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 study about?

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.

1 initiation of treatment

The treatment begins with the administration of three medications: atezolizumab, paclitaxel, and carboplatin. These medications are given through a vein, a method known as intravenous use.

The specific dosages are as follows: atezolizumab is provided as a 1,200 mg concentrate for solution for infusion, paclitaxel is given as a 6 mg/ml concentrate for solution for infusion, and carboplatin is administered as a 10 mg/ml concentrate for solution for infusion.

2 chemotherapy phase

During this phase, the combination of atezolizumab, paclitaxel, and carboplatin is used to treat non-small cell lung cancer (NSCLC) at stages IIIA and IIIB.

The goal is to evaluate the progression-free survival rate at 18 months, which means assessing the time from the start of treatment until the disease progresses or the patient passes away.

3 surgery and adjuvant treatment

For patients who are candidates for surgery, the next step involves surgical intervention followed by adjuvant treatment with atezolizumab.

Adjuvant treatment is additional therapy given after the primary treatment to lower the risk of the cancer returning.

4 maintenance treatment for non-resected patients

Patients who are not candidates for surgery will receive maintenance treatment with atezolizumab after completing chemoradiotherapy.

This phase aims to maintain the benefits achieved during the initial treatment phase and to prevent the cancer from progressing.

5 follow-up and evaluation

Throughout the trial, regular follow-up visits are scheduled to monitor the patient’s health and the effectiveness of the treatment.

The primary focus is on evaluating the progression-free survival rate at 18 months, as well as other outcomes such as overall survival and response to treatment.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario Basurto	Bilbao	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Son Llatzer	Palma	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Salut Sant Joan De Reus	Reus	Spain
Pjft Tzwmy Hzfhsubv Uiiedgzovhst	Sabadell	Spain
Hfqbdyrd Di Ly Svlls Crmd I Svrd Pfs	Barcelona	Spain
Imocimwd Cnklcn Dnjsyyddnjagcxjgk	L'hospitalet De Llobregat	Spain
Hkhkdrhw Vzzq djrdckmf	Barcelona	Spain
Hulzbkmm Uzfcvhakggacg de A Chwocn	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.05.2025

Trial locations

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.

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 ID:

2024-515984-68-00

Protocol code:

GECP 23/02

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Atezolizumab, Paclitaxel, and Carboplatin for Patients with Stage IIIA and IIIB Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?