Study on Trilaciclib and Topotecan for Patients with Extensive Stage Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study is evaluating a treatment called Trilaciclib, which is given to patients before they receive a chemotherapy drug named Topotecan. The purpose of the study is to see if Trilaciclib can help patients live longer compared to those who receive a placebo before Topotecan. A placebo is a substance with no active medication, used for comparison in clinical trials.

Participants in the study will receive either Trilaciclib or a placebo before their Topotecan chemotherapy sessions. The study will monitor the overall survival of patients, which means the length of time patients live after starting the treatment. The trial will also look at other factors, such as how the cancer responds to the treatment and any side effects that may occur. The study is designed to last for a period of up to 120 days, during which patients will receive regular intravenous infusions of the study medications.

In addition to Trilaciclib and Topotecan, the study involves the use of other substances like Sodium Chloride and Glucose Monohydrate, which are commonly used in medical settings to support the administration of intravenous treatments. The trial aims to provide valuable information on the effectiveness and safety of using Trilaciclib in combination with Topotecan for treating patients with ES-SCLC.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication trilaciclib or a placebo. This is done to compare the effects of the medication with no active treatment.

You will be informed about the schedule and procedures involved in the study, including the administration of the medication and any necessary follow-up visits.

2 medication administration

The study involves receiving trilaciclib or a placebo through an intravenous infusion. This means the medication is given directly into your vein using a needle.

The infusion is administered prior to receiving topotecan chemotherapy, which is also given through an intravenous infusion. The exact dosage and frequency will be determined by the study protocol and your healthcare provider.

3 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and other assessments to evaluate your response to the treatment and to ensure your safety.

You will be asked to report any side effects or changes in your health to the study team. This information is crucial for understanding the effects of the treatment.

4 completion of the study

At the end of the study period, you will undergo a final evaluation to assess your overall health and the outcomes of the treatment.

The study team will discuss the results with you and provide guidance on any further treatment or follow-up care that may be needed.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Have an ECOG performance status of 0-2, which is a scale used to assess how a disease affects a patient’s daily living abilities.
  • Have adequate organ function as shown by specific laboratory tests.
  • Any side effects from previous treatments must be resolved to a certain level, except for some ongoing side effects like hair loss or nerve damage that are not considered risky for further treatment.
  • Must use contraception as per local guidelines if applicable.
  • Must be able to provide informed consent, meaning you understand and agree to the study’s requirements.
  • Have a confirmed diagnosis of Extensive Stage Small Cell Lung Cancer (ES-SCLC) through specific medical tests.
  • The cancer must have progressed during or after previous chemotherapy treatments.
  • Must have measurable or evaluable disease as defined by specific medical criteria.
  • Must know the sensitivity status to first-line therapy, meaning how the cancer responded to initial treatment.
  • Must be considered eligible to receive topotecan chemotherapy by the study doctor.

Who Cannot Join the Study?

  • Patients who do not have Extensive Stage Small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Koranyi National Institute For Pulmonology Budapest Hungary
Medical University Of Graz Graz Austria
Futuremeds Sp. z o.o. Wroclaw Poland
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland

Other Sites

Site Name City Country Status
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Bioclinic S.A. Thessaloniki Greece
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Haematologie-Onkologie im Zentrum MVZ GmbH Augsburg Germany
Alexandra Hospital Athens Greece
Klinik Hietzing Vienna Austria
St. Luke’s Hospital S.A. Thessaloniki Greece
Izerskie Centrum Pulmonologii I Chemioterapii Izer-Med Sp. z o.o. Szklarska Poreba Poland
Hospital Universitario De Canarias La Laguna Spain
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Consorci Sanitari Del Maresme Mataró Spain
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Hopital De Libramont Libramont-Chevigny Belgium
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Multiprofessional Hospital For Active Treatment Park Hospital Ltd. Branipole Bulgaria
Metropolitan Hospital Athens Greece
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy Otwock Poland
Biuigychlge Vveazlxbw Owvjndivgtfn Kecskemet Hungary
Lzvmi Grvyfrc Hfxptnpa Ok Aolkcv Athens Greece
Gpxvvw Utdxwykczh Fgfeopicb Frankfurt Germany
Ucqej Scgjbjrt Oof Sofia Bulgaria

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
16.10.2023
Belgium Belgium
Recruiting
16.10.2023
Bulgaria Bulgaria
Recruiting
16.10.2023
Germany Germany
Recruiting
16.10.2023
Greece Greece
Recruiting
16.10.2023
Hungary Hungary
Recruiting
16.10.2023
Poland Poland
Recruiting
16.10.2023
Spain Spain
Recruiting
16.10.2023

Trial locations

Trilaciclib is a medication being studied to see if it can help protect the bone marrow from damage caused by chemotherapy. The bone marrow is important because it makes blood cells that help fight infections, carry oxygen, and stop bleeding. In this trial, trilaciclib is given before chemotherapy to see if it can help patients with extensive stage small cell lung cancer live longer.

Topotecan is a type of chemotherapy used to treat small cell lung cancer. It works by stopping cancer cells from growing and dividing. In this study, topotecan is given to patients to see how well it works when used with or without trilaciclib.

Extensive Stage Small Cell Lung Cancer – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called “extensive stage” when the cancer has spread beyond the lung to other parts of the body. The disease progresses rapidly, often involving the liver, bones, and brain. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to weight loss, fatigue, and neurological issues. The progression is typically aggressive, with a tendency to metastasize early in its course.

Trial ID:
2022-502357-34-00
Protocol code:
G1T28-211
Trial Phase:
Therapeutic confirmatory (Phase III)

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