Study on Trastuzumab Deruxtecan for Patients with Advanced Non-Small Cell Lung Cancer with HER2 Mutations

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that cannot be surgically removed and has specific genetic changes called HER2 exon 19 or 20 mutations. The study is investigating the effectiveness and safety of a treatment called trastuzumab deruxtecan, also known by its code name DS-8201a, as the first treatment option for this type of cancer. Trastuzumab deruxtecan is a special type of medication that combines an antibody with a chemotherapy drug, designed to target and kill cancer cells more effectively.

Participants in the study will receive either trastuzumab deruxtecan or a combination of other medications, including pemetrexed, carboplatin, cisplatin, and pembrolizumab. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The purpose of the study is to compare how well trastuzumab deruxtecan works in stopping the cancer from growing or spreading compared to the other treatment options. The study will also look at the overall survival of participants and monitor any side effects they may experience.

The trial will take place over several years, with regular check-ups and assessments to monitor the participants’ health and the progress of their cancer. The study aims to provide valuable information on the best treatment options for patients with this specific type of lung cancer, potentially leading to improved outcomes and quality of life for those affected by the disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, disease stage, and health status.

Participants must have a type of lung cancer with specific genetic mutations and must not have received certain treatments before.

2 randomization

Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being studied.

3 treatment administration

Participants in one group receive trastuzumab deruxtecan (also known as DS-8201a) through an intravenous infusion. The frequency and dosage are determined by the study protocol.

Participants in the other group receive a combination of platinum-based chemotherapy (either carboplatin or cisplatin), pemetrexed, and pembrolizumab, all administered intravenously. The specific dosage and schedule are outlined in the study protocol.

4 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor the effectiveness of the treatment and any side effects. This includes imaging tests to evaluate the cancer’s response to treatment.

Participants’ health is closely monitored through various tests, including blood tests and heart function tests, to ensure safety and adjust treatment as necessary.

5 follow-up

After completing the treatment phase, participants continue to be monitored for a period to assess long-term outcomes and any delayed side effects.

The study aims to measure outcomes such as progression-free survival, overall survival, and quality of life.

Who Can Join the Study?

  • Participants must be male or female and at least 18 years old.
  • The disease must be locally advanced (meaning it has spread but not to distant parts of the body) and cannot be treated with surgery to cure it, or it must be metastatic (meaning it has spread to other parts of the body).
  • The type of lung cancer must be non-squamous Non-Small Cell Lung Cancer (NSCLC) with a specific HER2 mutation in parts of the gene called exons 19 or 20. This must be confirmed by a test on tissue or blood.
  • Participants should not have received any systemic therapy (treatment that affects the whole body) aimed at relieving symptoms for their advanced or metastatic disease.
  • The heart’s ability to pump blood, known as Left Ventricular Ejection Fraction (LVEF), must be 50% or higher.
  • The disease must be measurable, meaning it can be assessed by a doctor using specific criteria called RECIST v1.1.
  • Participants must have adequate organ function, which includes the heart, kidneys, and liver, as defined by the study protocol.
  • The ECOG performance status must be 0 or 1, which means the participant is fully active or has some symptoms but can still carry out light work.
  • There must be tumor tissue available for testing by the study team.

Who Cannot Join the Study?

  • Patients who have a type of lung cancer that is not Non-Small Cell Lung Cancer with specific genetic changes called HER2 exon 19 or 20 mutations cannot participate.
  • Patients whose cancer can be removed by surgery are not eligible.
  • Patients who do not have cancer that has spread to other parts of the body or is not advanced in the local area cannot join the study.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups are excluded.
  • Patients who are not considered part of the vulnerable population selected for the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Universita Cattolica Del Sacro Cuore Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Centrum Pulmonologii I Torakochirurgii W Bystrej Wilkowice Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Centre Hospitalier Le Mans Le Mans France
Ludwig Maximilian University Of Munich Munich Germany
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
CHU Bordeauxt Bordeaux France
Aohuiki Obdjgvdkzme Uokudvtuuxlyy Pscou Parma Italy
Ctxsyt Lacf Boljnt Lyon France
Osgrseelyqqpoe Lwdo Gxti Linz Austria
Uoqgastjgtsd Mzofqeu Comeqxj Gkzvaogzn Groningen The Netherlands
Inlglwnk Cykxkx Dfvgpisfgozzrxjeq L'hospitalet De Llobregat Spain
Uafcetftzx Hmxpdujj Cehthhf Cologne Germany
Awiznmchx Uur Amsterdam The Netherlands
Apkxiqbxfv Ptwgwhrk Hvcqcwcw Dr Mdxjgnuml Marseille France
Svtxxsglu Rzegnns Ubyanayzkn Mwwvond Cmuisl Nijmegen The Netherlands
Nmbxrbnz Ihzbbnyb Odjafntwi Idu Miukn Ssjdbdwioajuupauqckihaplsphv Ibvgczgd Bfvomdms Cracow Poland
Uuzisucmwizdwz Cozaboa Kdpxndbof Gdansk Poland
Wawekjoiav Ssjeomz Ibs Sqtpmpe Pow W Pwczjutgq Przemysl Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.06.2024
Belgium Belgium
Not recruiting
13.06.2024
Denmark Denmark
Not recruiting
13.06.2024
France France
Not recruiting
13.06.2024
Germany Germany
Not recruiting
13.06.2024
Italy Italy
Not recruiting
13.06.2024
Poland Poland
Not recruiting
13.06.2024
Spain Spain
Not recruiting
13.06.2024
The Netherlands The Netherlands
Not recruiting
13.06.2024

Trial locations

Trastuzumab Deruxtecan: This medication is being studied as a first-line treatment for patients with a specific type of lung cancer that cannot be removed by surgery or has spread to other parts of the body. It targets cancer cells with certain mutations in the HER2 gene, which are found in some lung cancers. The goal is to see if this medication can help stop the cancer from growing or spreading.

Platinum: This is a type of chemotherapy drug used to treat various cancers, including lung cancer. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing.

Pemetrexed: This is another chemotherapy drug that is often used in combination with other medications to treat lung cancer. It works by interfering with the cancer cells’ ability to use folate, a vitamin that is necessary for cell growth.

Pembrolizumab: This medication is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is used to treat several types of cancer, including lung cancer, by blocking a protein that prevents the immune system from attacking cancer cells.

Non-Small Cell Lung Cancer with HER2 exon 19 or 20 mutations – This is a type of lung cancer that is characterized by mutations in the HER2 gene, specifically in exon 19 or 20. It is classified as non-small cell, which is the most common type of lung cancer, accounting for about 85% of cases. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, indicating it has spread to other parts of the body. The presence of HER2 mutations can influence the behavior of the cancer, potentially affecting its growth and spread. This form of cancer is considered unresectable, meaning it cannot be removed completely through surgery. The progression of the disease is typically monitored through imaging and clinical assessments to evaluate changes in tumor size and spread.

Trial ID:
2023-503674-20-00
Protocol code:
D967SC00001
NCT ID:
NCT05048797
Trial Phase:
Therapeutic confirmatory (Phase III)

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