Study on Atezolizumab with Chemoradiotherapy for Patients with Limited Disease 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 limited disease small-cell lung cancer (LD SCLC). The trial is investigating a treatment called atezolizumab, which is also known by its code name RO5541267. Atezolizumab is a medication given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to see if atezolizumab can help improve the survival of patients who have already completed a combination of chemotherapy and radiation therapy, known as chemoradiotherapy.

Participants in the study will be randomly assigned to one of two groups. One group will receive atezolizumab after completing chemoradiotherapy, while the other group will continue with chemoradiotherapy alone. The study will monitor participants over a period of time to assess their overall survival, which refers to the length of time patients live after starting the treatment. Other aspects being observed include the best response to the treatment, how long patients live without the cancer getting worse (progression-free survival), any side effects (toxicity), and the impact on the patients’ quality of life.

The trial aims to provide valuable information on whether adding atezolizumab to the standard treatment can offer better outcomes for patients with limited disease small-cell lung cancer. This study is part of ongoing research to find more effective treatments for this type of cancer and to improve the lives of those affected by it.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after being informed about the study’s details and potential risks.

You must be at least 18 years old and have a confirmed diagnosis of limited disease small-cell lung cancer.

2 initial assessment

An initial assessment will be conducted to ensure you meet all eligibility criteria. This includes checking your kidney, liver, and bone marrow function, as well as your pulmonary function.

Your disease must be measurable according to specific criteria if you are enrolled before starting chemoradiotherapy.

3 treatment phase

You will undergo concurrent chemoradiotherapy, which is a combination of chemotherapy and radiation therapy.

After completing chemoradiotherapy, you may receive the medication atezolizumab (Tecentriq 1 200 mg) through an intravenous infusion. This means the medication is given directly into your vein.

4 medication administration

The medication atezolizumab will be administered as a solution for infusion. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

5 follow-up and monitoring

Throughout the study, your health and response to treatment will be closely monitored. This includes regular check-ups and assessments to evaluate your overall survival and any side effects.

Your quality of life and any potential toxicity from the treatment will also be assessed.

6 end of study

The study is estimated to end by December 31, 2042. Your participation may continue until the study’s conclusion or until your healthcare provider advises otherwise.

Who Can Join the Study?

Must be 18 years or older.
Must provide written informed consent, which means you agree to participate after being fully informed about the study.
Must have a diagnosis of small-cell lung cancer confirmed by a doctor through tests.
Cancer must be in Stage I-III and not suitable for surgery, but all cancer areas can be treated with radiation.
Must have an ECOG performance status of 0-2, which is a scale that measures your ability to perform daily activities. A score of 0 means fully active, and 2 means you are up and about more than half the day.
Must have measurable disease according to specific criteria if joining the study before starting chemoradiotherapy.
Must have adequate kidney, liver, and bone marrow function, meaning these organs are working well enough.
Must have adequate lung function, with specific measures: FEV1 (a lung function test) greater than 1 liter or more than 30% of the expected value, and DLCO (another lung function test) more than 30% of the expected value. If lung function is reduced due to tumor blockage, you may still be eligible if a radiotherapist approves you for chest radiation.

Who Cannot Join the Study?

Patients who have not completed chemoradiotherapy. Chemoradiotherapy is a combination of chemotherapy and radiation therapy used to treat cancer.
Patients with medical conditions other than limited disease small-cell lung cancer. Limited disease small-cell lung cancer is a type of lung cancer that is confined to one side of the chest.
Patients who are part of a vulnerable population. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Isala Klinieken Stichting	Zwolle	The Netherlands
Amphia Hospital	Breda	The Netherlands
St. Olavs Hospital HF	Trondheim	Norway
Lund University Hospital	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Sørlandet sykehus Kristiansand	Kristiansand	Norway
Odense University Hospital	Odense	Denmark
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Gaevleborg	Gavle	Sweden
Rtswhkbfi Zdywixsaer Sxgmnswgm	Arnhem	The Netherlands
Hrbre Nhvducrwawomtd Hz	Levanger	Norway
Ahkkgoet Uwzeggscru Hsvxxajt	Lorenskog	Norway
Hogqf Bphmrc Hk	Bergen	Norway
Ezixnzl Usvnwjnvgydv Mjhgfys Cycoccm Rmpvttkde (inrdeze Mhn	Rotterdam	The Netherlands
Hkehd Mvwud Of Rajyxde Hk	Aalesund	Norway
Vtaiwffgk itifalyw Vdzkohof umgeyvvgrkak lvushnaqe Sxfszske kjhwuvb fjibvyzd Nflgnxeuwxyo vllii ccosgyg	Vilnius	Lithuania

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	31.07.2018
Lithuania	Not recruiting	31.07.2018
Norway	Not recruiting	31.07.2018
Sweden	Not recruiting	31.07.2018
The Netherlands	Not recruiting	31.07.2018

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells more effectively. In this trial, atezolizumab is being tested to see if it can improve the survival of patients with a specific type of lung cancer called limited disease small-cell lung cancer. After patients have completed their initial treatment with chemotherapy and radiation, atezolizumab is given to see if it can help keep the cancer from coming back or growing.

Investigated diseases:

Small cell lung cancer

Limited disease small-cell lung cancer – This form of lung cancer is characterized by the presence of cancerous cells that originate in the lung tissue and are confined to one side of the chest. It is a subtype of small-cell lung cancer, which is known for its rapid growth and tendency to spread quickly. In limited disease, the cancer is typically restricted to the lung and nearby lymph nodes. The progression involves the potential for the cancer to grow and invade nearby structures, but it has not yet spread to distant parts of the body. As the disease advances, symptoms may include coughing, chest pain, and difficulty breathing. The disease is often aggressive, requiring prompt medical attention to manage its progression.

Trial ID:

2024-515755-37-00

Protocol code:

ACHILES

NCT ID:

NCT03540420

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atezolizumab with Chemoradiotherapy for Patients with Limited Disease Small-Cell Lung Cancer

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