Study of reduced pembrolizumab dosing compared to standard dose in patients with advanced non-small cell lung cancer

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What is this study about?

This study focuses on patients with Non-small cell lung cancer (NSCLC) in advanced stages. The research examines the effectiveness of different dosing approaches of pembrolizumab, a medication used in cancer treatment that works by helping the immune system fight cancer cells. The study aims to determine if using a reduced dose of pembrolizumab can be as effective as the standard dose in treating advanced lung cancer.

The treatment involves giving pembrolizumab through intravenous infusion, which means the medication is delivered directly into a vein. The medication will be administered over a period of up to 24 months. During the study, some patients will receive the standard dose of pembrolizumab (up to 400 mg), while others will receive a reduced dose of the same medication.

The study will monitor how patients respond to different doses of pembrolizumab by tracking their overall health and survival over time. Throughout the treatment period, participants will need to attend regular medical visits for check-ups and monitoring. The medication being studied, pembrolizumab (also known as Keytruda), is already approved for treating certain types of cancer.

1 Initial treatment phase

You will receive pembrolizumab (KEYTRUDA) through an intravenous infusion (delivered directly into your vein)

The treatment is administered as a solution with a concentration of 25 mg/mL

The treatment is intended for advanced non-small cell lung cancer (NSCLC)

2 Treatment duration

Your participation in the study will continue until December 31, 2027

The primary goal is to evaluate your overall survival rate after one year of treatment

During the treatment period, you will need to attend scheduled medical visits and undergo laboratory testing

3 Contraception requirements

If you are a woman who can become pregnant, you must use effective contraception during treatment and for 5 months after the last dose

If you are a male participant with female partners who can become pregnant, you must use effective contraception during treatment and for 7 months after the last dose

Male participants should not donate sperm during the treatment period and for 7 months after the last dose

4 Ongoing requirements

Regular attendance at scheduled medical visits is required

Compliance with all laboratory testing as scheduled by your healthcare team

You must not be breastfeeding during the study period

Who Can Join the Study?

Must be at least 18 years old
Must have confirmed advanced or recurrent non-small cell lung cancer (NSCLC) that can be treated with pembrolizumab (a type of immunotherapy medication)
Must have known PD-L1 status (a protein marker that helps determine if immunotherapy might work) from tissue or cell samples
Must be willing and able to attend all scheduled visits, follow treatment plans, and complete required laboratory tests
Must sign an informed consent form before any study procedures begin
Women must not be breastfeeding
Women who can become pregnant must agree to use effective contraception during treatment and for 5 months after the last dose of pembrolizumab
Men who are sexually active with women who can become pregnant must:
- Use effective contraception during treatment and for 7 months after the last dose
- Agree not to donate sperm during this period

Who Cannot Join the Study?

Active or untreated brain metastases (cancer that has spread to the brain)
History of autoimmune diseases (conditions where the immune system attacks healthy cells)
Current use of systemic corticosteroids (medications that reduce inflammation) or other immunosuppressive medications
Active hepatitis B or C infection
Known history of HIV infection
Active tuberculosis infection
Previous treatment with any immunotherapy (treatments that help your immune system fight cancer)
Other active malignancy (cancer) requiring treatment
Severe heart conditions including uncontrolled high blood pressure
Pregnant or breastfeeding women
Known allergy or sensitivity to study medications
Participation in another clinical trial within the past 30 days
Any condition that would interfere with the safety of the patient or the quality of the study data
Unable to give informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Ziekenhuis Gelderse Vallei Stichting	Ede	The Netherlands
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Groene Hart Ziekenhuis	Gouda	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Amphia Hospital	Breda	The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg	Venlo	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Diakonessenhuis Stichting	Utrecht	The Netherlands
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Elkerliek Ziekenhuis	Helmond	The Netherlands
ZorgSaam Ziekenhuis	Terneuzen	The Netherlands
Ikazia Ziekenhuis	Rotterdam	The Netherlands
Clinical Trial Center Maastricht B.V.	Maastricht	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Deventer Ziekenhuis	Deventer	The Netherlands
Zaans Medisch Centrum Stichting	Zaandam	The Netherlands
Bravis Ziekenhuis	Roosendaal	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands
Rdhhctcpw Znhfupowhf Sjivhgajs	Arnhem	The Netherlands
Udkjjcmdcamw Mkdkwjx Ckijzbp Gsanjjjkl	Groningen	The Netherlands
Sjeknwsln Mmrqtir Zntomzipoh	Groningen	The Netherlands
Bfxhpku Zckqbmiqkk	Gorinchem	The Netherlands
Svhxcxpsbmzlghnn Khiobyoe Bcmtaos	Winterswijk	The Netherlands
Eweimjs Usvajokeqitw Mtacsls Covocai Rnpoiybhv (xkojcnt Mmi	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	18.11.2020

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab is a type of immunotherapy medication that helps the body’s immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, pembrolizumab allows the immune system to better recognize and destroy cancer cells. This medication is commonly used to treat non-small cell lung cancer (NSCLC) and is typically given through an intravenous (IV) infusion.

Investigated diseases:

Non-small cell lung cancer

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and can spread to other parts of the body. It develops when healthy cells in the lung tissue begin to grow uncontrollably, forming masses called tumors. NSCLC accounts for most lung cancer cases and typically grows and spreads more slowly than small cell lung cancer. Advanced NSCLC refers to cancer that has spread beyond its original location to other parts of the body. The disease can affect breathing, cause chest pain, and lead to persistent coughing.

Trial ID:

2024-516195-15-00

Protocol code:

108439

NCT ID:

NCT04909684

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of reduced pembrolizumab dosing compared to standard dose in patients with advanced non-small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?