A study comparing the effectiveness and safety of datopotamab deruxtecan and docetaxel in adults with advanced or metastatic non-squamous non-small cell lung cancer

3 1 1 1

What is this study about?

This study is being conducted to compare the effectiveness and safety of datopotamab deruxtecan against docetaxel in patients with a specific type of Non-Small Cell Lung Cancer. The cancer being studied is non-squamous non-small cell lung cancer, which is a type of lung cancer that does not grow in the flat, scale-like cells found on the surface of the lungs. The study focuses on patients whose cancer is TROP2-positive, meaning the cancer cells have a specific protein called TROP2 on their surface, and who do not have actionable genomic alterations, which are specific genetic changes in the cancer cells that can be targeted by other existing drugs.

The cancer being investigated is also classified as advanced or metastatic, meaning it has grown beyond the original part of the lung or has spread to other parts of the body. Participants in this trial will receive their treatment through intravenous use, which involves delivering the medication directly into a vein using a liquid solution for infusion. The study will monitor how long the cancer remains stable without growing and the overall length of time patients live during the trial.

Who Can Join the Study?

  • You must have a confirmed diagnosis of non-squamous non-small cell lung cancer, which is a specific type of lung cancer that does not involve certain cell shapes, in stage IIIB, IIIC, or IV.
  • Your cancer must be advanced or metastatic, meaning it has spread to other parts of the body.
  • You must test negative for specific genetic changes in your cancer cells, such as EGFR, ALK, ROS1, NTRK, BRAF, RET, MET exon 14 skipping, KRAS G12C, or HER2. These are called actionable genomic alterations, which are specific genetic mutations that can usually be treated with other targeted medicines.
  • Your cancer must test positive for a protein called TROP2 using a specific testing method called NMR (nuclear magnetic resonance) on a specialized device.
  • Your cancer must have shown signs of progression, which means the disease has grown or spread, while you were receiving your most recent treatment or after you finished it.
  • You must have previously received platinum-based chemotherapy (a type of strong medicine used to kill cancer cells) either alone or combined with anti-PD-1/anti-PD-L1 monoclonal antibodies (a type of immunotherapy that helps the immune system fight cancer).
  • You must be able to provide a tumor sample that has been preserved using a method called FFPE (formalin-fixed paraffin-embedded) so that doctors can test for the TROP2 protein.
  • You must have at least one tumor lesion (an area of abnormal tissue) that has not been treated with radiation and is large enough to be clearly measured using a CT scan or MRI.
  • Your ECOG performance status must be 0 or 1, which means you are able to carry out most daily activities and are generally well.
  • Your bone marrow (the part of your body that makes blood cells) and your organ function (how well your organs like the liver or kidneys work) must be healthy and meet specific requirements.

Who Cannot Join the Study?

  • People with squamous cell carcinoma, mixed non-small cell lung cancer, or small cell lung cancer, which are different types of lung cancer cell shapes.
  • People who have severe pulmonary function compromise, meaning their lungs do not work well enough to breathe normally.
  • People whose lung cancer can be treated with definitive local therapy, which refers to treatments like surgery or radiation that target only one specific area.
  • People who have had another primary malignancy, which is a different type of cancer, unless it was fully treated and has been gone for at least 3 years.
  • People with spinal cord compression, where a tumor presses on the spine, or brain metastases, which are cancer cells that have spread to the brain, unless these conditions are stable and not causing symptoms.
  • People who require corticosteroids (steroid medicines to reduce swelling) or anticonvulsants (medicines to prevent seizures) for the conditions mentioned above.
  • People with clinically significant corneal disease, which means there is a serious problem with the clear front part of the eye.
  • People with an active or uncontrolled hepatitis B or C virus infection, which are viruses that cause inflammation of the liver.
  • People with an HIV infection that is not well controlled.
  • People with an uncontrolled infection that requires medicine given through a vein, such as antibiotics, antivirals, or antifungals.
  • People with a history of non-infectious ILD or pneumonitis, which are conditions involving inflammation or scarring of the lung tissue that is not caused by an infection.
  • People who currently have or are suspected of having ILD or pneumonitis that cannot be ruled out by medical imaging.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Haemato-Onkologie Hamburg – Prof. Laack und Partner Hamburg Germany
Koranyi National Institute For Pulmonology Budapest Hungary
Medical University Of Graz Graz Austria
Oncopole Claudius Regaud Toulouse France
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
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
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany
HELIOS Klinikum Krefeld GmbH Krefeld Germany
Asklepios Klinik Gauting GmbH Gauting Germany
Hospital Universitario 12 De Octubre Madrid Spain
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Muehlenkreiskliniken AöR Minden Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Vitaz Sint-Niklaas Belgium
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hopital De Libramont Libramont-Chevigny Belgium
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
MVZ-Onkologie Velbert GbR Velbert Germany
Onkologie Rheinsieg Praxisnetzwerk Troisdorf Germany
University Of Debrecen Debrecen Hungary
Matrai Gyogyintezet Gyongyos Hungary
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Semmelweis University Budapest Hungary
Hopital Ambroise Pare Boulogne-Billancourt France
Kliniken der Stadt Koeln gGmbH Cologne Germany
Kepler Universitaetsklinikum GmbH Linz Austria
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
CHU Helora La Louviere Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Cvohco Ltgb Bxhvav Lyon France
Uutivkjvlqibflahmpudt Ebtcg Apq Essen Germany
Ihdvcgfn Cbjpfc Dtcuewjybzqejcxpf L'hospitalet De Llobregat Spain
Bmrfnfctzof Veqxmsxuy Onxxphdggtpv Kecskemet Hungary
Ahikapfaxy Psaxfazw Hqlwugme Dd Mridxtxqk Marseille France
Gxpuijefaksyblyih Vtnbesidj Pvqn Ayqjim Ephdfjss Ojuvlj Kykxup Gyor Hungary
Nczbtmjf Iprgmhxg Oofxwbfks Idh Mloom Swioluqqpyltlxzmicpfenbcowxe Ipscooad Bbamojxd Cracow Poland
Hygqnpxx Vykt dqcyznhq Barcelona Spain
Hrvxjizd Ufslqesbjzarx dq A Chkdax A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
31.10.2025
Belgium Belgium
Not yet recruiting
31.10.2025
France France
Recruiting
31.10.2025
Germany Germany
Recruiting
31.10.2025
Hungary Hungary
Recruiting
31.10.2025
Italy Italy
Not yet recruiting
31.10.2025
Poland Poland
Recruiting
31.10.2025
Spain Spain
Not yet recruiting
31.10.2025

Trial locations

Datopotamab deruxtecan is a targeted therapy given through a vein that works by delivering medicine directly to certain proteins found on the surface of cancer cells to help fight the disease.

Docetaxel is a type of chemotherapy drug given through a vein that works by stopping cancer cells from dividing and growing.

Investigated diseases:

Non-squamous non-small cell lung cancer – This is a type of lung cancer that does not originate from squamous cells, which are flat cells found in the lining of the airways. Instead, it develops from other types of cells within the lungs. The disease can start in one area and may eventually spread to other parts of the body. As it progresses, the cancer cells multiply and can interfere with normal lung function. It is characterized by the absence of specific genetic changes that are typically targeted by certain therapies.

Trial ID:
2024-520101-39-00
Protocol code:
D763QC00001
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of MK-1084 plus durvalumab versus placebo plus durvalumab in patients with locally advanced KRAS G12C‑mutant non‑small cell lung cancer after chemoradiotherapy

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy The Netherlands Poland +1
  • Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

    Recruiting

    2 1 1 1
    Investigated diseases:
    France Germany Spain