Study of Datopotamab Deruxtecan for Patients with Advanced or Metastatic Non-small Cell Lung Cancer with Specific Genetic Changes

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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 treatment being tested is a medication called Datopotamab deruxtecan, also known by its code name DS-1062a. This medication is given as a solution through an infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to evaluate how well this treatment works in patients whose cancer has specific genetic changes and has worsened after receiving other treatments, including targeted therapies and chemotherapy that contains platinum.

Participants in the study will receive the treatment and be monitored over time to see how their cancer responds. The study will look at various outcomes, such as how many patients experience a reduction in their cancer size, how long any improvement lasts, and the overall survival of the participants. The study will also assess the safety of the treatment by monitoring any side effects that occur during the trial. The trial is designed to gather information on the effectiveness and safety of Datopotamab deruxtecan in treating this specific type of lung cancer.

This study is open-label, meaning both the researchers and participants know what treatment is being given. It is a single-arm study, which means all participants will receive the same treatment without a comparison group receiving a different treatment or a placebo. The trial aims to provide valuable insights into the potential benefits of Datopotamab deruxtecan for patients with Advanced or Metastatic Non-small Cell Lung Cancer who have specific genetic alterations and have not responded to previous treatments.

1 joining the study

Upon joining the study, the patient will be required to sign and date the informed consent form. This is a necessary step before any study-specific procedures can begin.

2 initial assessments

Before starting the treatment, several assessments will be conducted to ensure eligibility. These include blood tests to check bone marrow, liver, and kidney function, as well as heart function tests like an echocardiogram or MUGA scan.

A tumor biopsy may be required if recent samples are not available. This helps in understanding the current state of the disease.

3 treatment administration

The treatment involves the administration of datopotamab deruxtecan, a solution for infusion. This medication is given through an intravenous route, meaning it is delivered directly into the bloodstream via a vein.

The frequency and dosage of the medication will be determined by the study protocol and the healthcare team overseeing the trial.

4 ongoing monitoring

Throughout the study, regular monitoring will be conducted to assess the response to the treatment. This includes imaging tests to measure tumor size and blood tests to monitor overall health.

The patient’s health status will be evaluated using the Eastern Cooperative Oncology Group performance status, which helps in assessing the impact of the disease and treatment on daily activities.

5 response evaluation

The primary goal is to evaluate the overall response rate, which measures the proportion of patients who experience a significant reduction in tumor size.

Secondary evaluations include the duration of response, disease control rate, and progression-free survival, which provide insights into how long the treatment remains effective.

6 safety assessments

Safety is a critical aspect of the study. Adverse events, which are any unwanted effects of the treatment, will be closely monitored and recorded.

Regular assessments will include vital signs, laboratory tests, and other health evaluations to ensure the patient’s safety throughout the trial.

7 study completion

The study is expected to conclude by February 2026. Upon completion, final assessments will be conducted to evaluate the overall impact of the treatment on the patient’s health and disease progression.

Who Can Join the Study?

Sign and date the informed consent form before starting any study-specific procedures.
Be an adult aged 18 years or older.
Have a confirmed diagnosis of Non-small Cell Lung Cancer (NSCLC) that is at an advanced stage (IIIB, IIIC, or IV).
Have specific genetic changes in the tumor, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
Show evidence of disease progression on imaging tests after the most recent treatment for advanced or metastatic NSCLC.
Have received at least one but no more than two treatments containing cytotoxic agents for metastatic NSCLC.
May have received up to one treatment with a checkpoint inhibitor, which is a type of drug that helps the immune system fight cancer.
Have been treated with one or more targeted therapies approved for the specific genetic changes in the tumor.
Undergo a required tumor biopsy before treatment or provide a recent biopsy sample taken within the last three months.
Provide tumor tissue from the initial diagnosis if available.
Have measurable disease based on imaging tests.
Have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Have adequate bone marrow function, which includes having enough platelets, hemoglobin, and neutrophils (a type of white blood cell).
Have adequate liver function, which involves specific levels of liver enzymes and bilirubin.
Have adequate kidney function, with a creatinine clearance of at least 30 mL/min, which measures how well the kidneys are working.
Have a left ventricular ejection fraction (LVEF) of at least 50%, which is a measure of how well the heart pumps blood.
Have normal blood clotting function.
Have a sufficient period without treatment before starting the study, depending on the type of previous treatment.
Have a life expectancy of at least three months, as judged by the study doctor.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied, which is called Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).
Patients who have not previously received treatment with kinase inhibitors and platinum-containing therapy. These are specific types of cancer treatments.
Patients who have not received at least one line of targeted therapy for their specific genetic changes related to the cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are considered part of a vulnerable population that the study does not include.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Agwachepaq Pmuqaips Hfyqmwav Dy Mhrmzehvz	Marseille	France
Eghznjr Uiodswzgmrum Mnkuqhh Cftxtrn Rtjohqmao (nuuvesp Mbw	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2021
Spain	Not recruiting	01.04.2021
The Netherlands	Not recruiting	01.04.2021

Trial locations

Investigated drugs:

Datopotamab Deruxtecan

DS-1062a is an investigational medication being studied for its potential to treat advanced or metastatic non-small cell lung cancer (NSCLC). This medication is being tested in patients whose cancer has specific genetic changes and who have already received other treatments, including kinase inhibitors and platinum-based chemotherapy. The goal of using DS-1062a in this trial is to see if it can help reduce the size of tumors or slow down their growth in these patients.

Investigated diseases:

Non-small cell lung cancer

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-small cell nature, which means the cancer cells are larger than those found in small cell lung cancer. In its advanced or metastatic stage, 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 invade nearby tissues and organs. Over time, these tumors can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-511449-21-00

Protocol code:

DS1062-A-U202

NCT ID:

NCT04484142

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Datopotamab Deruxtecan for Patients with Advanced or Metastatic Non-small Cell Lung Cancer with Specific Genetic Changes

What is this study about?

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Who Cannot Join the Study?