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Study of Lutetium (177Lu) Oxodotreotide, Carboplatin, Etoposide, and Atezolizumab in Newly Diagnosed Extensive Stage Small Cell Lung Cancer Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is studying extensive stage small cell lung cancer, a fast-growing type of lung cancer that has already spread widely in the body. The study is testing Lutathera (lutetium (177Lu) oxodotreotide) given together with carboplatin, etoposide, and atezolizumab during the first part of treatment, and then with atezolizumab alone during the later treatment phase. The purpose of the study is to find the best dose of Lutathera and to see whether adding it may help people live longer. In the first part of the study, people receive the treatment combination and the dose is adjusted to find a suitable amount. In the second part, one group receives Lutathera with the standard treatment, while another group receives the standard treatment without Lutathera. Treatment is given over several visits, with follow-up after treatment to see how the disease and treatment effects change over time.

Some people in the study may also receive NETSPOT (dotatate) for a special body scan, and LysaKare (arginine hydrochloride, lysine hydrochloride) may be given to help protect the kidneys during treatment with Lutathera. The study also includes checks for side effects and general safety, and treatment may be stopped or changed if the medicine is not tolerated. This trial is focused on newly diagnosed extensive stage small cell lung cancer and uses a combination of cancer medicine, immune treatment, and a targeted radioactive medicine.

The research process

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

  1. Step 1

    <b>trial start</b>

    After joining the study, you enter a treatment plan for newly diagnosed extensive stage small cell lung cancer (ES-SCLC), which is a fast-growing lung cancer that has spread widely.

    You are placed into one of the study groups. In the experimental arm, you receive [177Lu]Lu-DOTA-TATE together with carboplatin, etoposide, and atezolizumab. In the control arm, you receive carboplatin, etoposide, and atezolizumab without [177Lu]Lu-DOTA-TATE.

  2. Step 2

    <b>induction treatment</b>

    During the first treatment phase, called induction treatment, you receive the study medicines by intravenous infusion, which means they are given through a vein.

    The medicines used in this phase are carboplatin, etoposide, and atezolizumab. In the experimental arm, [177Lu]Lu-DOTA-TATE is also given.

    carboplatin is given by intravenous infusion. etoposide is given by intravenous administration. atezolizumab is given by intravenous infusion. [177Lu]Lu-DOTA-TATE is given by intravenous infusion.

    The study text does not state the exact dose, frequency, or total duration for these medicines.

  3. Step 3

    <b>maintenance treatment</b>

    After induction treatment, you may move into the maintenance treatment phase.

    In this phase, you receive atezolizumab by intravenous infusion. In the experimental arm, [177Lu]Lu-DOTA-TATE is used in combination with atezolizumab in the maintenance phase.

    The study text does not state the exact dose, frequency, or total duration for these medicines.

  4. Step 4

    <b>study assessments</b>

    During the study, your response to treatment is checked, including whether the cancer shrinks, stays controlled, or gets worse.

    The study also measures side effects, including serious side effects and side effects that may lead to stopping treatment.

    In the experimental arm, the study measures how [177Lu]Lu-DOTA-TATE is distributed in the body, how much of it is in the blood over time, how much leaves the body in urine, and how much radiation reaches organs and tumor areas.

    The study also checks side effects that happen within 48 hours after [68Ga]Ga-DOTA-TATE infusion. [68Ga]Ga-DOTA-TATE is a radioactive tracer used for scanning, given by infusion.

  5. Step 5

    <b>end of study participation</b>

    Your study participation ends after the treatment and follow-up assessments described in the study.

    The study text gives no additional stage details beyond treatment, assessment, and study end.

Who can join the trial?

7 criteria

  • Be at least 18 years old on the day you sign the consent form, which is the document that says you agree to join the study.
  • Have extensive-stage small cell lung cancer confirmed by a histology test or a cytology test, meaning the cancer was proven by looking at tissue or cells under a microscope.
  • Have at least one measurable tumor, meaning there is at least one spot of cancer that can be measured on a CT scan. A CT scan is an imaging test that uses X-rays to make detailed pictures of the body.
  • Have at least one tumor area that is SSTR positive on a 68Ga-DOTA-TATE PET scan, meaning the scan shows strong enough uptake of the tracer, at least as much as the liver. A PET scan is an imaging test that shows how body tissues are working.
  • Have had no previous systemic treatment for this lung cancer, except possibly the first cycle of treatment during the induction period. Systemic treatment means treatment that travels through the whole body, such as chemotherapy or immunotherapy.
  • Provide a tumor tissue sample for extra research tests called biomarker analysis, which looks for signs in the tumor that may help study the treatment.
  • Have a life expectancy of at least 6 months, meaning the doctor expects the person is likely to live for at least that long.

Who cannot join the trial?

7 criteria

  • Having had previous treatment with a medicine that targets the immune checkpoint pathway, which is a treatment that helps the immune system attack cancer.
  • Having active leptomeningeal disease, meaning cancer cells are present in the thin layers that cover the brain and spinal cord.
  • Having brain metastases that are untreated or not under control, meaning cancer has spread to the brain and is still causing problems.
  • Having had a major surgery that needed general anesthesia within 28 days before Cycle 2 Day 1. General anesthesia means medicine was used to make the person fully asleep during surgery.
  • Having a current history of ECG abnormalities that create a significant safety risk. An ECG, or electrocardiogram, is a test that records the heart’s electrical activity.
  • Having a known allergy or strong bad reaction to any of the study medicines or to any of their ingredients.
  • Taking part in another treatment clinical study at the same time.
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Investigated drugs

  • Lutathera

    is a targeted radiopharmaceutical treatment given by infusion. It carries a small amount of radiation that is designed to go to cancer cells with a certain receptor on their surface, helping treat the tumor from the inside. In this trial, it is the main study treatment being tested together with standard cancer medicines.

  • Atezolizumab

    is an immunotherapy given by infusion. It helps the immune system recognize and attack cancer cells more effectively. In this study, it is part of both the main treatment plan and the standard treatment used after the first phase of therapy.

  • Carboplatin

    is a chemotherapy medicine given by infusion. It works by damaging cancer cells so they can no longer grow and divide normally. In this trial, it is part of the standard treatment given along with other cancer medicines.

  • Etoposide

    is a chemotherapy medicine given by infusion. It helps kill cancer cells by stopping them from multiplying. In this study, it is used together with other treatments during the first phase of treatment.

  • LysaKare

    is an amino acid infusion used as supportive treatment. It is given to help protect the kidneys when the radiopharmaceutical treatment is administered, so that more of the radioactive medicine can be safely used and less reaches the kidneys.

  • NETSPOT

    is the study radiopharmaceutical kit used to prepare a dotatate-based imaging agent. It is used for diagnostic imaging, not as a placebo, and helps doctors look for tumors that have the right target for this type of treatment.

What is already known about the treatment

  • Arginine hydrochloride / lysine hydrochloride

    This medicine is given as a solution for infusion into a vein. It is used in medicine mainly as a protective add-on treatment during certain nuclear medicine therapies, especially to help reduce radiation exposure to the kidneys and other nearby tissues. Arginine and lysine are small building blocks of proteins; at the molecular level, they help block the uptake of the radioactive drug by healthy kidney cells, lowering the amount that stays in the body. It is classified as an amino acid-based kidney-protective agent used in supportive care.

  • Dotatate

    This medicine is used as a kit for intravenous preparation of a radiopharmaceutical and is given by vein after it is combined with a radioactive label. It is well known in medical literature as part of diagnostic scans and targeted radionuclide therapy for tumors that carry somatostatin receptors, especially neuroendocrine tumors and related cancers. Dotatate binds strongly to these receptors on cancer cells, allowing the attached radioactive part to deliver radiation directly to the tumor. It is classified as a somatostatin receptor-targeting peptide and a radiopharmaceutical.

  • Atezolizumab

    This medicine is given as an intravenous infusion. It is an established cancer medicine widely used in modern oncology and well described in medical literature for several types of cancer, including lung cancer. It works by blocking a protein called PD-L1, which helps cancer cells hide from the immune system, so immune cells can recognize and attack the tumor more easily. It is classified as an immune checkpoint inhibitor and a monoclonal antibody.

  • Carboplatin

    This medicine is given as an intravenous infusion. It is a long-established chemotherapy drug used in many cancers, including lung cancer, and it remains an important part of standard cancer treatment. At the molecular level, it damages the DNA of cancer cells, which stops them from growing and dividing. It is classified as a platinum-based anticancer drug.

  • Tislelizumab

    This medicine is given as an intravenous infusion. It is a newer cancer medicine that is already used in clinical practice and has growing support in medical literature for several cancers. It blocks the PD-1 signal on immune cells, which helps the immune system stay active against cancer cells instead of being switched off by the tumor. It is classified as an immune checkpoint inhibitor and a monoclonal antibody.

  • Etoposide

    This medicine is given by intravenous infusion. It is a well-established chemotherapy drug used for many cancers, including small cell lung cancer, and has been part of cancer care for many years. It works by blocking an enzyme that cancer cells need to copy and repair their DNA, which leads to cell death. It is classified as a topoisomerase inhibitor and a chemotherapy medicine.

Investigated diseases

Extensive-stage small cell lung cancer - A fast-growing type of lung cancer that begins in small cells lining the airways and usually spreads early to other parts of the body. It typically develops and progresses quickly, with cancer cells multiplying rapidly and forming tumors in the lung and beyond.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513185-19-00Protocol codeCAAA601A42101Estimated enrolment138 patientsSponsorNovartis Pharma AG

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