Study of Datopotamab Deruxtecan and Pembrolizumab for Patients with Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). The study is investigating the effectiveness of a new treatment combination involving two medications: Datopotamab deruxtecan (also known by its code name DS-1062a) and Pembrolizumab (commonly known as Keytruda). These medications are given as a solution through a vein, a method known as intravenous infusion. The trial aims to compare the effects of using both medications together versus using Pembrolizumab alone.

The purpose of the study is to see if the combination of Datopotamab deruxtecan and Pembrolizumab can help patients live longer without their cancer getting worse, compared to those who receive only Pembrolizumab. Participants in the study will be randomly assigned to receive either the combination treatment or Pembrolizumab alone. The study will monitor the participants over a period of time to assess the progression of the disease and overall survival.

Throughout the study, participants will have regular visits to receive their treatment and undergo various tests to monitor their health and the status of their cancer. The study will continue for up to 24 months, and participants will be closely observed to ensure their safety and to gather information on how well the treatments are working. This trial is an important step in exploring new treatment options for people with advanced stages of non-small cell lung cancer.

1 initial treatment phase

Upon joining the study, the patient will begin the initial treatment phase. This involves receiving medications through an intravenous (IV) infusion.

The medications administered are datopotamab deruxtecan and pembrolizumab. Both are given as a solution for infusion.

The frequency and dosage of these medications will be determined by the study protocol and the patient’s specific condition.

2 treatment monitoring

Throughout the treatment period, the patient’s health and response to the medication will be closely monitored.

Regular visits will be scheduled to assess the patient’s condition, including laboratory tests and imaging studies to evaluate the progression of the disease.

The patient’s overall health, including heart function and any side effects, will be evaluated to ensure safety and effectiveness of the treatment.

3 progression-free survival assessment

The primary goal of the study is to measure progression-free survival (PFS), which is the time from the start of treatment until the disease progresses or the patient passes away from any cause.

This assessment will be conducted by an independent review to ensure unbiased results.

4 overall survival assessment

Another key objective is to evaluate overall survival (OS), which is the duration from the start of treatment until death from any cause.

This measure helps determine the long-term effectiveness of the treatment.

5 end of treatment

The treatment phase will continue until the study’s end date or until the patient experiences significant disease progression or adverse effects that necessitate discontinuation.

The estimated end date for the trial is April 30, 2028.

Who Can Join the Study?

  • Sign and date the necessary consent forms before starting any study-specific procedures.
  • Have a life expectancy of at least 3 months.
  • Have adequate bone marrow function as defined in the study protocol.
  • If female and able to have children, must not be pregnant or breastfeeding, and must agree to use effective birth control or avoid heterosexual intercourse during the study and for a specified time after the last dose of study drugs.
  • If male, must be surgically sterile or use a condom along with partner’s use of effective birth control if the partner can have children, or avoid heterosexual intercourse during the study and for a specified time after the last dose of study drugs.
  • Male participants must not freeze or donate sperm during the study and for a specified time after the last dose of study drugs. Consider preserving sperm before joining the study.
  • Female participants must not donate or retrieve eggs during the study and for a specified time after the last dose of study drugs. Consider preserving eggs before joining the study.
  • Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and comply with other study procedures and restrictions.
  • Be an adult, at least 18 years old or the legal adult age in your area, at the time of giving consent.
  • Have a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that meets certain criteria, including being at an advanced stage and not suitable for surgery or certain other treatments.
  • Have negative test results for specific genetic changes in the cancer, such as EGFR, ALK, and ROS1, or be willing to undergo testing for these changes.
  • Provide a tumor tissue sample for testing specific proteins and other markers, unless prohibited by law.
  • Have a tumor with high expression of a protein called PD-L1, as determined by a specific test.
  • Have an adequate period without treatment before starting the study drugs.
  • Have measurable disease based on imaging tests.
  • Have a left ventricular ejection fraction (LVEF) of at least 50%, which is a measure of heart function, determined by specific heart tests.
  • Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, which indicates the level of daily functioning.

Who Cannot Join the Study?

  • Patients with other types of cancer besides Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) cannot participate. This type of cancer affects the lungs and has spread to other parts of the body.
  • Patients who have had previous treatments that might interfere with the study results are not eligible.
  • Patients with serious health conditions that could make it unsafe for them to participate in the study are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits cannot take part.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have allergies to the study medications or similar drugs are excluded.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with a history of certain heart conditions or diseases that affect the immune system are excluded.
  • Patients who have had a recent major surgery or injury that could affect the study are not eligible.
  • Patients with active infections that require treatment are excluded.

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
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Hopital Tenon Paris France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Onco Clinic Consult S.A. Craiova Romania
Sigmedical Services S.R.L. Suceava Romania
Farkasgyepui Tudogyogyintezet Farkasgyepu Hungary
University General Hospital Of Ioannina Ioannina Greece
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Universitario Virgen De Valme Sevilla Spain
Oncomed S.R.L. Timisoara Romania
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
St. Luke’s Hospital S.A. Thessaloniki Greece
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Az Maria Middelares Gent Gent Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Grand Hopital De Charleroi Charleroi Belgium
Krankenhaus Nord Klinik Floridsdorf Vienna Austria
Vitaz Sint-Niklaas Belgium
Institut Sainte Catherine Avignon France
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Bioclinic S.A. Thessaloniki Greece
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Nantes Nantes France
L’Hopital Prive Du Confluent Nantes France
Hospital CUF Porto S.A. Porto Portugal
Metropolitan Hospital Athens Greece
Genesis Mikti Idiotiki Kliniki Gynaikas A.E. Maieutiki Gynaikologiki Cheirourgiki Thessaloniki Greece
Arkahwfjs Ubo Amsterdam The Netherlands
Ajgbbcjski Pmgurelk Hphuzbjt Dz Mdmfsydqd Marseille France
Ksfckdrc dds Uzbjorzwtjqt Mhswxdag Aiv Munich Germany
Ccmikx Lshd Bojnvb Lyon France
Idfrah Iyhsfpea Fslbekdlwqxlk Ouwwpepsjlu Rome Italy
Lqeri Uolifxaaushq Mszzlnc Cznawxd (fcfsy Leiden The Netherlands
Rzxrnxwlg Zlnkkntbuo Slfhdyxkn Arnhem The Netherlands
Shmfeicd Pvagjbjdp Skn z ovai Gdynia Poland
Ljgse Ggprcdd Htoddyey Ob Atydlu Athens Greece
Bppdttlflsm Vpzlxqznv Ozfpdlhpgpbv Kecskemet Hungary
Mr Plnizbs Jexxzv Mgmelvsxii Kepvjbgug Snzbuiemanrupcewfg Srsyxr Jzbqh Lublin Poland
Mmka Cdoqlal Mhzqrwwo Spjswtfv Szczecin Poland
Oqddrouddvehlpggsjlpqakjtg Aalst Belgium
Axpwngs Upw Tvotnqx nazh ochym Leghorn Italy
Hnkxzlou Vfch dbsraefg Barcelona Spain
Itdaghdk Pevnjrwggcahxaa Cqyuny Cxxwqe Marseille France

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
18.07.2022
Belgium Belgium
Not recruiting
18.07.2022
France France
Not recruiting
18.07.2022
Germany Germany
Not recruiting
18.07.2022
Greece Greece
Not recruiting
18.07.2022
Hungary Hungary
Not recruiting
18.07.2022
Italy Italy
Not recruiting
18.07.2022
Poland Poland
Not recruiting
18.07.2022
Portugal Portugal
Not recruiting
18.07.2022
Romania Romania
Not recruiting
18.07.2022
Spain Spain
Not recruiting
18.07.2022
The Netherlands The Netherlands
Not recruiting
18.07.2022

Trial locations

Dato-DXd is an investigational medication being studied for its potential to treat advanced or metastatic non-small cell lung cancer. It is being tested in combination with another medication to see if it can help slow down the progression of the disease or improve survival rates in patients.

Pembrolizumab is a medication used to treat certain types of cancer by helping the immune system recognize and attack cancer cells. In this trial, it is being used alone and in combination with Dato-DXd to determine if the combination provides better outcomes for patients with non-small cell lung cancer.

Investigated diseases:

Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its non-squamous histology. It is termed “advanced” or “metastatic” when the cancer has spread beyond the lungs to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with lung function and spread to other organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to further complications affecting overall health and quality of life.

Trial ID:
2023-507933-12-00
Protocol code:
DS1062-A-U304
NCT ID:
NCT05215340
Trial Phase:
Therapeutic confirmatory (Phase III)

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