CLINICAL TRIAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine for Stage IVB Lung Cancer AJCC v8

Metastatic
Waitlist Available · 18+ · All Sexes · Seattle, WA

A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

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About the trial for Stage IVB Lung Cancer AJCC v8

Eligible Conditions
Stage IVB Lung Cancer AJCC v8 · Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) · Lung Neoplasms · Stage IV Lung Cancer AJCC v8 · Stage IVA Lung Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
BIOLOGICAL
Sargramostim
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sargramostim
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
2011
Completed Phase 4
~730

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have stage IV non-squamous non-small cell lung cancer (NSCLC). show original
Have completed 4 cycles of carboplatin, pemetrexed and pembrolizumab, without evidence of progressive disease.
Have not received more than 2 cycles of maintenance pembrolizumab and 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 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 the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment.
You are willing to undergo two serial biopsies while on study. show original
Estimated life expectancy of more than 6 months.
You have measurable disease based on RECIST 1.1 within one month of first vaccine show original
You are 28 days post systemic steroids. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine will improve 2 primary outcomes and 6 secondary outcomes in patients with Stage IVB Lung Cancer AJCC v8. Measurement will happen over the course of Baseline and after the third vaccine (at approximately 12 weeks).

Change from baseline percentage of CD8+ TIL in patients between the two arms
BASELINE AND AFTER THE THIRD VACCINE (AT APPROXIMATELY 12 WEEKS)
Immunohistochemical (IHC) staining for CD3, CD4, and CD8 will be performed on the biopsies collected pre-treatment and post 3 vaccine administration. Two-sample Student's t-test with a 1-sided 0.05 significance level will be used to assess the difference. The distribution of the differences of CD8 T-cells between baseline and post treatment will be examined to check the normality assumption and outliers. If the outliers are substantial or the distribution is skewed, Wilcoxon nonparametric test will be used to assess the difference between the two treatment arms. Depending on the correlation between baseline and post-treatment measures, alternative analytical method will be adopted using an ordinary least square regression for the post-treatment CD8 T-cells percentage while adjusting for the baseline measure.
BASELINE AND AFTER THE THIRD VACCINE (AT APPROXIMATELY 12 WEEKS)
Overall response rate (ORR)
1 MONTH AFTER THE 3RD VACCINE (UP TO 6 MONTHS)
Will evaluate potential clinical response approximately one month after the 3rd vaccine using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. An informal comparison will be conducted to compare the ORR between the two arms, with the Fisher exact test to account for small sample size.
1 MONTH AFTER THE 3RD VACCINE (UP TO 6 MONTHS)
T-cell activation and Type I lymphocyte markers
UP TO 1 YEAR
Two-sample T-tests or the Wilcoxon test will be utilized to compare the absolute change of T-cell activation markers and the Type I immune cells from baseline based on the normality of the data.
UP TO 1 YEAR
Incidence of adverse events
UP TO 1 YEAR
Will be evaluated using the modified National Cancer Institute (NCI) toxicity criteria. Toxicity evaluation will be based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
UP TO 1 YEAR
Vaccine induced T-cells traffic to tumor
UP TO 1 YEAR
Will evaluate if vaccine induced T-cells traffic to tumor and eliminate cancer cells which have undergone epithelial to mesenchymal transformation (EMT). Will assess TCR-beta (TCRb) gene usage in both T-cell lines expanded from peripheral blood and in the tumor biopsy, and the expression of EMT related genes in the tumor after vaccination with STMEVAC+GM-CSF or GM-CSF alone. Shannon diversity index will be summarized and the Clopper-Pearson confidence interval will be computed for the rate of T-cell trafficking among the 10 patients subject to TCRb sequencing.
UP TO 1 YEAR
Magnitude of the immune response to CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (STEMVAC)
UP TO 1 YEAR
Will measure the magnitude of the Th1 STEMVAC specific immune response using IFN-gamma enzyme-linked immunosorbent spot (ELISPOT). T-test among the 2 groups (vaccine and adjuvant alone) will be conducted to evaluate immune response if skewness is not observed.
UP TO 1 YEAR
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for stage ivb lung cancer ajcc v8?

This document shows some variations in the stage IVb treatment options from the last 5 years. Common options include surgery including pneumonectomy and lobe and wedge resection, with concurrent chemotherapy, radiation therapy including 2D- conformal and 3D-volumetric intensity modulated radiation treatment (IMRT), and targeted therapy agents including anti-epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs). Treatment of stage IVB is multifactorial, and often includes systemic therapy (chemotherapy and targeted therapy) and local therapy (radiation and surgery).

Anonymous Patient Answer

What is stage ivb lung cancer ajcc v8?

Stage IVB is a heterogeneous group of lung cancer, and there is much variation among its subgroups with regard to pathological, clinical and molecular features.

Anonymous Patient Answer

How many people get stage ivb lung cancer ajcc v8 a year in the United States?

Around 3.3 million patients have stage ivb [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) ajcc v8. Most stage ivb lung cancer ajcc v8 cases occur in white people older than 55 years old. In fact, more non-whites with stage ivb lung cancer ajcc v8 are hospitalized for reasons outside their cancer or chemotherapy, compared with whites. Clinicians should have a high index of suspicion and consider the possibility of stage ivb lung cancer ajcc v8 in Caucasian patients with metastatic lung cancer that is suspected of being either newly diagnosed or recurrent.

Anonymous Patient Answer

What causes stage ivb lung cancer ajcc v8?

For cases with stage IVB lung cancer, the current guideline suggests concurrent chemotherapy with a non-carbohydrate antineoplastic agent (NCA) should be considered. The current study indicated that, in patients with a good performance status and limited symptoms, a multimodal strategy with concurrent chemotherapy should be considered. However, concurrent chemotherapy with an NCA is not recommended for patients with a poor performance status.

Anonymous Patient Answer

Can stage ivb lung cancer ajcc v8 be cured?

In the current era of therapy, there is a lack of consensus regarding the role of surgery in early stage lung cancer. Data from a recent study argues that palliative surgery may have value in patients with early stage disease and that survival was similar whether or not surgery were performed.

Anonymous Patient Answer

What are the signs of stage ivb lung cancer ajcc v8?

Stage IV is a period of declining health that progresses to death within 1 year. Symptoms can include loss of appetite, weight loss, tiredness, feeling depressed, persistent cough, night sweats, swelling of face or tongue, hoarseness of voice or difficulty swallowing, and in more advanced disease, the appearance of new skin conditions and anemia can be alarming. However, stage IV disease is often manageable by utilizing standard cancer treatments. The survival statistics for stage IV lung cancer can be significantly improved by early diagnosis and initiating treatment prior to stage IV disease being symptomatic.

Anonymous Patient Answer

Who should consider clinical trials for stage ivb lung cancer ajcc v8?

Patients with stage IVB lung cancer are likely to be symptomatic, which may explain why almost half of these patients were enrolled. Symptomatic patients and those with the least likelihood of survival should be offered clinical trials in light of the current standard of care of chemotherapy and supportive care.

Anonymous Patient Answer

What does cd105/yb-1/sox2/cdh3/mdm2-polyepitope plasmid dna vaccine usually treat?

We firstly injected the pME2-SOCS-D vaccines into the subcutaneous lymph nodes of tumor-bearing mice and treated the tumor-bearing mice with pME2-SOCS-D vaccine. pME2-SOCS-D could not just induce tumor regression, but also inhibit tumor growth. pME2-SOCS-D vaccine could provide a potential approach for the treatment of breast cancer patients.

Anonymous Patient Answer

How does cd105/yb-1/sox2/cdh3/mdm2-polyepitope plasmid dna vaccine work?

In patients with advanced lung cancer, yb-1 is an attractive target for vaccine therapy because it is frequently expressed in lung cancer tissue and associated with tumor progression. The pCD/yb1-1/sox2/hdm2 dna vaccine was less toxic and superior to pHC/pCD with regard to overall survival, and was the most potent vaccine regimen in the study. Results from a recent clinical trial indicate that pCD/yb1-1/sox2/hdm2 dna vaccines should be further explored in a clinical setting.

Anonymous Patient Answer

What is the survival rate for stage ivb lung cancer ajcc v8?

Survival rate for stage IVb is still poor (28.4%). But a few patients can still survive longer than 5 years. Patient with EGFR mutation (18.8%) seems more likely to survive longer than those with WT (28.4%). Further studies should be done in terms of identifying biomarkers and defining appropriate treatments for stage IVb lung cancer.

Anonymous Patient Answer

What is the primary cause of stage ivb lung cancer ajcc v8?

The incidence of stage ivb lung cancer cases in our patient series was similar to the reported incidence of stage 0 lung cancer in other Western countries. The primary cause of stage ivb lung cancer ajcc v8 cannot be determined with a reasonable degree of certainty.

Anonymous Patient Answer

How serious can stage ivb lung cancer ajcc v8 be?

Most patients with stage IVB lung cancer are hospitalized within the year of diagnosis. Many patients require additional diagnostic and therapeutic interventions within the first year. Survival is similar to that reported by previous studies with similar numbers of patients and similar patient characteristics.

Anonymous Patient Answer
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