Study on Atezolizumab with Platinum-Based Chemotherapy for Patients with Early-Stage Resectable Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer that can be surgically removed. The study involves the use of a medication called atezolizumab, which is an immunotherapy drug that helps the immune system fight cancer. Atezolizumab will be used in combination with platinum-based chemotherapy, which includes drugs like cisplatin and carboplatin. These chemotherapy drugs contain platinum and are used to kill cancer cells. The study also involves a placebo, which is a substance with no active medication, to compare the effects of atezolizumab.

The purpose of the study is to evaluate how effective and safe the treatment is when given before surgery (neoadjuvant treatment) and followed by additional atezolizumab after surgery (adjuvant treatment). Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, during which participants will receive the treatment and be monitored for any changes in their condition.

Throughout the study, the main focus will be on how long participants remain free from cancer events, which is known as event-free survival. The study will also look at other outcomes, such as the overall survival of participants and any side effects they may experience. The goal is to determine if the combination of atezolizumab and platinum-based chemotherapy is more effective than chemotherapy alone in treating early-stage resectable NSCLC.

1 initial treatment phase

The initial phase involves receiving a combination of medications through an intravenous infusion. This includes atezolizumab or a placebo, along with platinum-based chemotherapy drugs such as cisplatin or carboplatin, and other drugs like pemetrexed or gemcitabine.

The medications are administered in cycles, with each cycle lasting approximately three weeks. The exact number of cycles will depend on the specific treatment plan.

2 surgical intervention

After completing the initial treatment phase, a surgical procedure is planned to remove the lung cancer. The surgery aims to achieve a complete removal of the tumor with curative intent.

Eligibility for surgery is determined based on adequate pulmonary, cardiac, hematologic, and end-organ function.

3 adjuvant treatment phase

Following surgery, an additional treatment phase with atezolizumab is conducted. This phase is designed to help prevent the cancer from returning.

The adjuvant treatment is administered through intravenous infusion at specified intervals, continuing for a duration determined by the treatment plan.

4 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor recovery and assess the effectiveness of the treatment.

These appointments may include imaging tests, blood tests, and assessments of health-related quality of life.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must be able to receive a platinum-based chemotherapy treatment. This is a type of cancer treatment that uses drugs containing the metal platinum.
  • Must have a confirmed diagnosis of Stage II, IIIA, or certain IIIB (T3N2 only) non-small cell lung cancer (NSCLC). This means the cancer is in an early stage where it can be surgically removed. The cancer can be of two types: squamous or non-squamous.
  • The cancer must appear as a solid or subsolid mass on a CT scan, which is a detailed imaging test. It should not appear as a purely ground-glass opacity (GGO), which is a hazy area seen on the scan.
  • Must be eligible for R0 resection, which means surgery can be done with the goal of completely removing the cancer.
  • Must have adequate lung, heart, blood, and organ function to safely undergo surgery aimed at curing the cancer. This is determined by tests that check how well the lungs are working, known as Pulmonary function tests (PFTs).

Who Cannot Join the Study?

  • Patients with other types of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
  • Patients who have already received treatment for their lung cancer are not eligible.
  • Patients with serious heart problems cannot join the study.
  • Patients with active infections, such as HIV or hepatitis, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with autoimmune diseases, where the immune system attacks the body, are not eligible.
  • Patients who have had an organ transplant cannot join the study.
  • Patients taking certain medications that affect the immune system are excluded.
  • Patients with a history of severe allergic reactions to the study drugs cannot participate.
  • Patients with any other medical condition that the study doctors think would make it unsafe to participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Son Llatzer Palma Spain
Centre Hospitalier De Saint-Quentin Saint Quentin France
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Hbtijawr Vmts dlqoxnjs Barcelona Spain
Rwdjkk Sbkmr Skqkal Ukqlbvxfdnrbqwhggcd Lund Sweden
Umklzwx Uujyniwolj Hhbjrtrk Uppsala Sweden
Hngjdhig Cldaivg Swx Cckdlx Madrid Spain
Jklphiih Kstojs Ushglsmkbm Linz Austria
Mpjaaai Chqzpu &ceficl Utzucdjyks Oo Fqtzccuq Freiburg Im Breisgau Germany
Umtaandjfystxr Cstjwkf Kpianenbb Gdansk Poland
Ckbjxa Liex Bndzkc Lyon France
Ogpujrcaveqwhc Lopn Gvkv Linz Austria
Aavqdrxet Kbrsez Gkjulpz Gazr Gauting Germany
Caqjxs Hnuzjomhwtt Rwglmxtl Dhsscwcsidakqf Angers France
Ktzedizvzow Nbho Kckhxf Fsvftddreuy Vienna Austria
Sndeq Wmuo Wydahc Gquyexpnybwuqrqomk Vienna Austria
Fznoqdkmjk Ikijftqcej Izrznbbl Nrfymcowjcf Bcevu Milan Italy
Hozozflr Uufeogwgjcbbeg Sdgetzvwof &qiblix Htaehsg do Hjurkidflby STRASBOURG, Alsace France
Ibeoqfnj Ogrfgjtnrv Vujifv Padua Italy
Phpq Trzck Huxtlvnh Ulugculmaewc Sabadell Spain
Pzkrzwtyiblbd Owjpzjuya Oldenburg In Holstein Germany
Hfb Szpshg Ajsq Toulon France
Uvagbbkbca Cwlojj Gvyigr Golnik Slovenia
Ujetnajoxvbbtpwknzyak Rqwsskelxc Ato Regensburg Germany
Uvwqekhtpwnwpxicy Clghee Bsnlwpefeb Dw Rnob Rome Italy
Uxgakbrhzgbwxblmi Dt Pipo Pisa Italy
Nnkzrndr Igseujqd Oexlzgfuj Iyq Mxlgc Snojxrlzezidmqfyfzodlbpxetjh Ifvarkfl Bytshtdh Cracow Poland
Uxhcq Do Rakehicjv Cdehssrb Hds Bxknm Saint-Mande France
Kjhcddoy Wrxxzxebc Msabl guptr Wuerzburg Germany
Rynmxj Ozbgbgqaokmajr Linkoping Sweden
Ryjmsv Bsrbv Gxpkgbhdrofk fqzz mxfsyajsmqiw Fqxpgicji moj Stuttgart Germany
Hurhxqtk Ufexhwgtqdtin Bptkumw Bilbao Spain
Mgezcpfnhntt Kkzirlcntqi Hzasdxbcydtw galof Halle (Saale) Germany
Kllndjpyp Sulrrgl Sgzagfwkjpcdpmp ik Jpyz Pkvbu Ik Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
17.05.2018
France France
Not recruiting
17.05.2018
Germany Germany
Not recruiting
17.05.2018
Italy Italy
Not recruiting
17.05.2018
Poland Poland
Not recruiting
17.05.2018
Slovenia Slovenia
Not recruiting
17.05.2018
Spain Spain
Not recruiting
17.05.2018
Sweden Sweden
Not recruiting
17.05.2018

Trial locations

Atezolizumab is a medication used in this trial to help the body’s immune system fight cancer. It is given to patients before surgery to shrink the tumor and after surgery to help prevent the cancer from coming back. It works by blocking a protein that stops the immune system from attacking cancer cells.

Platinum-Based Chemotherapy refers to a group of chemotherapy drugs that contain the metal platinum. These drugs are used to kill cancer cells or stop them from growing. In this trial, they are combined with atezolizumab to treat lung cancer before surgery.

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 cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may occur. The disease can spread to other parts of the body, including the bones, brain, and liver. Early-stage resectable NSCLC refers to tumors that can be surgically removed, offering a potential for cure if detected early.

Trial ID:
2023-504209-35-00
Protocol code:
GO40241
NCT ID:
NCT03456063
Trial Phase:
Therapeutic confirmatory (Phase III)

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