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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Jessa Ziekenhuis	Hasselt	Belgium
Emjrlnx	Mechelen	Belgium
Ivssqjzy Rjnwaxcqy Pne Lv Sgodui Dpl Tiuwlc Dxkv Ascwfbe Igyf Sbnumy	Meldola	Italy
Nfpurgxp Ijpenpfh Odhwknidl Iox Midro Sfkqzizkyfhtugiwenbdhyaqiaoa Iknefvoq Bagwpmai	Cracow	Poland
Uhhvkmojvklwdu Cbpdmzr Ketibmfoe	Gdansk	Poland
Fkobskrjp Pgjs Ll Ihpisucephzum Btjhyhnbt Dku Hqbpowek Uumumqnicwduk Lq Pnq	Madrid	Spain
Hcniepne Upefanxeupmve Hfohmjhw Taqqm y Pirlwr Irqdbore Cgxzli dhanciszhsfiwbpgn (ysmo	Badalona	Spain
Hvtkqcqv Utdhlmwqffijt db A Cnqqxm	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.05.2024
Italy	Not recruiting	15.05.2024
Poland	Not recruiting	15.05.2024
Spain	Not recruiting	15.05.2024

Trial locations

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.

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 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.

Trial ID:

2023-505992-54-00

Protocol code:

D926FC00001

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?