Evaluating shorter duration of pembrolizumab and pemetrexed treatment in patients with metastatic non-small cell lung cancer who have not progressed after 6 months

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What is this study about?

This study focuses on patients with metastatic non-small cell lung cancer (NSCLC) who have been receiving initial treatment with medications that help the immune system fight cancer. The study uses two medications: pembrolizumab (KEYTRUDA), which works with the immune system to fight cancer cells, and pemetrexed (ALIMTA), a chemotherapy drug. Both medications are given through an intravenous infusion, which means they are delivered directly into a vein.

The purpose of this research is to determine if patients can benefit from a shorter duration of standard treatment while maintaining its effectiveness. The study involves patients who have been receiving treatment for about 6 months and whose cancer has not gotten worse during this time. These patients will continue receiving their current treatment for up to 18 months while being monitored for any changes in their condition.

During the study, doctors will regularly check how the cancer responds to treatment through various medical examinations. The medications will be given at specific doses – pembrolizumab at up to 200 mg per dose and pemetrexed at 500 mg per square meter of body surface area. The treatment will continue for up to 18 months, during which time patients will be monitored for any changes in their health and how well the treatment is working.

1 Initial qualification

Your eligibility for the trial will be confirmed if you have advanced, metastatic non-small cell lung cancer (stage IV)

You must have received first-line treatment with immunotherapy or combined chemotherapy and immunotherapy for 6 months (plus/minus 2 weeks)

Medical imaging must confirm that your disease is either stable or responding to current treatment

The imaging results must be no older than 3 weeks at the time of entering the study

2 Treatment administration

You will receive two medications through intravenous infusion:

KEYTRUDA (pembrolizumab) 25 mg/mL as a solution for infusion

ALIMTA (pemetrexed) 500 mg as a solution for infusion

3 Regular monitoring

Your health status will be evaluated every 3 months

At each visit, you will complete quality of life questionnaires

Medical imaging will be performed to assess your response to treatment

Any side effects will be recorded and classified according to standard criteria

4 Study duration

Your participation in the study will continue for up to 18 months after entering the trial

During this time, you will be monitored for how your disease responds to treatment

The overall study is planned to run from August 2025 to August 2031

Who Can Join the Study?

  • Must be an adult (18 years or older)
  • Must have advanced non-small cell lung cancer that has spread to other parts of the body (stage IV)
  • Must have been receiving first-line immunotherapy (treatment that helps your immune system fight cancer) or combination of chemotherapy and immunotherapy for about 6 months (plus or minus 2 weeks)
  • Must have a stable condition or showing improvement based on recent imaging tests (performed within the last 3 weeks)
  • Must be in relatively good physical condition, able to carry out daily activities (ECOG performance status between 0-2, which means being able to care for yourself and being up and about more than half of your waking hours)
  • Must be physically able and willing to continue current cancer treatment as determined by your doctor
  • Must sign an informed consent form indicating you understand and agree to participate in the trial
  • Both men and women may participate

Who Cannot Join the Study?

  • Age under 18 years old
  • Active autoimmune disease requiring systemic treatment
  • History of organ transplantation
  • Disease progression during the first 6 months of immunotherapy (treatment that helps your immune system fight cancer)
  • Presence of untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with experimental cancer therapies within 4 weeks before starting this study
  • Significant heart conditions or recent heart attack (within last 6 months)
  • Active or untreated infections, including tuberculosis (TB)
  • Known allergic reactions to study medications
  • Pregnant or breastfeeding women
  • Unable to provide informed consent
  • Participation in another clinical trial within the past 30 days
  • Active second cancer (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Het Van Weel-Bethesda Ziekenhuis Dirksland The Netherlands
Gelre Hospitals Zutphen The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Lsunu Uyzuuuddkdbz Motmfpl Cbkicbi (iyrxd Leiden 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 yet recruiting
01.08.2025

Trial locations

Investigated drugs:

Chemotherapy is a type of cancer treatment that uses powerful drugs to kill cancer cells or stop them from growing and dividing. In this trial, it is used as part of the standard treatment for non-small cell lung cancer.

Immunotherapy is a treatment that helps the body’s immune system fight cancer. It works by boosting or changing how the immune system works so it can better find and destroy cancer cells. In this trial, it is combined with chemotherapy as part of the standard care for metastatic non-small cell lung cancer.

Note: The specific chemotherapy and immunotherapy medications are not explicitly mentioned in the source data, but these are the main treatment types being studied in this de-escalation trial.

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 and form masses called tumors. NSCLC accounts for most lung cancer cases and typically grows and spreads more slowly than small cell lung cancer. When the cancer spreads beyond its original location to other parts of the body, it is called metastatic NSCLC. The disease can affect various parts of the lungs and may gradually impact breathing and other bodily functions.

Trial ID:
2025-520792-67-00
Protocol code:
DIDaC/ NVALT35
Trial Phase:
Therapeutic confirmatory (Phase III)

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