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

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What is this study about?

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.

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.

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.

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**.

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.

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.

6 progress evaluation

Your progress will be evaluated using criteria to measure tumor response. This helps determine how well the treatment is working.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Vestre Viken HF Drammen Norway
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
Sykehuset Innlandet HF Brumunddal Norway
Helse Forde HF Foerde Norway
Hjgfo Nnjggtuvdjrurh He Levanger Norway
Apupxadc Ufiduhmvsd Huojcvxj Lorenskog Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not recruiting
15.03.2022

Trial locations

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.

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.

Trial ID:
2022-502437-25-00
NCT ID:
NCT05344209
Trial Phase:
Therapeutic exploratory (Phase II)

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