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Study of Nivolumab and Ipilimumab for Patients with Stage 3 Non-Small Cell Lung Cancer Not Suitable for Surgery

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What is this study about?

This clinical trial is focused on studying treatments for non-small cell lung cancer (NSCLC), specifically in cases where the cancer is locally advanced and has not been treated before. The study involves several medications, including nivolumab, ipilimumab, and durvalumab. These medications are used in combination with a treatment method called chemoradiotherapy, which combines chemotherapy and radiation therapy. The purpose of the study is to compare the effectiveness of different treatment combinations in improving the time patients live without the cancer getting worse.

Participants in the study will be randomly assigned to one of three groups. One group will receive nivolumab with chemoradiotherapy followed by nivolumab and ipilimumab. Another group will receive nivolumab with chemoradiotherapy followed by more nivolumab. The third group will receive chemoradiotherapy followed by durvalumab. The study will monitor how long patients live without the cancer progressing, as well as overall survival and response to the treatment.

The trial is designed to last several years, with regular check-ups and assessments to track the progress of the disease and the effects of the treatments. The study aims to provide valuable information on the best treatment options for patients with this type of lung cancer, potentially leading to improved outcomes and quality of life for those affected by the disease.

1 joining the study

Upon joining the study, you will be assigned to one of the treatment groups. This assignment is random, meaning it is done by chance, like flipping a coin.

You will be informed about the specific treatment plan you will follow, including the medications and procedures involved.

2 treatment initiation

The treatment will begin with a combination of medications and possibly radiation therapy, depending on your assigned group.

Medications such as nivolumab, ipilimumab, durvalumab, carboplatin, cisplatin, etoposide, paclitaxel, and pemetrexed may be used. These are given through an intravenous (IV) line, which means they are delivered directly into your bloodstream.

3 medication schedule

The frequency and duration of medication administration will vary based on the specific treatment group you are in.

You will receive detailed instructions on how often you will need to visit the clinic for your treatments and any additional procedures.

4 monitoring and assessments

Throughout the trial, regular monitoring will be conducted to assess your health and the effectiveness of the treatment.

This will include physical exams, blood tests, and imaging tests such as CT scans to track the progress of the treatment.

5 follow-up visits

After completing the treatment phase, follow-up visits will be scheduled to continue monitoring your health.

These visits are important to ensure any long-term effects of the treatment are managed appropriately.

6 end of trial

The trial is expected to conclude by December 2026, but your participation may end earlier depending on your treatment plan and health status.

You will be informed about the results of the trial and any further steps that may be necessary for your care.

Who Can Join the Study?

  • Must have previously untreated locally advanced non-small cell lung cancer (LA NSCLC).
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how a patient’s disease is progressing, including their level of functioning and ability to care for themselves.
  • Cancer must be at a locally advanced stage IIIA, IIIB, or IIIC. This means the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body.
  • Must be newly diagnosed and have not received any prior local or systemic anticancer therapy for the locally advanced disease. This means no previous treatments like chemotherapy or radiation for this condition.
  • Open to both male and female participants.
  • Participants must be within the specified age range for the study.
  • Includes individuals from vulnerable populations, which may refer to groups who might need special consideration or protection in research settings.

Who Cannot Join the Study?

  • Patients who have already received treatment for their lung cancer cannot participate.
  • Patients with other types of cancer besides non-small cell lung cancer are not eligible.
  • Patients with serious heart problems are excluded.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, such as a severe cold or flu, are not allowed.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to medications are excluded.
  • Patients who are unable to follow the study procedures or attend regular check-ups are not eligible.
  • Patients with a history of drug or alcohol abuse may be excluded.
  • Patients with certain autoimmune diseases, where the immune system attacks the body, cannot join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Centr Georges Francois Leclerc Dijon France
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Lungenfachklinik Immenhausen Germany

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Provita Centrum Medyczne Sp. z o.o. Tomaszow Mazowiecki Poland
Assistance Publique Hopitaux De Paris Paris France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre De Cancerologue Du Grand Montpellier Montpellier France
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Cnkkjfqmx Ukyexzaluuhnfq Sehtokdtd Woluwe-Saint-Lambert Belgium
Gmqnixd Uvbjaayhpn Hapopstf Ow Lihzmcu Larissa Greece
Viuhak dbc Rcpxz Uijriyvokg Haubjmok Sevilla Spain
Auaocmobn Ugj Amsterdam The Netherlands
Ukbmoryfbrkf Dv Scvhxmlb Dd Cduwaddyts Santiago De Compostela Spain
Sqhwmekqkss Utrkrzmsct Hitubnrghgfwqkj Guvdjzafcpcahgeds Gothenburg Sweden
Uiaymfluly Hpiolqgt Mtrcidckfh Maastricht The Netherlands
Txccqyzhylli Hbwziewpee gqcev Heidelberg Germany
Uefwjnnsrrnkqf Clvdbjy Kmbcvxgdx Gdansk Poland
Heokuwxx Da Lk Syccg Cyfa I Susc Pzh Barcelona Spain
Sj Vhazqckycemtxlz Uahfypimmi Hgfaautb Dublin Ireland
Cmigeh Lseq Bjgsej Lyon France
Uhvvsaedsccz Zsohljmfra Gzue Gent Belgium
Frxmvrpml Pvhg Lf Iiuoauiequuqt Bmlbipzvg Dlk Hmafymrx Ukprggwzsexkq Lw Pgg Madrid Spain
Htfgidbn Cjzazmj Undelplsrjoaq Lrcnxj Bxlib Zaragoza Spain
Frlwqacoos Iotmp Syu Gqatirx Dyw Tmkkwpp Monza Italy
Cyzuqqs Dj Osykqkqfu Sq Nfxqowex Sebahk Craiova Romania
Slqwfacyrvzu Gztl &kpvpzh Slytkseh Fseqfhfkgr Lnumummxha Loewenstein Germany
Fkyay Lhz Piqc Sbegsp Bucharest Romania
Aerrurdfon Pylqqaha Hdkgrbav Dl Pkdbz Paris France
Cmytxu Htbwzvfbxbu Ushffpxameexl Dd Nlhjzt Saint-Herblain France
Uac Mowdhvihxbki Yvoir Belgium
Atbkercolp Pvzupriw Htwaeuvq Di Puvww Paris France
Cvhczm Hcwlovoykpc Reglorvw Uhkpxdmeqpuhd De Tguuf Tours France
Cyz Mgjkmqrev Liege Belgium
Coujtfq Odixbbygv Iou Pfbyv Frxxyjozuk Laubxgvxmgx W Bddjxaitvk Bydgoszcz Poland
Usiiwyexpuqeecvdh Dfleu Sznjp Da Pkapqet Perugia Italy
Rdzdcm Bvvis Kwzurqaahkv Gsjk Stuttgart Germany
Reavnfpku Zmdgbnsylx Sdhvxzbzk Arnhem The Netherlands
Hlyrqs Ksucowfi Eqbd vpg Bwdlbfp Gajw Berlin Germany
Emshditbywmlj Kvjreasikwn Hcwj gzdgl Hamm Germany
Rymvuommpktp Cisphu Cpgh Sfuojt Floresti Romania
Mkmhfp Mnvjrjy Cmjhzpw Veldhoven The Netherlands
Kbhvavebuajjw Akpovpb gnydc Kempten (Allgau) Germany
Icnwlfeykr Oonjpbass Pcmrg Dra Apzffgjfs Thazsofxtlyk Brsubacdw Bucharest Romania
Kioqmzdg Egtuhxkvpeuoryklmetjwrgt Hogeprzfnpuirezey Essen Germany
Tpiezqkr Gkdfwgv Hkmbfwff Ot Ackowd I Svkttdq Athens Greece
Iwtiplsn Cpcwn Paris France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
20.08.2019
France France
Not recruiting
20.08.2019
Germany Germany
Not recruiting
20.08.2019
Greece Greece
Not recruiting
20.08.2019
Ireland Ireland
Not recruiting
20.08.2019
Italy Italy
Not recruiting
20.08.2019
Poland Poland
Not recruiting
20.08.2019
Romania Romania
Not recruiting
20.08.2019
Spain Spain
Not recruiting
20.08.2019
Sweden Sweden
Not recruiting
20.08.2019
The Netherlands The Netherlands
Not recruiting
20.08.2019

Trial locations

Investigated Drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used in combination with other treatments to help treat locally advanced non-small cell lung cancer.

Ipilimumab is another immune checkpoint inhibitor. It helps boost the immune system’s response against cancer cells. In this study, it is used alongside Nivolumab to enhance the body’s ability to fight lung cancer.

Durvalumab is also an immune checkpoint inhibitor. It helps the immune system detect and destroy cancer cells. In this trial, it is used after chemoradiotherapy to help prevent the cancer from progressing.

Investigated Diseases:

Non-small Cell Lung Cancer (NSCLC) – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow and form tumors, which can invade nearby tissues and organs. As it advances, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. The progression can vary depending on the subtype and stage at diagnosis. Over time, it may lead to complications such as pleural effusion or metastasis to distant organs.

Trial ID:
2022-502886-71-00
Protocol code:
CA209-73L
NCT ID:
NCT04026412
Trial Phase:
Therapeutic confirmatory (Phase III)

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