Is NCT05242965 recruiting in Seattle, WA?

Yes, NCT05242965 is currently recruiting participants at its Seattle, WA location. This lung non-small cell carcinoma clinical trial is actively enrolling qualified participants.

How do I join the lung non-small cell carcinoma clinical trial in Seattle?

To join this clinical trial in Seattle, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Seattle clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lung Non-Small Cell Carcinoma Clinical Trial in Seattle, WA

About This Lung Non-Small Cell Carcinoma Study in Seattle

This phase II trial tests whether CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine (STEMVAC) works to shrink tumors in patients with stage IV non-small cell lung cancer. STEMVAC targets specific immunogenic proteins that help lung cancer cells to grow. STEMVAC is made up of deoxyribonucleic acid (DNA), which is a natural substance in every living organism. DNA acts like a blueprint that tells all the cells in your body how to function. The DNA used in this study contains instructions for your body to produce parts of the 5 proteins the investigators identified (CDH3, CD105, YB-1, MDM2 and SOX2). STEMVAC is given with granulocyte-macrophage colony stimulating factor (GM-CSF) which is being used as an adjuvant to help create a stronger immune response. Giving STEMVAC with GM-CSF to patients while on maintenance therapy for non-small cell lung cancer (NSCLC) may help activate certain immune cells to recognize and kill lung cancer cells.

Sponsor: University of Washington

Who Can Participate

Inclusion Criteria

Histologically-confirmed diagnosis of stage IV non-squamous or squamous NSCLC.

Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within one month of first vaccine. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

Have completed 3-4 cycles of chemoimmunotherapy, without evidence of progressive disease. Pembrolizumab has to be included in at least 3 of these cycles.

Have not received more than 2 cycles of maintenance pembrolizumab and/or pemetrexed and be a candidate for continuation of this therapy.

At least 1 site of disease that could be biopsied during treatment. This site should not be a site that is used to determine measurable disease for efficacy purposes. Lesions that will be biopsied should not be on a previously irradiated area unless progression has been demonstrated in such lesions.

Patients must be at least 28 days post systemic steroids prior to enrollment, unless this is a steroid administered concurrently with chemotherapy or used as part of prophylaxis to prevent intravenous (IV) contrast reactions.

Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

Patients must have recovered from major infections and/or surgical procedures, and in the opinion of a principle investigator (PI)/co-PI/study physician/physician extender, not have any significant active concurrent medical illnesses precluding protocol treatment.

Willing to undergo up to two serial biopsies while on study.

Estimated life expectancy of more than 6 months.

White blood cells (WBC) \>= 3000/mm\^3 (within 60 days of first vaccination).

Lymphocyte count \>= 800/mm\^3 (within 60 days of first vaccination).

Platelet count \>= 75,000/mm\^3 (within 60 days of first vaccination).

Hemoglobin (Hgb) \>= 9 g/dl (within 60 days of first vaccination).

Serum creatinine =\< 1.2 mg/dl or creatinine clearance \> 50 ml/min (within 60 days of first vaccination).

Total bilirubin =\< 1.5 mg/dl (within 60 days of first vaccination).

Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) =\< 2 times upper limit of normal (ULN) or SGOT =\< 5 times upper limit of normal (ULN) in the presence of liver metastasis (within 60 days of first vaccination).

If female of childbearing potential has a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.

All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study.

Patients must be at least 18 years of age.

Exclusion Criteria

Patients with any of the following cardiac conditions:

Symptomatic restrictive cardiomyopathy

Unstable angina within 4 months prior to enrollment

New York Heart Association functional class III-IV heart failure on active treatment

Symptomatic pericardial effusion

Patients with central nervous system (CNS) metastasis that have not been treated. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids for 2 weeks prior to dosing with study medication.

Patients with any contraindication to receiving recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) based products.

Patients with any clinically significant autoimmune disease that requires active treatment with immunosuppressants. Replacement therapy (e.g., thyroxine, insulin) is not considered a form of systemic treatment. Administration of systemic steroids (i.e., for allergic reactions, computed tomography (CT) scans, or the management of immune related adverse events \[irAEs\]) is allowed.

Has a known history of another prior invasive malignancy within 2 years, except subjects with early stage cancer that has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy.

Patients who are simultaneously enrolled in any other treatment study.

Patients who are pregnant or breastfeeding.

Patients with genetic driver alterations (e.g EGFR, ALK, ROS1, BRAF, MET ex 14, RET) for which targeted treatment exist and are Food and Drug Association (FDA) approved, except if the subject is not eligible or has progressed through those therapies.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Seattle?

Yes, this clinical trial (NCT05242965) has an active research site in Seattle, WA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lung Non-Small Cell Carcinoma Treatment Options in Seattle, WA

If you're searching for lung non-small cell carcinoma treatment options in Seattle, WA, this clinical trial (NCT05242965) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Seattle research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced lung non-small cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lung non-small cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Lung Non-Small Cell Carcinoma Clinical Trial in Seattle, WA

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