El Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria, Spain
Recruiting
Study of Atezolizumab, Paclitaxel, and Carboplatin for Patients with Stage IIIA and IIIB Non-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 non-small cell lung cancer (NSCLC), specifically in stages IIIA and IIIB. The study involves a combination of treatments, including chemotherapy and a medication called atezolizumab, which is also known by its code name RO5541267. Chemotherapy drugs used in this study include paclitaxel and carboplatin. Atezolizumab is given as a solution through a vein, a method known as intravenous infusion.
The purpose of the study is to evaluate how well these treatments work in preventing the cancer from getting worse over time. Participants will receive chemotherapy combined with atezolizumab, followed by atezolizumab alone as a continued treatment. For those who undergo surgery, atezolizumab will be given afterward to help prevent the cancer from returning. For patients who do not have surgery, atezolizumab will be used after they receive a combination of chemotherapy and radiation therapy.
The study will monitor participants over a period to see how long they remain free from cancer progression, which means the cancer does not grow or spread. The trial will also look at other outcomes, such as the rate of successful surgeries and overall survival rates. This research aims to provide more information on the effectiveness of combining these treatments for patients with advanced stages of NSCLC.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
14 criteria
- Patients must have **non-small cell lung cancer (NSCLC)** that has not been treated before and is at stage IIIA to IIIB.
- A **PET-CT** and brain **CT** or **MRI** scan must show no spread of the disease to distant parts of the body.
- Patients should have an **ECOG performance status** of 0-1, which means they are fully active or have some symptoms but do not need bed rest.
- Patients must have good blood and organ function based on lab tests done within 14 days before joining the study.
- Patients must be informed about the study's experimental nature and sign a written consent form before any study-related procedures.
- Patients must have good lung function, with a **Forced Expiratory Volume in 1 second (FEV1)** greater than 50% of normal and a **Diffusion Capacity of the Lungs for Carbon Monoxide (DLCO)** greater than 40% of normal.
- Patients must be older than 18 years.
- Female patients who can have children must agree to use a highly effective form of birth control with a low failure rate and continue using it for 6 months after the last dose of the study treatment.
- Male patients with female partners who can have children must agree to use a highly effective form of birth control with a low failure rate and continue using it for 6 months after the last dose of the study treatment. They should not donate sperm during the study and for at least 6 months after the last dose.
- Oral contraception should be combined with another method of birth control due to possible interactions with the study drugs. This applies to both male and female patients.
- Women who are not postmenopausal or surgically sterile must have a negative pregnancy test within 8 days before starting the study drug.
- Patients must be able to follow the treatment plan correctly and be available for follow-up visits.
- There must be at least one measurable tumor lesion as seen on a **CT-SCAN**, according to specific guidelines.
- Patients should have a life expectancy of at least 12 weeks.
Who cannot join the trial?
9 criteria
- Patients with any other type of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
- Patients who have a medical condition that might interfere with the study or make it unsafe for them to participate.
- Patients who are currently pregnant or breastfeeding.
- Patients who have participated in another clinical trial within the last 30 days.
- Patients who have a history of severe allergic reactions to any of the study medications.
- Patients who have a serious infection or illness that requires treatment with antibiotics or other medications.
- Patients who have a history of drug or alcohol abuse that might interfere with their ability to follow the study procedures.
- Patients who have a mental health condition that might affect their ability to understand or follow the study instructions.
- Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Verified Hospital De La Santa Creu I Sant Pau
Barcelona, SpainVerified Hospital General Universitario De Valencia
Valencia, Spain
Trial locations
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Investigated drugs
Atezolizumab is a medication used in this clinical trial to help treat non-small cell lung cancer. It is an immunotherapy drug that works by helping the body's immune system recognize and attack cancer cells more effectively. In this trial, atezolizumab is used both after surgery as an adjuvant treatment and for patients who cannot have surgery, following chemoradiotherapy.
What is already known about the treatment
Atezolizumab – Atezolizumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC), particularly in stages IIIA and IIIB. The main therapeutic indication for atezolizumab is to help the immune system target and destroy cancer cells. It works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.
Investigated diseases
Non-small cell lung cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515984-68-00Protocol codeGECP 23/02Estimated enrolment97 patientsSponsorFundacion GECP
sourced from the EU Clinical Trials Register and site verification
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