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Study of Lurbinectedin and Atezolizumab for Maintenance Therapy in Patients with Extensive-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

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 investigating the effects of two treatments: lurbinectedin and atezolizumab. Atezolizumab, also known by its code name RO5541267, is a medication that is already used in treating this type of cancer. Lurbinectedin, with the code name RO7508182, is being tested in combination with atezolizumab to see if it can improve outcomes for patients.

The purpose of the study is to compare the effectiveness of using lurbinectedin together with atezolizumab against using atezolizumab alone as a maintenance therapy. Maintenance therapy is a treatment given to help keep cancer from coming back after it has responded to initial treatment. Participants in the study will have already received a first round of treatment with atezolizumab, carboplatin, and etoposide, which are standard drugs used to treat ES-SCLC.

During the study, participants will be randomly assigned to receive either the combination of lurbinectedin and atezolizumab or atezolizumab alone. The study will monitor how long participants live without their cancer getting worse and their overall survival. The trial will also look at the safety of the treatments and any side effects that may occur. This study aims to provide more information on whether the combination of these drugs can offer better outcomes for patients with this type of lung cancer.

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

    Joining the study

    Upon joining the study, participation is confirmed for individuals with extensive-stage small-cell lung cancer (ES-SCLC) who meet specific criteria, such as having a confirmed diagnosis and adequate organ function.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving a combination of lurbinectedin and atezolizumab, and the other receiving atezolizumab alone as maintenance therapy.

  3. Step 3

    Treatment administration

    The treatment involves intravenous infusion of the medications. Atezolizumab is administered as a 1,200 mg concentrate for solution, while lurbinectedin is also given via infusion. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess the progression-free survival and overall survival. This includes evaluations by an independent review facility and investigators using specific criteria.

  5. Step 5

    Evaluation of treatment response

    The response to treatment is evaluated based on progression-free survival, overall survival, and other measures such as objective response rate and duration of response.

  6. Step 6

    Adverse events monitoring

    The incidence and severity of any adverse events are closely monitored, with severity determined according to established criteria.

  7. Step 7

    Completion of study

    The study is estimated to conclude by March 2026, with ongoing assessments and data collection throughout the trial period.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of **Small-Cell Lung Cancer (SCLC)**, which is a type of lung cancer.
  • Must have **adequate hematologic and end-organ function**, meaning the blood and organs are working well enough.
  • Must have an **ECOG PS** of 0 or 1, which is a scale used to measure how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Must not have had any prior **systemic treatment** for **ES-SCLC**, which means no previous treatments that affect the whole body for this type of cancer.
  • Must have an ongoing response or stable disease according to **RECIST v1.1**, which is a set of rules to measure how well a cancer treatment is working.
  • Any side effects from previous cancer treatments or **PCI** (a type of brain radiation) must have improved to a mild level, known as **Grade 1** or better.
  • Both males and females can participate.
  • Participants can be from a vulnerable population, meaning they might need extra protection or care.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer other than Small-Cell Lung Cancer (SCLC) cannot participate. SCLC is a specific type of lung cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have not recovered from major surgery or a serious illness cannot participate.
  • Patients who have a history of drug or alcohol abuse that might affect the study cannot participate.
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Investigated drugs

  • Lurbinectedin

    is a medication being studied for its potential to treat extensive-stage small-cell lung cancer. It is being tested in combination with another medication to see if it can help improve the outcomes for patients who have already received initial treatment.

  • Atezolizumab

    is an immunotherapy drug that helps the body's immune system fight cancer cells. In this study, it is used both alone and in combination with lurbinectedin to see how effective it is in maintaining the health of patients with extensive-stage small-cell lung cancer after they have received their first round of treatment.

  • Carboplatin

    is a chemotherapy drug that is used to kill cancer cells. It is part of the initial treatment given to patients in this study before they receive maintenance therapy.

  • Etoposide

    is another chemotherapy medication used alongside carboplatin in the initial treatment phase. It works by preventing cancer cells from dividing and growing.

What is already known about the treatment

  • Lurbinectedin

    Lurbinectedin is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating extensive-stage small-cell lung cancer (ES-SCLC). It is being evaluated in combination with atezolizumab, a known cancer immunotherapy. Lurbinectedin works by binding to the DNA in cancer cells, disrupting their ability to replicate and ultimately leading to cell death. It is classified as an antineoplastic agent, specifically a DNA-binding agent.

  • Atezolizumab

    Atezolizumab is given as an intravenous infusion and is an established medication in the treatment of various cancers, including small-cell lung cancer. It is used as a maintenance therapy in combination with other drugs like lurbinectedin. Atezolizumab functions by inhibiting the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It belongs to the class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Small-Cell Lung Cancer (SCLC) – This is a fast-growing type of lung cancer that primarily arises in the bronchi, the main airways of the lungs. It is characterized by small cells that multiply quickly and form large tumors. SCLC often spreads rapidly to other parts of the body, including the lymph nodes, liver, bones, adrenal glands, and brain. The disease is strongly associated with smoking and is less common than non-small cell lung cancer. Symptoms may include coughing, chest pain, shortness of breath, and weight loss. Due to its aggressive nature, SCLC is often diagnosed at an advanced stage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503868-16-00Protocol codeGO43104Estimated enrolment658 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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