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Study of Drug Combination with Pembrolizumab Guided by Blood Biomarkers for Patients with Metastatic Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at metastatic non-small cell lung cancer, which is an advanced form of lung cancer that has spread to other parts of the body. The study will use several different medications to treat this condition. One treatment option is pembrolizumab, which is a type of immunotherapy that helps the body's immune system fight cancer cells. Other medications that may be used in combination include chemotherapy drugs such as Abraxane (which contains paclitaxel albumin-bound), paclitaxel, cisplatin, carboplatin, and pemetrexed. These chemotherapy drugs work by stopping cancer cells from growing and dividing. The purpose of this study is to find out whether adding chemotherapy to immunotherapy treatment improves how long patients live without their cancer getting worse and their overall survival time, based on a blood test that measures cancer markers called circulating tumor DNA.

Patients entering this study must have already started treatment with pembrolizumab for their advanced lung cancer and received at least one or two cycles of this medication. Before joining the study, patients will have a special blood test that looks for circulating tumor DNA, which are small pieces of cancer genetic material that can be found in the blood. This blood test helps doctors understand how the cancer is responding to treatment. Patients will also have imaging scans such as computed tomography of the chest, abdomen, and pelvis, and possibly brain scans to check all areas where cancer may be present. These tests must show that the cancer is stable or responding to treatment, not rapidly getting worse.

Once enrolled in the study, patients will be randomly assigned to continue receiving pembrolizumab alone or to receive pembrolizumab combined with chemotherapy. The chemotherapy combinations may vary depending on the specific type of lung cancer cells. Treatment will continue for up to twelve months for chemotherapy and up to twenty-four months for pembrolizumab, depending on how well the treatment works and how the patient tolerates it. Throughout the study, doctors will monitor patients closely with regular blood tests and imaging scans to see how well the treatment is working and to check for any side effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
Prior to joining this study, you will have already received at least one but not more than two cycles of pembrolizumab at a dose of either 200 mg or 2 mg per kilogram of body weight, given through an intravenous infusion every 3 weeks. Alternatively, you may have received at least one but not more than one cycle of pembrolizumab at a dose of 400 mg or 4 mg per kilogram of body weight, given through an intravenous infusion every 6 we weeks.
This initial treatment is part of your first-line therapy for advanced lung cancer.
Step 2
Screening and enrollment
A blood sample will be collected to measure the level of ctDNA (circulating tumor DNA, which are small fragments of cancer DNA found in the bloodstream). This test is required to determine if you can proceed in the study.
Imaging scans, including a CT scan (a type of X-ray that creates detailed images of the inside of your body) of your chest, abdomen, and pelvis, will be performed within 14 days before you are assigned to a treatment group. If you have known brain metastases (cancer that has spread to the brain), an MRI or CT scan of the brain will also be done.
These scans are performed to ensure your disease has not progressed to a point that would require a change in your cancer treatment.
You must have detectable ctDNA in your blood sample to be assigned to a treatment group.
Step 3
Assignment to treatment group
Based on your ctDNA level and other factors, you will be assigned to one of two treatment groups. This assignment will determine whether you continue receiving pembrolizumab alone or receive pembrolizumab combined with chemotherapy.
Step 4
Treatment with pembrolizumab alone
If assigned to this group, you will continue receiving pembrolizumab as a solution for infusion (a liquid medication given slowly into a vein over a period of time).
The dose and schedule will follow the same regimen you received before joining the study: either 200 mg or 2 mg per kilogram of body weight every 3 weeks, or 400 mg or 4 mg per kilogram of body weight every 6 weeks.
This treatment will continue for as long as it is effective and you do not experience unacceptable side effects.
Step 5
Treatment with pembrolizumab combined with chemotherapy
If assigned to this group, you will receive pembrolizumab combined with chemotherapy medications.
The chemotherapy medications may include one or more of the following, given as a solution for infusion:
Paclitaxel albumin-bound (Abraxane), which is a chemotherapy drug that helps stop cancer cells from dividing.
Cisplatin, a chemotherapy drug that damages the DNA of cancer cells.
Carboplatin, another chemotherapy drug similar to cisplatin that damages cancer cell DNA.
Paclitaxel, a chemotherapy drug that prevents cancer cells from dividing.
Pemetrexed disodium, a chemotherapy drug that interferes with the growth of cancer cells.
The specific chemotherapy medications, dosages, frequency, and duration of administration will be determined by your medical team based on your individual condition and the study protocol.
This combined treatment will continue for as long as it is effective and you do not experience unacceptable side effects.
Step 6
Ongoing monitoring during treatment
Throughout the study, you will have regular medical examinations and blood tests to monitor your health and the effectiveness of the treatment.
Imaging scans will be performed at scheduled intervals to assess how your cancer is responding to treatment.
Blood samples may be collected periodically to measure ctDNA levels and other biomarkers (substances in your blood that can provide information about your disease).
Any side effects or symptoms you experience will be recorded and managed by your medical team.
Step 7
End of treatment
Treatment will continue until your cancer progresses, you experience unacceptable side effects, or you decide to withdraw from the study.
At the end of treatment, final assessments will be performed to evaluate your overall response to the therapy.
Step 8
Follow-up period
After completing treatment, you will enter a follow-up period during which your health will continue to be monitored.
The study team will track your overall survival and long-term outcomes as part of the research objectives.

Who can join the trial?

17 criteria

You must have metastatic non-small cell lung cancer, which means lung cancer that has spread to other parts of the body, confirmed by tissue examination under a microscope
Patients with stage three disease can join if surgery or combined chemotherapy and radiation treatment is not an option for them
You must have test results showing that your cancer does not have EGFR or ALK mutations, which are specific changes in cancer genes
Your cancer must have a PD-L1 score of 50% or higher, which is a protein marker found on cancer cells measured through laboratory testing
You must have already received at least one but no more than two treatment cycles of pembrolizumab, which is a type of immunotherapy medicine that helps your immune system fight cancer
If you received chemotherapy or immunotherapy before your cancer spread, at least six months must have passed between finishing that treatment and starting pembrolizumab
If you had radiation therapy for pain relief, at least two weeks must have passed since completing it, except for brain radiation which has no waiting period required
If you had major surgery, at least 14 days must have passed before screening and 28 days before joining the study, and your surgical wounds must be healed
You must be suitable to continue receiving pembrolizumab alone or with added chemotherapy
Your condition must be stable without signs that your cancer is getting worse in a way that requires changing your treatment
You must be at least 18 years old
Your general health and ability to care for yourself must be reasonable, rated on a scale where 0 means fully active and 2 means able to care for yourself but unable to work
Your cancer must be visible on scans or through clinical examination
You must have recent scans including CT scans of your chest, abdomen, and pelvis within 14 days before joining to confirm your cancer is not progressing rapidly
If you have cancer that has spread to your brain, you must have a brain scan within this time period
Your scans must show that your disease is either not progressing or is stable enough to continue immunotherapy
You must have detectable ctDNA in your blood, which are small pieces of cancer DNA that can be measured through a blood test

Who cannot join the trial?

2 criteria

The source data does not provide specific exclusion criteria (reasons why patients cannot participate in this study)
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this clinical trial

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Verified
Catania, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

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Investigated drugs

Immuno-chemotherapy is a combination treatment that uses two types of cancer-fighting approaches together. The first part, immunotherapy, works by helping your own immune system recognize and attack cancer cells more effectively. The second part, chemotherapy, uses medications that directly kill cancer cells or stop them from growing and dividing. In this study, the specific combination of these treatments will be chosen based on the results of blood tests that look for circulating tumor DNA (ctDNA), which are tiny pieces of cancer DNA that can be found in your bloodstream.

What is already known about the treatment

Immuno-Chemotherapy – This is a combination treatment approach that merges immunotherapy drugs, which help the immune system fight cancer cells, with traditional chemotherapy medications that directly kill rapidly dividing cancer cells. In this clinical trial, the treatment is being studied specifically for patients with metastatic non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study uses a personalized approach by monitoring ctDNA (circulating tumor DNA) in the blood to adapt the treatment based on how well the cancer is responding, aiming to improve patient survival and reduce disease progression.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lung tissue and accounts for the majority of lung cancer cases. The disease develops when cells in the lungs grow abnormally and uncontrollably, forming tumors that can interfere with normal lung function. As the cancer progresses, it can spread beyond the lungs to other parts of the body through the bloodstream or lymphatic system, which is called metastasis. Metastatic non-small cell lung cancer means the cancer has spread to distant organs or tissues. Common symptoms include persistent cough, chest pain, shortness of breath, and unexplained weight loss. The disease typically progresses more slowly than small cell lung cancer, but its advancement varies depending on individual factors.