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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
Frisius Heerenveen The Netherlands
Stichting OLVG Amsterdam The Netherlands

Other Sites

Site Name City Country Status
Amphia Hospital Breda The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Efaxrnm Urzmflwifwxy Mmwsdpa Cwhvtyj Rutdejkuc (tpghfmt Mkq Rotterdam The Netherlands
Sgxvlbiwn Rqhqojx Unkisuvkgc Muxafpj Cgdrmu Nijmegen The Netherlands
Uscpnvavnppe Mvcqhrk Ctqtzmj Gpeejicty Groningen The Netherlands
Mgzomjw Stclkspe Tniceb Enschede The Netherlands
Zkyrcqkgjm Guhsoqwl Vclykb Snyuehvzp Ede The Netherlands
Scieeuijumofmtrm Kbbcantu Bdfgzur Winterswijk The Netherlands
Mnfdmjhc Zoplvrzoxp Snkjcafht Rotterdam The Netherlands
Cjsvqmnhq Zbculecogy Sczjeuiah Eindhoven The Netherlands
Mxzlkug Mrmozrm Cuwezk Amersfoort The Netherlands
Dzokrute Zekzxcynof Deventer The Netherlands
Zcvbb Msikoci Cwjyzwo Siannkwfe Zaandam The Netherlands
Bmoqhc Zumtdwmmtg Roosendaal The Netherlands
Gtuss Hjikuttyk Zutphen The Netherlands
Nlrmfcant Zoqtznxfpxizymg Sscbhafoe Alkmaar The Netherlands
Rgnneieli Zgoyckfzlc Sdsfephia Arnhem The Netherlands
Gyvmtb Hrlz Zsplhkouxo Gouda The Netherlands
Smyoumapj Mbikpbh Zqysxtoteo Groningen The Netherlands
Cjvqgyjz Tgsrh Cckvat Magzchkdet Bazk Maastricht The Netherlands
Smsxukfzk Vfqdrsa Msucjzo Cvoimcr vxfk Nopywaxqeivgs Venlo The Netherlands
Dnfeietkeuaecga Sunvtlxtc Utrecht The Netherlands
Mfbtxu Mibmcob Chqcnxs Veldhoven The Netherlands
Zdlacziwufoitgu Tifocr Ssqqvtelc Almelo The Netherlands
Ewjawrcgn Zcjroiyekk Helmond The Netherlands
Igixkn Zbchfwaboz Rotterdam The Netherlands
Bvzudoq Zxzmootcox Gorinchem The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
18.11.2020

Trial locations

Investigated Drugs:

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 (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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