This study focuses on treating Small Cell Lung Cancer (SCLC) that has returned after initial treatment with platinum-based chemotherapy. The study compares two treatment approaches: a new medication called tarlatamab versus standard care treatments that include topotecan, dexamethasone, tocilizumab, and siltuximab. The purpose is to determine if tarlatamab helps patients live longer compared to standard treatments.
Tarlatamab is given through an intravenous infusion, which means it is delivered directly into a vein. The standard care medications may be given either as infusions into a vein or as oral capsules, depending on the specific medication. During treatment, doctors will monitor how well the medications work and track any changes in the cancer.
Throughout the study, healthcare providers will assess various aspects of participants’ health, including chest pain, coughing, breathing difficulties, and overall well-being. They will also monitor how the disease responds to treatment and track how long participants survive after starting treatment. The study medication or standard care will be continued as long as it provides benefit to the participant and is well tolerated.
1Initial screening and assignment
Your eligibility for the study will be evaluated based on specific criteria, including confirmation of small cell lung cancer that has returned or progressed after platinum-based treatment.
If eligible, you will be randomly assigned to receive either tarlatamab or standard care treatment.
2Treatment administration
You will receive treatment through intravenous infusion (medication given directly into a vein).
The treatment will be either tarlatamab or one of the standard care medications (topotecan, dexamethasone, tocilizumab, or siltuximab).
The treatment will continue until your disease progresses or other stopping criteria are met.
3Regular assessments
Your health status will be evaluated every 6 weeks for the first 18 weeks.
Assessments will include monitoring of chest pain, cough, chest tightness, and your overall physical function.
Regular scans will be performed to check if your disease has progressed.
4Long-term follow-up
Your health status will continue to be monitored throughout the study period.
The study is expected to continue until March 2028.
Your participation will help evaluate how well tarlatamab works compared to standard treatments in extending survival time.
Who Can Join the Study?
Must be able to provide informed consent to participate in the study
Must be at least 18 years old or meet the legal adult age requirement in your country (whichever is higher)
Must have confirmed small cell lung cancer that has returned or worsened after previous treatment
Must have had disease progression or recurrence after receiving one platinum-based treatment (a specific type of chemotherapy)
Must have measurable disease that can be evaluated through imaging within 21 days before starting the study
Must have good physical functioning ability, scoring either 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work) on the ECOG scale
Must have a life expectancy of at least 12 weeks
Must have adequate organ function (meaning your major organs are working well enough to participate safely)
Who Cannot Join the Study?
Prior treatment with any DLL3-targeted therapy (a specific type of targeted cancer treatment)
Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
History of another cancer within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Tarlatamab is an investigational medication being studied for treating small cell lung cancer in patients whose cancer has returned after initial platinum-based chemotherapy. It is a targeted therapy designed to find and attack cancer cells. The medication is being compared to standard treatments currently used for this type of cancer.
Standard of Care (SOC) refers to the current best available treatments that doctors typically use to treat small cell lung cancer after initial chemotherapy has failed. These may include various approved chemotherapy medications that are already established as treatment options for this condition.
Small Cell Lung Cancer (SCLC) – A fast-growing type of lung cancer that develops in the lungs’ small cells, typically in the bronchi. It is characterized by rapid cell division and early spread throughout the body. The cancer cells are smaller in size than most other types of lung cancer cells, which gives the disease its name. SCLC typically starts in the airways of the lungs and can spread quickly to other parts of the body. The condition often develops in people with a history of smoking.
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