Study on the Safety and Effects of PDC*lung01 Vaccine with Pemetrexed or Pembrolizumab for Patients with 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). The study is testing a new treatment called PDC*lung01, which is a therapeutic cancer vaccine. This vaccine is made from special cells called allogeneic plasmacytoid dendritic cells, which are loaded with specific proteins from lung tumors. The vaccine is designed to help the immune system recognize and fight cancer cells. The study will also explore the effects of combining this vaccine with another treatment known as anti-PD-1 therapy, which helps the immune system attack cancer cells more effectively.

The purpose of the study is to assess the safety and tolerability of the PDC*lung01 vaccine when given alone or in combination with other treatments. Participants will receive the vaccine through injections, and the study will monitor how their bodies respond to the treatment. Some participants may also receive additional treatments like pemetrexed, a chemotherapy drug, or pembrolizumab, an anti-PD-1 therapy, depending on their specific condition. The study will observe the effects of these treatments over time to gather information on their safety and potential benefits.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study aims to gather valuable information that could lead to new treatment options for patients with non-small-cell lung cancer. The results will help researchers understand how well the vaccine works and how it can be used in combination with other therapies to improve patient outcomes.

1 Initial treatment phase

The study involves the administration of a therapeutic cancer vaccine called PDC*lung01. This vaccine is designed to target non-small-cell lung cancer (NSCLC).

The vaccine is administered through injection, which can be intravenous, subcutaneous, or intramuscular. The specific route will be determined by the study protocol.

2 Combination treatment phase

Depending on the cohort, PDC*lung01 may be combined with other treatments.

For patients in Cohorts A1 and A2, the vaccine is administered alongside pemetrexed, a chemotherapy drug. Pemetrexed is given as an intravenous infusion.

For patients in Cohorts B1 and B2, the vaccine is administered with pembrolizumab, an anti-PD-1 therapy. Pembrolizumab is also given as an intravenous infusion.

3 Monitoring and assessment

Throughout the study, the safety and tolerability of the treatments are closely monitored. This includes checking for any dose-limiting toxicities and adverse events.

Regular blood tests are conducted to measure immune responses and to monitor for the presence of specific antibodies.

4 Follow-up period

After the last dose of PDC*lung01, patients are monitored for an additional 28 days to assess any delayed reactions or side effects.

The study aims to evaluate the progression-free survival and objective response rate, which are measures of how well the cancer responds to the treatment.

Who Can Join the Study?

The patient must have a specific type of lung cancer called non-small-cell lung cancer.
The patient must be at least 18 years old.
The patient must be able and willing to follow the study requirements, according to the doctor’s opinion.
The patient must be willing and able to sign a consent form before any study procedures begin.
The patient must have a specific genetic marker called HLA-A*02:01 and no antibodies against certain proteins.
The patient must have a good level of daily functioning, known as ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
The patient must have good kidney and liver function, as shown by specific blood test results.
The patient must have good blood health, with enough platelets, white blood cells, and hemoglobin.
The patient must be willing to provide a blood sample for research purposes.
If the patient has cancer that has spread to the brain, it must not be causing symptoms or must be treated and stable.
Female patients who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for a period after.
Male patients must agree to use a condom during the study and for a period after.
For patients in France, they must be part of a health insurance system.

Who Cannot Join the Study?

Patients with other types of cancer besides non-small-cell lung cancer cannot participate. Non-small-cell lung cancer is a type of lung cancer that grows and spreads more slowly than small-cell lung cancer.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have certain medical conditions that could interfere with the study treatment or affect their safety cannot participate.
Patients who are currently participating in another clinical trial cannot join this study.
Patients who have had a recent major surgery or have not fully recovered from a previous surgery cannot participate.
Patients who have a history of severe allergic reactions to any of the study medications cannot participate.
Patients who have an active infection or other serious illness that could affect their ability to participate in the study cannot join.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Jessa Ziekenhuis	Hasselt	Belgium
Cumsbe Lmsd Bhgzma	Lyon	France
Lirwr Uvjbjkzrpnwf Mgvuyps Chyihdi (trhuj	Leiden	The Netherlands
Hjcvvvqa Usezxmsnrkgqfv db Muuktzefv Tcvkdb	Marseille	France
Ubrzqirfsyjpof Czlkxwt Kbxrfpfko	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	10.09.2019
France	Not recruiting	10.09.2019
Germany	Not recruiting	10.09.2019
Poland	Not recruiting	10.09.2019
The Netherlands	Not recruiting	10.09.2019

Trial locations

Investigated drugs:

PDC*lung01 is a therapeutic cancer vaccine being studied for its safety, tolerability, and potential effectiveness in treating non-small-cell lung cancer (NSCLC). This vaccine is designed to help the body’s immune system recognize and fight cancer cells more effectively. It is being tested both on its own and in combination with other treatments to see how well it works in different scenarios.

Pemetrexed is a medication used in the treatment of certain types of lung cancer, specifically adenocarcinomas. In this trial, it is used as a maintenance treatment to help prevent the cancer from growing or spreading after initial therapy. It works by interfering with the cancer cells’ ability to grow and divide.

Anti-PD-1 Therapy refers to a type of treatment that helps the immune system attack cancer cells. PD-1 is a protein on the surface of immune cells that, when activated, can prevent the immune system from attacking cancer cells. Anti-PD-1 therapies block this protein, allowing the immune system to better target and destroy cancer cells. This therapy is being tested in combination with the PDC*lung01 vaccine to evaluate its effectiveness in treating non-small-cell lung cancer.

Investigated diseases:

Non-small cell lung cancer

Non-small-cell lung cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. The progression of non-small-cell lung cancer can vary greatly depending on the subtype and stage at diagnosis.

Trial ID:

2024-517429-24-00

Protocol code:

PDC-LUNG-101

NCT ID:

NCT03970746

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effects of PDC*lung01 Vaccine with Pemetrexed or Pembrolizumab for Patients with Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?