tumor.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must be willing to provide a tumor sample before treatment and during the study.
  • Must have adequate blood cell counts and organ function.
  • Women of childbearing potential and sexually active men must use effective contraception during and after treatment.
  • Must have a negative pregnancy test if applicable.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Have received prior chemotherapy or immune therapy for advanced or returning cancer, unless it was completed over six months ago.
  • Have another active cancer within the last two years, except for certain early-stage cancers.
  • Have symptomatic brain metastases or require steroids for brain metastases.
  • Have active autoimmune diseases requiring treatment in the past year.
  • Cannot stop taking systemic steroids before starting the study.
  • Have a history of organ transplant requiring immunosuppressive drugs.
  • Have current or past lung inflammation related to immune therapy.
  • Have had recent major surgery or radiation therapy.
  • Have certain heart or lung conditions.
  • Have active infections like hepatitis B, C, or tuberculosis.
  • Have uncontrolled HIV infection.
  • Have any other serious medical conditions that could interfere with the study.
  • Have a history of not following medical advice or cannot provide informed consent.

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