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Study of Atezolizumab and Chemotherapy for Patients with Relapsed 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 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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Santa Maria Della Misericordia Perugia Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Unita Sanitaria Locale Di Modena Carpi Italy
Asst Di Mantova Mantova Italy
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Degli Studi Di Verona Verona Italy
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Icdtorbv Rynutvnpq Pqx Lw Sbbvni Dnr Txahtn Dpbr Apfxnug Ixcu Sxnklw Meldola Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
03.09.2024

Trial locations

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.

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 ID:
2024-511945-20-00
Protocol code:
GOIRC-01-2023
Trial Phase:
Therapeutic exploratory (Phase II)

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