This clinical trial is focused on studying a type of lung cancer known as Small Cell Lung Cancer (SCLC). The study is evaluating a new treatment called Ifinatamab deruxtecan, also known by its code name DS-7300a. This treatment is a special kind of medicine called an antibody-drug conjugate (ADC), which is designed to target cancer cells more precisely. The trial will compare the effectiveness of Ifinatamab deruxtecan with standard chemotherapy treatments, such as Topotecan, in patients whose cancer has returned after initial treatment.
The purpose of the study is to see how well Ifinatamab deruxtecan works compared to chemotherapy in treating SCLC. Participants in the study will receive either Ifinatamab deruxtecan or a treatment chosen by their doctor, which may include Topotecan or other chemotherapy options. The study will monitor how the cancer responds to the treatment and how long patients live after starting the treatment. This will help researchers understand if the new treatment is more effective than the current options.
Participants will receive their assigned treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for a period of time, during which patients will have regular check-ups to monitor their health and the progress of their cancer. The trial aims to provide valuable information that could lead to better treatment options for people with relapsed SCLC in the future.
1joining the study
Sign and date the informed consent form. This is necessary before any study-specific procedures can begin.
Ensure eligibility by meeting criteria such as being an adult, having documented small cell lung cancer (SCLC), and having received prior therapy with a platinum-based treatment.
2randomization
Participants are randomly assigned to receive either the study drug ifinatamab deruxtecan or a treatment chosen by the physician.
3treatment administration
Receive ifinatamab deruxtecan as an intravenous infusion. The frequency and dosage will be determined by the study protocol.
Alternatively, if assigned to the physician’s choice group, receive topotecan as an intravenous infusion, following the physician’s prescribed schedule.
4monitoring and assessments
Undergo regular assessments to monitor the response to treatment. This includes measuring tumor size and checking for any side effects.
Assessments will be conducted by both the study team and an independent review to ensure accuracy.
5follow-up
Continue to be monitored for overall survival and any long-term effects of the treatment.
The study aims to compare the effectiveness of ifinatamab deruxtecan with standard chemotherapy in terms of response rate and survival.
Who Can Join the Study?
Sign and date the informed consent form before starting any study-specific procedures.
Be an adult, which means being at least 18 years old or the minimum legal adult age, whichever is higher, at the time of signing the informed consent form.
Have a confirmed diagnosis of Small Cell Lung Cancer (SCLC) through specific medical tests.
Provide a sample of the tumor that is of good quality and enough quantity for the study.
Have received only one previous treatment with a type of medication called platinum-based therapy for SCLC, with at least two cycles of treatment and a break from chemotherapy of at least 30 days.
Have at least one tumor that can be measured according to specific guidelines called RECIST v1.1, as determined by the study doctor.
Have proof of the disease getting worse on or after the most recent treatment.
Have an ECOG Performance Status of 0 or 1, which is a scale used to assess how well a person can perform daily activities.
Can have brain metastases (cancer spread to the brain) if they are untreated and not causing symptoms, or if they have been treated and are no longer causing symptoms, and do not need treatment with steroids or anticonvulsants, as long as they have recovered from any immediate side effects of radiation therapy.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Small Cell Lung Cancer (SCLC) cannot participate. SCLC is a specific type of lung cancer.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the gender requirements of the study cannot participate. The study includes both male and female participants.
Ifinatamab Deruxtecan (I-DXd) is a medication being studied for its effectiveness in treating small cell lung cancer (SCLC). It is a type of drug known as an antibody-drug conjugate, which means it combines an antibody with a chemotherapy drug. The antibody part helps the medication find and attach to cancer cells, while the chemotherapy part works to kill the cancer cells. This study aims to see how well I-DXd works compared to other chemotherapy treatments chosen by doctors for patients whose cancer has returned after previous treatments.
Small Cell Lung Cancer (SCLC) – This is a fast-growing type of lung cancer that primarily affects smokers. It is characterized by small cells that multiply quickly and form large tumors. SCLC often starts in the bronchi, which are the main airways of the lungs, and can spread rapidly to other parts of the body, including the lymph nodes, liver, bones, and brain. The disease is typically divided into two stages: limited stage, where cancer is confined to one lung and nearby lymph nodes, and extensive stage, where it has spread more widely. Symptoms may include coughing, chest pain, shortness of breath, and weight loss. Due to its aggressive nature, SCLC is often diagnosed at an advanced stage.
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