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A Phase III Randomized Trial of Trilaciclib Dihydrochloride versus Placebo in Adults with Limited‑Stage 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

Limited-stage small cell lung cancer is a fast‑growing cancer that starts in the lungs and has not spread widely. Standard treatment usually combines chemotherapy (medicine that kills cancer cells) with radiation therapy (high‑energy beams that target the tumor). In this study the drug trilaciclib is given by a short intravenous (IV) infusion before each chemotherapy session, and it is compared with a harmless liquid called placebo.

The main goal of the trial is to find out whether adding trilaciclib can lower the chance of myelosuppression, which means a drop in the blood cells that help fight infection and stop bleeding. Participants will receive the usual chemoradiotherapy and, depending on random assignment, either the study drug or the placebo before each chemotherapy cycle. The study follows participants through several treatment cycles, with regular visits for blood tests, imaging scans, and questionnaires about health and well‑being.

During the trial, patients will have routine checks that include blood work to monitor cell counts, scans to see how the tumor is responding, and assessments for any side effects such as infections, need for blood transfusions, or hospital stays. Information on how well the cancer responds and on quality‑of‑life measures will also be collected, allowing researchers to compare outcomes between the two groups.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomisation and assignment

    After joining the study you are randomly assigned to receive either trilaciclib or a placebo solution. the pharmacy prepares the infusion so that you and the study staff do not know which one you receive.

  2. Step 2

    Baseline assessments

    Before any treatment you undergo standard checks such as medical history, performance status, blood tests, heart rhythm recording (electrocardiogram), and other safety measurements.

  3. Step 3

    First treatment cycle (cycle 1)

    On day 1 you receive an iv infusion of the assigned product. if you are in the active group the infusion contains trilaciclib at a dose of 240 mg per square meter of body‑surface area. the placebo group receives an equal volume of 0.9 % sodium chloride solution or 5 % dextrose in water.

    Immediately after the infusion you begin the scheduled chemotherapy and concurrent radiotherapy for limited‑stage small cell lung cancer.

  4. Step 4

    Monitoring during cycle 1

    Blood samples are taken on day 10 and day 17 to check for low white‑blood‑cell counts (severe neutropenia) and other laboratory values.

    Any need for dose reductions, hospital stays, or use of growth‑factor medicines (such as G‑CSF) is recorded.

  5. Step 5

    Subsequent treatment cycles (cycles 2‑4)

    The same sequence is repeated for cycles 2, 3 and 4: on day 1 of each cycle you receive the same iv infusion (either trilaciclib 240 mg/m² or placebo) before chemotherapy and radiotherapy.

    Blood tests are again performed on day 10 and day 17 of each cycle to monitor neutropenia, need for dose adjustments, hospitalisations, and use of supportive medications.

    The study also records any interruptions of radiotherapy, occurrences of fever with low neutrophil counts, and any transfusions of red blood cells or platelets.

  6. Step 6

    End‑of‑treatment evaluation

    After completing cycle 4 a final assessment is performed. imaging studies are used to evaluate tumour response according to the RECIST criteria, and quality‑of‑life questionnaires (FACT‑L and FACT‑An) are completed.

    Safety checks such as blood work, vital signs, and heart rhythm recordings are repeated.

  7. Step 7

    Follow‑up visit

    Approximately 90 days after the last treatment you return for a follow‑up visit. safety labs, performance status, and the quality‑of‑life questionnaires are collected to assess any late effects of the study treatments.

Who can join the trial?

16 criteria

  • Women and men who are **18 years of age or older**.
  • A confirmed diagnosis of **small cell lung cancer** made by examining tissue (called **histology**) or cells (called **cytology**) and staging that shows the cancer is **limited stage** (stages I‑III) with no spread to distant parts of the body; limited stage is defined by standard cancer‑staging systems (VALSG or AJCC/UICC).
  • An **ECOG performance status** of **0 or 1**, meaning you are fully active (0) or able to do light work (1).
  • Eligibility to receive **concurrent chemoradiotherapy (CRT)**, which means chemotherapy and radiation treatment given at the same time.
  • Having disease that can be **measured or evaluated** according to the **RECIST 1.1** guidelines, a standard method doctors use to track tumor size.
  • Having adequate organ function shown by lab results:
    • **Hemoglobin (Hb)** ≥ 9 g/dL (a measure of the blood’s ability to carry oxygen).
    • **Absolute neutrophil count (ANC)** ≥ 1.5 × 10⁹/L (a type of white blood cell that fights infection).
    • Platelet count ≥ 100 × 10⁹/L (cells that help blood clot).
    • Kidney function **eGFR** ≥ 60 mL/min/1.73 m² (how well the kidneys filter blood).
    • Total bilirubin ≤ 1.5 × upper limit of normal (**ULN**) (or ≤ 3 × ULN if you have Gilbert’s disease, a mild liver condition).
    • Liver enzymes **ALT** and **AST** ≤ 2.5 × ULN (tests that show liver health).
    • Albumin ≥ 3 g/dL (a protein that reflects overall nutrition and liver function).
    • No red‑blood‑cell‑boosting medication (**ESA**) or blood transfusion within the 14 days before the first study dose.
    • Complete recovery from any previous cancer‑removing surgery.
    • Agreement to use birth‑control methods as described, or to follow any stricter local requirements for contraception.
    • Willingness to take part in the study and to sign the **informed consent form (ICF)**.

Who cannot join the trial?

13 criteria

  • Having extensive‑stage small cell lung cancer (ES‑SCLC), meaning the cancer has spread beyond the limited stage.
  • Being pregnant or nursing (breast‑feeding) at the time of the study.
  • Receiving a live, attenuated vaccine (a weakened form of a virus or bacteria) within 30 days before the first dose of the study drug, or needing one during the study period. (Regular inactive vaccines such as flu, pneumonia, shingles, or approved COVID‑19 vaccines are allowed.)
  • Having had a stem cell or bone marrow transplant from another person (allogeneic) or from yourself (autologous) before joining the trial.
  • Having any abnormal lab test result, medical problem, or psychiatric disorder that the doctor believes could make disease management unsafe or could prevent you from following the study requirements.
  • Having previously been treated with the chemotherapy drugs cisplatin, carboplatin, etoposide or the study drug trilaciclib for small cell lung cancer.
  • Receiving any cancer treatment (chemotherapy, radiation, immunotherapy, biologic, experimental drug, or hormone therapy) within 3 weeks before the first dose, except for certain hormone treatments for early‑stage breast or prostate cancer that are not advanced.
  • Having a history of moderate or severe interstitial lung disease or pneumonitis (lung inflammation) that was grade 2 or higher, unless it was an infection that has fully resolved.
  • Having a history of other cancers, unless they were solid tumors that were cured with no evidence of disease for at least 2 years, or non‑serious skin cancers (basal or squamous cell) or early‑stage cervical cancer.
  • Having active cardiovascular disease at the time of signing the consent, such as a stroke or mini‑stroke (cerebrovascular accident) within the past 6 months, a heart attack (myocardial infarction) within the past 6 months, unstable chest pain (unstable angina), serious irregular heartbeat (cardiac arrhythmia) that needs medication, or uncontrolled heart failure symptoms (class II or higher as defined by the NYHA classification).
  • Having a heart‑electric measurement called the QTcF interval longer than 480 milliseconds on screening (or longer than 500 ms if you have a ventricular pacemaker), confirmed by a repeat test.
  • Having a serious current infection such as HIV, hepatitis B, hepatitis C, or tuberculosis.
  • Being allergic or having a severe reaction (hypersensitivity) to trilaciclib, cisplatin, carboplatin, etoposide or any of their ingredients.
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Investigated drugs

Trilaciclib is an intravenous drug that is given to patients before they receive chemotherapy and radiation for limited‑stage small cell lung cancer. Its purpose in the trial is to see if it can protect the bone marrow, helping to reduce the drop in blood cells (myelosuppression) that often occurs during cancer treatment. By potentially keeping blood counts higher, the drug may allow patients to stay on their cancer therapy with fewer interruptions or dose reductions. The study compares patients who receive trilaciclib with those who receive a placebo to determine how well it works and how safe it is.

What is already known about the treatment

TRILACICLIB DIHYDROCHLORIDE - This medication is supplied as a powder that is mixed with liquid and given by IV infusion, usually over a short period before chemotherapy. It is an approved drug used to help protect the bone marrow of patients with limited‑stage small cell lung cancer who are receiving chemoradiation. Trilaciclib works by briefly blocking a protein called CDK4/6, which pauses the growth of blood‑forming cells so they are less likely to be damaged by chemotherapy. It belongs to the class of CDK4/6 inhibitors and is considered a myeloprotective agent.

Investigated diseases

Limited-stage small cell lung cancer (LS-SCLC) - Limited-stage small cell lung cancer is a rapidly growing cancer that starts in the small cells lining the airways of the lung. It is confined to one side of the chest and may involve nearby lymph nodes but has not spread to distant organs. The tumor can enlarge quickly, causing symptoms such as cough, shortness of breath, and chest discomfort. As the disease progresses, cancer cells may infiltrate surrounding lung tissue and the pleura. Without control, it can advance to extensive-stage disease, spreading to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525026-35-00Protocol codeTrilaciclib-LSSCLC01Estimated enrolment112 patientsSponsorPharmacosmos A/S

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