Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Atezolizumab and Chemotherapy for Patients with Relapsed Small Cell Lung Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 small cell lung cancer (SCLC). The study is investigating a treatment that combines a medication called atezolizumab with a standard chemotherapy regimen. Atezolizumab, also known by its code name RO5541267, is a medication that helps the immune system fight cancer by blocking a protein called PD-L1. This study aims to see how effective this combination treatment is for patients whose cancer has returned after initial treatment with chemotherapy and a PD-L1 inhibitor.

The purpose of the study is to explore whether adding atezolizumab to the standard chemotherapy can improve the overall survival of patients with SCLC. Participants in the study will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will follow the participants over a period to monitor their health and the progression of their cancer. Some participants may receive a placebo instead of atezolizumab to compare the effects of the treatment.

Throughout the study, researchers will assess the safety of the treatment by monitoring any side effects experienced by the participants. They will also measure how long the participants live without their cancer getting worse, known as progression-free survival, and the overall response rate, which indicates how well the cancer responds to the treatment. The study is expected to continue for several years to gather comprehensive data on the treatment's effectiveness and safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of small cell lung cancer (SCLC) and a stable medical condition.

    Written informed consent is required before any study-related procedures begin.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of atezolizumab, a medication given as a solution for infusion. This is combined with standard chemotherapy.

    The chemotherapy regimen includes platinum-etoposide, which is a standard treatment for SCLC.

  3. Step 3

    Treatment schedule

    The atezolizumab infusion is administered at regular intervals as part of the treatment plan.

    The exact dosage and frequency are determined by the study protocol and the patient's specific condition.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the patient's response to the treatment and to identify any side effects.

    Assessments include measuring overall survival, progression-free survival, and objective response rate.

  5. Step 5

    Completion of treatment

    The treatment continues until the study's end date or until the patient experiences disease progression or unacceptable side effects.

    The estimated end date for the study is June 1, 2029.

Who can join the trial?

15 criteria

  • Must have a confirmed diagnosis of small-cell lung cancer (SCLC), which is a type of lung cancer.
  • Must have normal laboratory test results at the start.
  • Must be in a stable medical condition, meaning no recent serious health issues or surgeries in the last 4 weeks.
  • Must have recovered from previous cancer treatments, except for hair loss.
  • Previous radiation treatment is allowed if it was completed more than 2 weeks before starting the study and any side effects are mild.
  • Must be able to follow the study's requirements.
  • Must be able to provide written consent to participate in the study.
  • Must be 18 years of age or older.
  • Must have a life expectancy of at least 12 weeks.
  • The cancer must have worsened at least 60 days after finishing the first round of chemotherapy, which included at least 4 cycles of specific drugs.
  • No previous radiation treatment on the only area where the cancer has worsened, unless it showed further progression.
  • Must have an ECOG performance status of 2 or less, which is a measure of daily living abilities.
  • Patients with treated brain metastases (cancer spread to the brain) are eligible if they are not on steroids or on a stable low dose.
  • Females must be postmenopausal or surgically sterile, or if of childbearing potential, must have a negative pregnancy test and agree to use two methods of birth control.
  • Males must agree to use effective barrier contraception or practice abstinence during the study and for 6 months after the last dose of the study drug.

Who cannot join the trial?

5 criteria

  • Patients who do not have small cell lung cancer (SCLC) cannot participate. SCLC is a type of lung cancer that grows quickly.
  • Patients who have not received first-line chemo-immunotherapy for their SCLC cannot participate. Chemo-immunotherapy is a treatment that combines chemotherapy and immunotherapy to fight cancer.
  • Patients who are not experiencing progression of their SCLC after first-line chemo-immunotherapy cannot participate. Progression means that the cancer is getting worse or spreading.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, like children or people with certain disabilities.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. In this study, atezolizumab is being used in combination with chemotherapy to see if it can improve survival in patients with a type of lung cancer that has returned after initial treatment.

  • Platinum-Etoposide Chemotherapy

    is a standard treatment for certain types of lung cancer. It combines two chemotherapy drugs: a platinum-based drug and etoposide. These drugs work together to kill cancer cells or stop them from growing. In this trial, the chemotherapy is being used alongside atezolizumab to see if the combination is more effective than chemotherapy alone.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered intravenously and is currently being studied for its effectiveness in treating small cell lung cancer (SCLC) that has progressed after initial treatment. It is an approved medication in the field of oncology and is well-documented in medical literature. The main therapeutic indication for atezolizumab is to enhance the immune system's ability to fight cancer by targeting and inhibiting the PD-L1 protein, which can help prevent cancer cells from evading immune detection. It belongs to the pharmacological class of immune checkpoint inhibitors, specifically targeting the PD-L1 pathway to boost the body's immune response against cancer cells.

Investigated diseases

Small Cell Lung Cancer (SCLC) – Small Cell Lung Cancer 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, often spreading to other parts of the body. SCLC is typically associated with smoking and is more aggressive than other types of lung cancer. The disease often presents with symptoms such as coughing, chest pain, and difficulty breathing. Due to its rapid progression, SCLC is usually diagnosed at an advanced stage. The disease is divided into two stages: limited stage, where cancer is confined to one lung and nearby lymph nodes, and extensive stage, where it has spread beyond that.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511945-20-00Protocol codeGOIRC-01-2023Estimated enrolment142 patientsSponsorGOIRC Gruppo Oncologico Italiano Di Ricerca Clinica

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.