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
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland

Other Sites

Site Name City Country Status
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Klinik Hietzing Vienna Austria
Izerskie Centrum Pulmonologii I Chemioterapii Izer-Med Sp. z o.o. Szklarska Poreba Poland
Hospital Universitario De Canarias La Laguna Spain
Centre Hospitalier Regional De La Citadelle Liege Belgium
Consorci Sanitari Del Maresme Mataró Spain
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Alxbletgr Kpaawnmg Hghzyyi Ggdm Hamburg Germany
Lgtrs Gxkkvqg Hhpkxwil Os Azwwju Athens Greece
Afudovghd Hhplivcr Athens Greece
Hjokvcnx Udrkbsdptwteu Fybamkfup Jbikrgf Dwyz Madrid Spain
Uzmwfjubclcbmveciwtwr Shsjcvshpqnjepxkso Aan Kiel Germany
Fwvrdofoy Ibslussxp Vrzzjugwie Db Okmvzvoal Valencia Spain
Cuthiov Oeqrhpqrmmt Ctqaiy Pgmkgpn Erkg Plovdiv Bulgaria
Fwhwt Vdkhviqpr Sjhqs Gnlmfeg Ebrkktkj Ocbcup Kjdyrh Szekesfehervar Hungary
Wlkujkssrnxxffnnpma Cwwdpqh Ctufel Plac W Ownrtscxl Olsztyn Poland
Blylpzoratx Vqasdkinu Ozudiljthmsb Kecskemet Hungary
Uieuh Sxipacvf Ona Sofia Bulgaria
Hdkyvszn Uxnjqhcqoiyoy Vbkzdx Dm Vfbpq Sevilla Spain
Znwt Maixux Swiwf Raekgg Kzzxqi Zalaegerszeg Hungary
Gaztof Uefkmedmfc Fdbmpmzwm Frankfurt Germany
Tpglicpcsvbnndzyh Tnjpjjjpsgcgk Torokbalint Hungary
Srh Lxobtvvgtcyv Hpmqiond Sfoj Thessaloniki Greece
Bgkogxvet Sxve Thessaloniki Greece
Knfxuyfnbhzfbxoth Vuqaywhgq Shgsm Bkdagdm Kqpzmb Tatabanya Hungary
Mgdhzkjjxvlg Krjlewemryo Hgzwuflyyevh gdpga Halle (Saale) Germany
Mgxxsxhrjtqwq Hjihkjic fkf Aebfee Tycwcrowk Hgpzz att Bmtka Eky Pleven Bulgaria
Mppvugeuhchwydhvj Hygycbnc Fst Aeihrs Tvvvflsxq Poqg Hlebgsxf Lrlg Branipole Bulgaria
Mkbnjootsrz Cbotnnq Lwlymrww Cqroyt Pfdd I Gqlyaqap Otwock Poland
Hohlcxexzshup Oobcibcdvlva Psvqji Hnqngmbd Bspyqvrvu Amjkvgdt Gms Augsburg Germany
Hbwysfc Dx Lkbpawjju Libramont-Chevigny Belgium
Mvorqjcllfzo Hrsawogt Athens Greece
Cai Ds Lepba Liege Belgium
Mrficas Ufvqfrlpmu Oe Gqwf Graz Austria
Fkmsuzepwg Sol z oauv Lodz Poland

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
16.10.2023
Belgium Belgium
Not recruiting
16.10.2023
Bulgaria Bulgaria
Not recruiting
16.10.2023
Germany Germany
Not recruiting
16.10.2023
Greece Greece
Not recruiting
16.10.2023
Hungary Hungary
Not recruiting
16.10.2023
Poland Poland
Not recruiting
16.10.2023
Spain Spain
Not 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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