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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinic De Barcelona Barcelona Spain
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Kepler Universitaetsklinikum GmbH Linz Austria
Centre Hospitalier Universitaire De Nantes Nantes France
University Hospital Olomouc Olomouc Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Injoytvi Rvbrvgpg Dq Cdybas Da Mavciaynvco Montpellier France
Uiuyuomflsydzltajbrjh Eiwaq Acp Essen Germany
Ixjlkz Irhbjinp Fjjrhgejjyyjz Otorcpupzjn Rome Italy
Hktqbmmb Uqakohgnluhah Rzmtceio Dj Mvuevc Malaga Spain
Ulywlarprh Hvxpfwwa Cfvbjjs Cologne Germany
Acrrqxddxj Plwffymv Hubblkta Df Mydekchld Marseille France
Uyhivcjjlm Oz Acnqtmz Edegem Belgium
Hqztzqcp Vefc duhohygc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.07.2022
Belgium Belgium
Not recruiting
13.07.2022
Czechia Czechia
Not recruiting
13.07.2022
France France
Not recruiting
13.07.2022
Germany Germany
Not recruiting
13.07.2022
Italy Italy
Not recruiting
13.07.2022
Spain Spain
Not recruiting
13.07.2022
The Netherlands The Netherlands
Not recruiting
13.07.2022

Trial locations

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.

Tevimbra is an immunotherapy given by infusion. It helps the body’s immune system fight cancer by blocking signals that can hide the cancer from immune cells. In this trial, it is the test treatment being compared with the standard approach.

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 ID:
2024-513185-19-00
Protocol code:
CAAA601A42101
NCT ID:
NCT05142696
Trial Phase:
Human Pharmacology (Phase I) – Other

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