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Study comparing tarlatamab with topotecan in patients with relapsed small cell lung cancer after first-line chemotherapy

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study focuses on treating Small Cell Lung Cancer (SCLC) that has returned after initial treatment with platinum-based chemotherapy. The study compares two treatment approaches: a new medication called tarlatamab versus standard care treatments that include topotecan, dexamethasone, tocilizumab, and siltuximab. The purpose is to determine if tarlatamab helps patients live longer compared to standard treatments.

Tarlatamab is given through an intravenous infusion, which means it is delivered directly into a vein. The standard care medications may be given either as infusions into a vein or as oral capsules, depending on the specific medication. During treatment, doctors will monitor how well the medications work and track any changes in the cancer.

Throughout the study, healthcare providers will assess various aspects of participants' health, including chest pain, coughing, breathing difficulties, and overall well-being. They will also monitor how the disease responds to treatment and track how long participants survive after starting treatment. The study medication or standard care will be continued as long as it provides benefit to the participant and is well tolerated.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and assignment

    Your eligibility for the study will be evaluated based on specific criteria, including confirmation of small cell lung cancer that has returned or progressed after platinum-based treatment.

    If eligible, you will be randomly assigned to receive either tarlatamab or standard care treatment.

  2. Step 2

    Treatment administration

    You will receive treatment through intravenous infusion (medication given directly into a vein).

    The treatment will be either tarlatamab or one of the standard care medications (topotecan, dexamethasone, tocilizumab, or siltuximab).

    The treatment will continue until your disease progresses or other stopping criteria are met.

  3. Step 3

    Regular assessments

    Your health status will be evaluated every 6 weeks for the first 18 weeks.

    Assessments will include monitoring of chest pain, cough, chest tightness, and your overall physical function.

    Regular scans will be performed to check if your disease has progressed.

  4. Step 4

    Long-term follow-up

    Your health status will continue to be monitored throughout the study period.

    The study is expected to continue until March 2028.

    Your participation will help evaluate how well tarlatamab works compared to standard treatments in extending survival time.

Who can join the trial?

8 criteria

  • Must be able to provide informed consent to participate in the study
  • Must be at least 18 years old or meet the legal adult age requirement in your country (whichever is higher)
  • Must have confirmed small cell lung cancer that has returned or worsened after previous treatment
  • Must have had disease progression or recurrence after receiving one platinum-based treatment (a specific type of chemotherapy)
  • Must have measurable disease that can be evaluated through imaging within 21 days before starting the study
  • Must have good physical functioning ability, scoring either 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work) on the ECOG scale
  • Must have a life expectancy of at least 12 weeks
  • Must have adequate organ function (meaning your major organs are working well enough to participate safely)

Who cannot join the trial?

13 criteria

  • Prior treatment with any DLL3-targeted therapy (a specific type of targeted cancer treatment)
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • History of another cancer within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable angina (chest pain)
    • Severe heart failure
    • Active, uncontrolled infections requiring systemic treatment
    • Known positive test for HIV, active hepatitis B, or active hepatitis C
    • Pregnant or breastfeeding women
    • Any serious medical condition that could interfere with study participation
    • Participation in another clinical trial within 30 days before starting this study
    • Known allergic reactions to similar medications used in this study
    • Significant psychiatric disorders that could affect ability to comply with the study protocol
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Investigated drugs

  • Tarlatamab

    is an investigational medication being studied for treating small cell lung cancer in patients whose cancer has returned after initial platinum-based chemotherapy. It is a targeted therapy designed to find and attack cancer cells. The medication is being compared to standard treatments currently used for this type of cancer.

  • Standard of Care (SOC)

    refers to the current best available treatments that doctors typically use to treat small cell lung cancer after initial chemotherapy has failed. These may include various approved chemotherapy medications that are already established as treatment options for this condition.

What is already known about the treatment

Tarlatamab - An investigational bispecific antibody medication administered through intravenous infusion, specifically designed for treating small cell lung cancer (SCLC) in patients who have experienced disease progression after platinum-based chemotherapy. This novel therapy is currently being evaluated in Phase 3 clinical trials, where it is being compared to standard treatment options to assess its impact on overall survival rates. The medication works by simultaneously targeting two different proteins - one on cancer cells and one on immune cells - helping the body's immune system to recognize and attack cancer cells more effectively, representing a new approach in immunotherapy for SCLC treatment.

Investigated diseases

Small Cell Lung Cancer (SCLC) - A fast-growing type of lung cancer that develops in the lungs' small cells, typically in the bronchi. It is characterized by rapid cell division and early spread throughout the body. The cancer cells are smaller in size than most other types of lung cancer cells, which gives the disease its name. SCLC typically starts in the airways of the lungs and can spread quickly to other parts of the body. The condition often develops in people with a history of smoking.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502669-14-00Protocol code20210004Estimated enrolment525 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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