Not recruiting

Study on the Effectiveness and Safety of UV1 Vaccine with or without Sargramostim for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), which is advanced or has spread to other parts of the body. The study is investigating the effects of a treatment that includes a combination of a PD-1/PD-L1 inhibitor and a vaccine called UV1. The PD-1/PD-L1 inhibitor is a type of medication that helps the immune system recognize and attack cancer cells. The UV1 vaccine is designed to stimulate the immune system to target cancer cells more effectively.

The purpose of the study is to evaluate and compare the effectiveness of the PD-1/PD-L1 inhibitor treatment with or without the addition of the UV1 vaccine in patients with advanced stages of NSCLC. Participants in the study will receive either the PD-1/PD-L1 inhibitor alone or in combination with the UV1 vaccine. The study will monitor the participants over a period to assess how well the treatments work and to ensure their safety.

Throughout the study, participants will receive the treatments as an injection under the skin, known as intradermal use. The study aims to gather information on how long patients live without the cancer getting worse, known as progression-free survival, as well as other outcomes like overall survival and response to treatment. The study is expected to continue until 2027, providing valuable insights into the potential benefits of combining the UV1 vaccine with standard cancer treatments.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking your medical history and performing necessary tests to ensure you meet the study criteria.
Step 3
Treatment assignment
You will be randomly assigned to one of two groups. One group will receive a **PD-1/PD-L1 inhibitor** treatment alone, and the other group will receive the same treatment plus the **UV1 vaccination**.
Step 4
Treatment administration
If you are in the group receiving the **UV1 vaccination**, it will be administered through an injection into the skin (intradermal use). The exact dosage and frequency will be determined by the study protocol.
The **PD-1/PD-L1 inhibitor** will be administered according to standard medical practice for your condition.
Step 5
Regular monitoring
Throughout the study, regular monitoring will occur. This includes scheduled visits for physical exams, blood tests, and imaging studies to assess your response to the treatment.
Step 6
Progress evaluation
Your progress will be evaluated using criteria to measure tumor response. This helps determine how well the treatment is working.
Step 7
End of treatment
At the end of the treatment period, a final assessment will be conducted. This includes a comprehensive evaluation of your health and the effectiveness of the treatment.
Step 8
Follow-up
After completing the treatment, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment.

Who can join the trial?

15 criteria

You must have a type of lung cancer called advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be cured with surgery or other treatments.
Your cancer must be at stage IIIB, IIIC, or IV, and it should have a specific marker called PD-L1 that is 50% or higher, which is measured by a special test.
You should be eligible to receive a type of treatment called PD-1/PD-L1 inhibitor monotherapy as your first treatment.
You must have at least one cancer spot that has not been treated with radiation and can be measured accurately.
If you had previous cancer treatments before surgery or after surgery (but not immunotherapies), you can join if it has been at least 12 months since those treatments ended and your cancer spread.
You need to provide a sample of your tumor tissue, either as slides or a block, for analysis.
You must be at least 18 years old.
Your general health should be good enough to perform daily activities, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, which should be between 0 and 2.
Your organs should be working well, which includes having:
- Hemoglobin levels of at least 9.0 g/dL (a measure of red blood cells).
- Absolute neutrophil count (ANC) of more than 1500 per mm³ (a type of white blood cell).
- Platelet count of more than 75,000 per mm³ (cells that help with blood clotting).
- Serum bilirubin levels no more than 1.5 times the normal limit (a substance made by the liver).
- AST (SGOT)/ALT (SGPT) levels no more than 2.5 times the normal limit, unless you have liver cancer spread, in which case it should be no more than 5 times the normal limit (enzymes that show liver function).
- Creatinine clearance greater than 40 mL/min, which shows how well your kidneys are working.
- You must agree to participate by signing a document called an informed consent form before any study procedures begin.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than advanced or metastatic non-small cell lung cancer cannot participate.
Patients who are not in the age range specified for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who have previously received certain treatments that might interfere with the study cannot participate.
Patients with certain medical conditions that could affect the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have allergies to the study medication or its components cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Akershus University Hospital
Verified
Lorenskog, Norway
Helse Stavanger HF
Verified
Stavanger, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Anti-PD-1/PD-L1 Treatment
is a type of immunotherapy used in cancer treatment. It works by blocking certain proteins on the surface of immune cells, which can help the immune system recognize and attack cancer cells more effectively. This treatment is often used for various types of cancer, including non-small cell lung cancer, to help slow down or stop the growth of cancer cells.
UV1 Vaccination
is a type of cancer vaccine designed to stimulate the body's immune system to fight cancer. It works by introducing specific proteins related to cancer cells into the body, which helps the immune system recognize and target these cancer cells. This vaccine is being studied to see if it can enhance the effects of other cancer treatments, like the anti-PD-1/PD-L1 treatment, in patients with advanced or metastatic non-small cell lung cancer.

What is already known about the treatment

PD-1/PD-L1 Inhibitor
This medication is administered intravenously, meaning it is given through a vein, usually in the arm. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be surgically removed. The main therapeutic use of this medication is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking the PD-1 or PD-L1 proteins, which are used by cancer cells to hide from the immune system. This medication is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.
UV1 Vaccine
This vaccine is administered through an injection, typically into the skin or muscle. It is being tested in clinical trials to see if it can enhance the effects of PD-1/PD-L1 inhibitors in treating advanced or metastatic non-small cell lung cancer. The main purpose of the UV1 vaccine is to stimulate the immune system to better recognize and attack cancer cells. It works by introducing specific proteins that trigger an immune response against the cancer. This vaccine is classified as a therapeutic cancer vaccine, designed to boost the body's natural defenses against cancer.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can invade nearby tissues and spread to other parts of the body, a process known as metastasis. In its advanced stages, NSCLC may cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some cases remaining localized for a period before spreading, while others may advance more rapidly. The disease is often diagnosed at an advanced stage due to the subtlety of early symptoms.