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Study of Lurbinectedin and Atezolizumab in Patients with Advanced Small Cell Lung Cancer Who Have Previously Received Platinum Chemotherapy

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What is this study about?

This study focuses on patients with Small Cell Lung Cancer that has advanced after previous treatment with platinum-based chemotherapy. The research evaluates a combination of two medications: lurbinectedin (also known as PM01183) and atezolizumab (Tecentriq). Both medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this research is to determine if this combination of medications is safe and effective for treating advanced Small Cell Lung Cancer. The study is divided into two parts. The first part aims to find the right dose of the medications that can be safely given together. The second part evaluates how well the treatment works in fighting the cancer.

During the study, participants receive regular infusions of both medications. Their cancer is monitored through regular imaging tests every six weeks to check how the treatment is working. The study team tracks any side effects and how well patients respond to the treatment. Some patients may also provide blood and tissue samples to help researchers better understand how the medications work in the body.

1 Initial treatment preparation

Before starting treatment, your doctor will perform tests to check your bone marrow, kidney, liver, and metabolic function. These tests must be completed within 7 days before starting the study.

Your doctor will evaluate if you have measurable tumors that can be monitored during the treatment.

2 Treatment administration

You will receive two medications through an intravenous infusion: lurbinectedin (also known as PM01183) and atezolizumab (Tecentriq).

The treatment will be given in cycles. Each infusion session will take place at the hospital.

3 Regular monitoring

Every 6 weeks (with a 2-week flexibility), you will have imaging tests to check how your tumors are responding to treatment.

If the treatment appears to be working, additional scans will be performed at least 4 weeks later to confirm the positive response.

Blood samples will be collected on the first day of each treatment cycle.

Your doctor will monitor any side effects using standardized criteria to grade their severity.

4 Ongoing assessments

Treatment will continue until either your disease shows progression or you start a new cancer therapy.

If your doctor notices potential benefits despite initial signs of tumor growth, they may continue the treatment and monitoring.

Regular blood tests will continue throughout your treatment to ensure your safety.

5 Post-treatment period

After completing treatment, you must continue using effective contraception for at least 5 months following your last dose of atezolizumab.

Women must continue contraception for 6 weeks and men for 4 months after the last dose of lurbinectedin.

Who Can Join the Study?

  • Must sign a voluntary informed consent document before starting any study procedures
  • Must be over 18 years old
  • Must have a confirmed diagnosis of small cell lung cancer through tissue or cell examination
  • Must have experienced disease progression after receiving platinum-based chemotherapy. There must be at least 30 days between the last chemotherapy dose and disease progression
  • Must have a performance status score of 0 or 1 (able to perform daily activities with minimal limitations)
  • Must have measurable disease that can be evaluated using specific criteria (called RECIST)
  • Must wait at least three weeks after any previous cancer treatment and recover from most side effects
  • Must have adequate:
    • Blood cell counts
    • Kidney function
    • Liver function
    • Metabolic function
  • For women who can become pregnant and men with partners who can become pregnant:
    • Must use effective birth control during the study
    • Women must continue birth control for 5 months after treatment
    • Men must continue birth control for 4 months after treatment
    • Men must not donate sperm during this period

Who Cannot Join the Study?

  • Prior treatment with atezolizumab (a type of immunotherapy medication)
  • History of autoimmune disease requiring systemic treatment in the past 2 years
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart problems in the past 6 months
  • Active or chronic liver disease
  • Known HIV infection or active hepatitis B or C
  • Other active cancers requiring treatment
  • Previous severe allergic reactions to similar medications
  • Pregnancy or breastfeeding
  • Inability to swallow oral medications
  • Major surgery within 4 weeks before starting the study
  • Any serious medical condition that could interfere with study participation
  • Current participation in other clinical trials
  • Use of live vaccines within 4 weeks before starting the study
  • Ongoing side effects from previous cancer treatments

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
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Htydyrtn Du Lp Swjvb Cdzy I Shxw Psk Barcelona Spain
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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
Spain Spain
Not recruiting
02.09.2019

Trial locations

Investigated drugs:

PM01183 (Lurbinectedin)
A medication used to treat small cell lung cancer. It works by blocking certain proteins that cancer cells need to grow and spread. It is typically used when cancer has progressed after initial chemotherapy treatment.

Atezolizumab
An immunotherapy medication that helps the body’s immune system fight cancer cells. It works by blocking a protein called PD-L1, which can help the immune system recognize and attack cancer cells. It is commonly used in the treatment of various types of cancer, including small cell lung cancer.

Investigated diseases:

Small Cell Lung Cancer (SCLC) – A fast-growing type of lung cancer that develops from neuroendocrine cells in the lungs. It typically starts in the airways of the lungs and can spread quickly to other parts of the body. The disease is characterized by small, round cells that cluster together. SCLC can be classified into two stages: limited stage, where cancer is confined to one side of the chest, and extensive stage, where cancer has spread beyond one side of the chest. The condition can affect breathing and may cause symptoms such as persistent cough, chest pain, and shortness of breath. The disease commonly occurs in people with a history of smoking.

Trial ID:
2024-517705-93-00
Protocol code:
2SMALL
Trial Phase:
Human Pharmacology (Phase I) – Other

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