Not recruiting

Study of datopotamab deruxtecan combined with immunotherapy and carboplatin in patients with advanced or metastatic non-small cell lung cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on treating patients with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). The main treatment combines several medications including Datopotamab Deruxtecan (also called Dato-DXd) with different types of immunotherapy medicines (Durvalumab, Volrustomig, Rilvegostomig, Sabestomig), with some patients also receiving Carboplatin. The purpose is to evaluate if these drug combinations are safe to use and how well patients can tolerate them.

The study involves two main parts where patients receive different combinations of these medications through intravenous infusions. Some participants will receive Dato-DXd with one type of immunotherapy medicine, while others will receive Dato-DXd with immunotherapy plus carboplatin. The medications work in different ways to fight cancer - Dato-DXd directly targets cancer cells, while immunotherapy helps the body's immune system fight the cancer.

Throughout the study, doctors will monitor how patients respond to the treatment and check for any side effects. They will also look at how the medications work in the body and how effective they are at fighting the cancer. The treatment may continue as long as it is helping the patient and side effects remain manageable.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and qualification
Your eligibility for the study will be confirmed based on specific medical criteria, including confirmation of advanced or metastatic non-small cell lung cancer (NSCLC)
A medical examination will be performed to verify your general health status and ECOG performance status (a measure of your daily living abilities)
Laboratory tests will be conducted to check your bone marrow and organ function
Step 2
Tumor biopsy
A tumor sample will be collected for analysis
If you had a tumor biopsy within the last 3 months, it may be used instead of a new one
For specific study groups (Cohorts 12 and 13), a tumor sample taken within 24 months before screening may be acceptable
Step 3
Treatment administration
You will receive a combination of medications through intravenous infusion
The treatment includes Datopotamab deruxtecan (Dato-DXd) combined with immunotherapy
Some participants may also receive up to 4 cycles of carboplatin
The specific medication combination will depend on your assigned study group
Step 4
Monitoring and assessments
Regular medical examinations will be conducted to monitor your health status
Tests will include blood work, urinalysis, heart monitoring (ECG), and eye examinations
Tumor measurements will be performed to assess treatment response
Blood samples will be collected to measure medication levels in your body
Step 5
Study duration
The study is expected to continue until January 30, 2026
Your participation duration will depend on how your body responds to the treatment
Regular assessments will determine if you should continue with the treatment

Who can join the trial?

9 criteria

Must be 18 years or older when signing the consent form
Must have confirmed advanced or metastatic non-small cell lung cancer (NSCLC) - cancer that has spread beyond the lungs
For specific study groups (Cohorts 1-4): Either no previous treatment or only one prior chemotherapy treatment that stopped working. For other groups (Cohorts 4a, 5-11, 14): No previous treatment for advanced lung cancer
Must be willing to undergo a tumor biopsy (removal of small tissue sample for testing). Recent biopsies within 3 months may be accepted
Must have tumors that can be measured using standard imaging tests within 28 days before starting treatment
Must have good physical functioning ability (ECOG performance status of 0 or 1), meaning able to perform daily activities with minimal assistance
Must have adequate bone marrow and organ function, which will be determined by blood tests
For certain study groups (Cohorts 5-14): Must have confirmed PD-L1 expression (a specific protein marker) in tumor tissue through approved laboratory testing
Both men and women may participate in the study

Who cannot join the trial?

13 criteria

Previous treatment with TROP2-targeting therapy (a specific type of cancer treatment)
Active or untreated brain metastases (cancer that has spread to the brain)
History of interstitial lung disease (a condition affecting lung tissue) or pneumonitis (lung inflammation)
Significant heart conditions including heart failure or uncontrolled high blood pressure
Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
Other active cancers requiring treatment (except for certain skin cancers or in situ cancers)
Major surgery within 4 weeks before starting the study treatment
Pregnant or breastfeeding women
Known allergic reactions to the study medications or their components
Severe kidney or liver problems
Uncontrolled diabetes (high blood sugar levels)
Participation in another clinical trial within 4 weeks before this study
Any medical condition that the study doctor believes would make participation unsafe

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Verified sites

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

Algemeen Ziekenhuis Delta
Verified
Roeselare, Belgium
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

Datopotamab Deruxtecan (Dato-DXd) is an antibody-drug conjugate that targets specific cancer cells in non-small cell lung cancer. It works by delivering anti-cancer medication directly to tumor cells while trying to minimize damage to healthy cells. Carboplatin is a chemotherapy medication commonly used to treat various types of cancer, including lung cancer. It works by interfering with cancer cell DNA, which helps stop cancer cells from growing and dividing. Immunotherapy (specific type not specified in the source data) is a type of treatment that helps your immune system fight cancer. It works by either stimulating your own immune system to work harder or by giving you immune system components to help your body fight cancer cells.

What is already known about the treatment

Datopotamab Deruxtecan (Dato-DXd)
An investigational antibody-drug conjugate administered intravenously that is being studied for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The medication works by delivering a potent chemotherapy agent directly to cancer cells that express a specific protein called TROP2, while limiting damage to healthy cells. This targeted therapy is currently being evaluated in clinical trials in combination with immunotherapy and carboplatin to determine its safety and effectiveness in treating lung cancer patients.
Carboplatin
A platinum-based chemotherapy drug administered through intravenous infusion that is commonly used to treat various types of cancer, including non-small cell lung cancer. It works by binding to DNA in cancer cells, interfering with their ability to divide and multiply, ultimately leading to cell death. The medication belongs to the platinum-containing compounds class and is often used in combination with other cancer treatments to enhance therapeutic effectiveness.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and forms in the tissues of the lung, typically in the cells lining the air passages. It develops when cells in the lungs begin to grow uncontrollably and form tumors. NSCLC can spread (metastasize) from its original location to other parts of the body through blood or lymph system. Advanced NSCLC means the cancer has spread extensively within the lungs or to other parts of the body. This disease progresses gradually and may initially develop without noticeable symptoms.