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

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What is this trial about?

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

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.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

11 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

IDP-121 – IDP-121 is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is being tested in combination with standard chemotherapy drugs (topotecan, carboplatin, and etoposide) for the treatment of small cell lung cancer that has returned after previous treatment or has spread to other parts of the body. The drug is administered as part of a combination therapy regimen, where researchers are working to find the safest and most effective dose that can be given to patients. The specific way IDP-121 works at the molecular level and its exact mechanism of action are still being investigated as part of this early-phase clinical trial.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521902-17-00Protocol codeIDP-121-2 MYCrocyticEstimated enrolment60 patientsSponsorIdp Discovery Pharma S.L.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).