Study of IDP-121 with chemotherapy for patients with relapsed small cell lung cancer

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What is this study about?

This study is looking at small cell lung cancer that has spread or cannot be removed by surgery and has come back after previous treatment. The study will test a medicine called IDP-121 given together with standard chemotherapy drugs. There are two treatment groups in this study. One group will receive IDP-121 combined with topotecan, which is a chemotherapy drug given on days 1 through 5 every 3 weeks. The other group will receive IDP-121 combined with two chemotherapy drugs called carboplatin and etoposide. In this second group, carboplatin is given on day 1 and etoposide is given on days 1, 2, and 3 every 3 weeks. The choice of which treatment group a patient joins depends on how long it has been since their cancer started growing again after the first treatment they received.

The purpose of this study is to find out the best dose of IDP-121 when it is given with chemotherapy and to see how well this combination works in treating small cell lung cancer that has come back. The study has two parts. In the first part, different doses of IDP-121 will be tested to find the highest dose that can be given safely and the best dose to use in the second part of the study. In the second part, more patients will receive the chosen dose of IDP-121 with chemotherapy to learn more about how well it works in shrinking or controlling the cancer.

During the study, patients will receive IDP-121 as an infusion into a vein along with their chemotherapy treatment. The study will check how patients respond to the treatment by looking at whether the cancer shrinks, stays the same, or grows. Doctors will also monitor patients for any side effects and will perform regular tests including blood tests, heart function tests using echocardiogram, physical examinations, and electrocardiograms to check the electrical activity of the heart. The study will also measure how long the treatment keeps working if the cancer responds and how long patients live.

1 Treatment Assignment

Upon joining the study, your treatment will be assigned based on your disease characteristics. If your cancer progressed 3 months or more after your first treatment ended, you will receive carboplatin plus etoposide combined with IDP-121. If your cancer progressed in less than 3 months, you will receive topotecan combined with IDP-121.

2 Treatment Cycle Structure

The treatment is organized in cycles. Each cycle lasts 21 days (3 weeks). The number of cycles you receive will depend on how your body responds to the treatment and whether you experience any side effects.

3 Medication Administration – Topotecan Arm

If you are assigned to the topotecan treatment arm, you will receive topotecan on days 1 through 5 of each 21-day cycle. This medication will be given through an infusion into your vein.

You will also receive IDP-121 during this cycle. IDP-121 is given as an infusion into your vein. The specific dose and schedule will be determined during the study.

4 Medication Administration – Carboplatin and Etoposide Arm

If you are assigned to the carboplatin and etoposide treatment arm, you will receive carboplatin on day 1 of each 21-day cycle. This medication will be given through an infusion into your vein.

You will receive etoposide on days 1, 2, and 3 of each 21-day cycle. This medication will also be given through an infusion into your vein.

You will also receive IDP-121 during this cycle. IDP-121 is given as an infusion into your vein. The specific dose and schedule will be determined during the study.

5 Safety Monitoring During First Cycle

During the first 21 days of treatment, you will be closely monitored for any side effects. This initial period is important to determine the appropriate dose of IDP-121 for future treatment.

6 Regular Medical Assessments

Throughout the study, you will undergo regular medical assessments. These include physical examinations to check your overall health and how you are tolerating the treatment.

Your vital signs will be measured regularly. This includes your blood pressure, heart rate, temperature, and breathing rate.

7 Laboratory Tests

Blood tests will be performed regularly to monitor your blood cell counts, including red blood cells, white blood cells, and platelets.

Additional blood tests will check your liver and kidney function, as well as other important body chemistry levels.

Urine tests will also be conducted as part of the safety monitoring.

8 Heart Monitoring

Electrocardiograms will be performed to monitor your heart’s electrical activity. This test records the rhythm and electrical signals of your heart.

Your heart function will be assessed to ensure it remains within safe levels throughout the treatment.

9 Tumor Response Assessment

Imaging scans will be performed at regular intervals to evaluate how your cancer is responding to the treatment. These assessments will determine whether the tumor is shrinking, staying the same size, or growing.

10 Continuation of Treatment Cycles

If the treatment is working and you are tolerating it well, you will continue receiving additional 21-day cycles. Each cycle will follow the same medication schedule based on your assigned treatment arm.

11 End of Treatment

Treatment will continue until your cancer progresses, you experience unacceptable side effects, or you decide to stop participating in the study.

After treatment ends, you will continue to be monitored for your overall health status and survival.

Who Can Join the Study?

You must be 18 years of age or older
You must have been diagnosed with advanced or extensive stage small cell lung cancer, which is a type of lung cancer that has spread beyond the lungs
Your cancer must have come back after your first line treatment, which means the initial chemotherapy you received
You must have received platinum-based chemotherapy previously, which is a type of cancer treatment using platinum-containing drugs
Your performance status must be 2 or less on a scale that measures how well you can perform daily activities
Your expected survival time must be at least 2 months
Your hemoglobin level must be greater than 8.0 grams per deciliter without needing blood transfusions in the past 7 days. Hemoglobin is a protein in red blood cells that carries oxygen
Your platelet count must be greater than 100,000 per microliter without needing transfusions in the past 7 days. Platelets are blood cells that help with clotting
Your absolute neutrophil count must be greater than 1,500 per microliter without needing growth factor support in the past 7 days. Neutrophils are white blood cells that fight infection
Your liver function tests must show that your AST and ALT levels are less than 2.5 times the upper normal limit. These are enzymes that indicate how well your liver is working
Your total bilirubin must be less than 2 times the upper normal limit. Bilirubin is a substance produced when red blood cells break down, and high levels may indicate liver problems
Your kidney function must show a creatinine clearance of at least 60 milliliters per minute, which measures how well your kidneys filter waste from your blood
Your heart function must show a left ventricular ejection fraction greater than 50 percent or above your hospital’s normal lower limit. This measures how well your heart pumps blood
You must be willing and able to follow all study requirements
You must be able to provide written informed consent, which means you agree to participate after understanding the study

Who Cannot Join the Study?

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this document
Generally, clinical trials may exclude patients based on factors such as other serious medical conditions, recent treatments, or laboratory test results that fall outside safe ranges
Patients who are pregnant or breastfeeding are typically excluded from cancer treatment studies due to potential risks to the baby
People with severe problems in how their kidneys (organs that filter waste from blood) or liver (organ that processes medications) work may not be able to join
Patients with uncontrolled infections or other cancers may be excluded to ensure safety
Those who have had recent major surgery may need to wait before joining the study
Patients taking certain medications that could interfere with the study drugs may not be eligible
People with heart problems or abnormal heart rhythms may be excluded for safety reasons
Patients with brain metastases (cancer that has spread to the brain) that are not stable or controlled may not qualify
Those with allergies to any of the study medications would be excluded
Patients who cannot follow the study requirements or attend regular visits may not be able to participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hjjfwmff Uakzpuuidfydl Hjpdobhc Tatkk y Pizgjl Idxyssvj Cktltj dhaxjodtxsmwljilr (hgzr	Badalona	Spain
Hyckglsn Vraa dsirgwup	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	03.12.2025

Trial locations

Investigated drugs:

IDP-121

IDP-121 is an investigational medication being studied in this trial. It is given in combination with chemotherapy to treat patients with small cell lung cancer that has come back after previous treatment.

Topotecan is a chemotherapy medication used to treat various types of cancer, including small cell lung cancer. It works by stopping cancer cells from growing and dividing.

Carboplatin is a chemotherapy medication that helps fight cancer by damaging the DNA inside cancer cells, which prevents them from multiplying.

Etoposide is a chemotherapy medication that works by blocking an enzyme that cancer cells need to divide and grow, helping to slow down or stop the spread of cancer.

Investigated diseases:

Small cell lung cancer metastatic

Small Cell Lung Cancer – Small cell lung cancer is a type of lung cancer that develops in the tissues of the lungs. It is characterized by small cells that multiply quickly and form large tumors that spread throughout the body. This cancer typically starts in the breathing tubes and grows rapidly compared to other types of lung cancer. The disease often spreads early to other parts of the body, including lymph nodes, bones, brain, and liver. When the cancer cannot be removed by surgery or has spread to distant organs, it is classified as unresectable or metastatic. The disease progresses aggressively and requires prompt medical attention once detected.

Trial ID:

2025-521902-17-00

Protocol code:

IDP-121-2 MYCrocytic

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of IDP-121 with chemotherapy for patients with relapsed small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?