A Vaccine Study for Treating Stage IV Non-Small Cell Lung Cancer

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT05242965

Provider View

This clinical trial is testing a new vaccine called STEMVAC to see if it can help shrink tumors in patients with advanced non-small cell lung cancer. The vaccine works by targeting specific proteins that help cancer cells grow, and it's given along with a substance to boost the immune response.

Patient Parameters

Program Overview

This study is exploring whether a new vaccine, STEMVAC, can help reduce tumors in patients with stage IV non-small cell lung cancer. STEMVAC is made from DNA, which is a natural part of all living things and acts like a blueprint for cells. The DNA in this vaccine instructs the body to produce parts of five proteins that are important for cancer growth. The vaccine is given with a substance called GM-CSF to enhance the immune system's ability to fight cancer. The goal is to see if this combination can help the immune system recognize and destroy lung cancer cells while patients are on maintenance therapy.

Description

In this study, patients are divided into two groups:

  • Group 1: Patients receive the STEMVAC vaccine under the skin and a substance called sargramostim on the 14th day of their 21-day treatment cycle. This is done for three doses, followed by a booster dose nine weeks after the third dose. Patients will also have CT scans, biopsies, and blood tests during the study and follow-up.

  • Group 2: Patients receive only sargramostim under the skin on the 14th day of their 21-day treatment cycle, following the same schedule as Group 1. They will also have CT scans, biopsies, and blood tests during the study and follow-up.

After finishing the study treatment, patients will be monitored twice a year for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV non-small cell lung cancer.
  • Have measurable cancer based on specific criteria within one month before the first vaccine.
  • Completed 3-4 cycles of chemoimmunotherapy without the cancer getting worse, including at least three cycles with pembrolizumab.
  • Not received more than two cycles of maintenance therapy with pembrolizumab and/or pemetrexed and can continue this therapy.
  • Have at least one area of cancer that can be biopsied during treatment.
  • At least 28 days since stopping systemic steroids before joining the study, unless used with chemotherapy or to prevent contrast reactions.
  • Have a performance status score of 0 or 1, indicating good overall health.
  • Recovered from major infections or surgeries and have no significant active medical issues.
  • Willing to have up to two biopsies during the study.
  • Expected to live more than six months.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Agree to use contraception during the study.
  • At least 18 years old.

Exclusion Criteria

  • Have certain heart conditions, such as severe heart failure or recent unstable angina.
  • Have untreated brain metastases. Treated brain metastases must be stable for at least four weeks.
  • Have allergies to the study's immune-boosting substance.
  • Have significant autoimmune diseases requiring treatment with immunosuppressants.
  • Have had another invasive cancer within the past two years, unless it was early stage and treated successfully.
  • Enrolled in another treatment study.
  • Pregnant or breastfeeding.
  • Have specific genetic changes in cancer for which there are approved targeted treatments, unless ineligible or have progressed through those treatments.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.