Recruiting

Study of Tarlatamab maintenance treatment after chemotherapy and radiation therapy in patients with limited stage small cell lung cancer who cannot receive both treatments together

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Small Cell Lung Cancer (SCLC) who have completed chemotherapy and radiation therapy but were unable to receive both treatments simultaneously. The study evaluates a medication called Tarlatamab (also known as AMG 757), which is given as a solution through intravenous administration.

The purpose of this research is to determine if using Tarlatamab as a maintenance treatment after completing standard chemotherapy and radiation therapy can help prevent cancer from progressing. The study compares two groups of patients - one group receives Tarlatamab while the other continues with standard care after their initial treatment.

During the study, participants receive Tarlatamab through an intravenous infusion at specified intervals. The maximum daily dose is 10 milligrams, and the treatment may continue for up to 24 months. The medication is a biological product, meaning it is derived from living organisms rather than chemical synthesis. Patients will be monitored regularly to assess how well the treatment works and to check for any side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your medical condition must be confirmed as small cell lung cancer (SCLC) through tissue examination
Your doctor will check if you meet all health requirements, including adequate organ function and blood test results
Your heart function will be evaluated through an echocardiogram test
Your oxygen levels must be above 90% when breathing room air
Step 2
Previous treatment completion
You must have completed either chemotherapy alone or chemotherapy followed by radiation therapy
Any side effects from previous treatments must be resolved to mild level or less
Your cancer must not show signs of progression after these treatments
Step 3
Treatment assignment
You will be randomly assigned to one of two groups:
Group 1: Receiving Tarlatamab as maintenance treatment
Group 2: Standard follow-up care without Tarlatamab
Step 4
Treatment period
If assigned to the Tarlatamab group, you will receive the medication through intravenous infusion
The medication comes as a powder that will be prepared as a solution for infusion
Regular assessments will track your cancer's response to treatment
Your doctor will monitor for any side effects throughout the treatment period
Step 5
Follow-up period
Your cancer will be regularly monitored using imaging scans
Blood tests will be performed to check your overall health and immune response
The treatment will continue until either your disease progresses or you experience unacceptable side effects
Your survival and cancer status will be tracked for up to 2 years

Who can join the trial?

11 criteria

Must be diagnosed with small cell lung cancer confirmed by tissue or cell examination
Must be at least 18 years old when signing consent form
Must have completed chemotherapy or combined chemotherapy and radiation therapy without disease progression
Must have at least one measurable tumor lesion
Must have a life expectancy of at least 3 months
Must be able to perform daily activities with minimal assistance (ECOG status of 0 to 2)
Must have normal heart function with: - No significant heart rhythm abnormalities - Heart pumping strength (ejection fraction) of 50% or higher - No significant fluid around the heart
Must have adequate lung function: - Oxygen level above 90% when breathing room air - No significant fluid in the lungs
Must have adequate blood test results showing: - Sufficient white blood cells (neutrophils) - Sufficient blood platelets - Adequate hemoglobin levels - Normal blood clotting function - Adequate kidney function - Acceptable liver function tests
Must have recovered from previous treatment side effects (except hair loss)
Must voluntarily agree to participate and sign an informed consent form

Who cannot join the trial?

14 criteria

Age under 18 years old
Active brain metastases (cancer that has spread to the brain) or brain disease that requires treatment
History of another type of cancer within the last 3 years, except for successfully treated skin cancer or early-stage cancer
Severe heart conditions including:
- Uncontrolled high blood pressure
- Recent heart attack (within 6 months)
- Unstable heart rhythm problems
- Active, uncontrolled infections requiring treatment
- Known HIV infection, active hepatitis B, or active hepatitis C
- Pregnancy or breastfeeding
- Any condition that, in the opinion of the study doctor, would make participation unsafe
- Current participation in other clinical trials or use of investigational drugs within 30 days before starting this study
- Known allergies to the study medication or its components
- Inability to swallow oral medications
- Major surgery within 4 weeks before starting the study

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Clinico San Carlos
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Madrid, Spain
Hospital De La Santa Creu I Sant Pau
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Barcelona, Spain

Trial locations

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Investigated drugs

Tarlatamab is a medication being studied as a maintenance treatment for small cell lung cancer (SCLC). It is given to patients after they complete a course of sequential chemotherapy and radiation therapy. This medication is designed to help maintain the benefits of initial treatment and potentially prevent or delay the cancer from returning. It is being tested in patients who are not eligible for concurrent chemotherapy and radiation therapy. Chemotherapy and radiation therapy (also called chemo-radiotherapy) is a standard treatment approach that uses anti-cancer drugs along with radiation to kill cancer cells. In this trial, these treatments are given sequentially, meaning one after the other, rather than at the same time.

Tarlatamab

What is already known about the treatment

Tarlatamab – A novel bispecific antibody therapy administered intravenously that is currently being investigated in clinical trials for the treatment of Small Cell Lung Cancer (SCLC), particularly as a maintenance treatment following sequential chemotherapy and radiotherapy. This medication works by simultaneously targeting two specific proteins: DLL3 (found predominantly on SCLC tumor cells) and CD3 (found on T-cells), effectively engaging the patient's immune system to attack cancer cells. Tarlatamab belongs to the class of immunotherapeutic agents and represents a targeted approach to cancer treatment, with ongoing Phase II clinical trials evaluating its efficacy in improving progression-free survival in SCLC patients who are not eligible for concurrent chemoradiotherapy.

Investigated diseases

Small Cell Lung Cancer (SCLC) - A fast-growing type of lung cancer that typically starts in the bronchi, the airways in the center of the chest. The cancer cells are small and oval-shaped when examined under a microscope, which gives the disease its name. SCLC tends to grow and spread more rapidly than other types of lung cancer. The disease usually begins in the lung tissue but can quickly spread to other parts of the body. Early in the disease, cancer cells multiply quickly and form large masses in the lungs.