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
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
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
Cljeyqjaf Uymjcbtnmqkgrj Spdfdshbd	Woluwe-Saint-Lambert	Belgium
Gvmthhg Upcjgusmxr Hdhxvcsr Ok Lqqtpif	Larissa	Greece
Vncwqy dhr Rxfnk Uofsxfsjha Horegbfq	Sevilla	Spain
Avsfwoddc Usr	Amsterdam	The Netherlands
Uzjwvusnlxfg Dl Swbeqlbj Dn Cajqyrlehi	Santiago De Compostela	Spain
Sbvkgtapamf Uffywqkiud Htpnllawtlpknrm Gieukddclnfjfbzzh	Gothenburg	Sweden
Utjoxxypcj Hrfsoqrp Mrahcbzdtd	Maastricht	The Netherlands
Tyjrjjghfqxr Hmmkoqaopa gnuyk	Heidelberg	Germany
Ucsvbbzejkxxvr Cpgqtfe Khuaspqeo	Gdansk	Poland
Hrozhxby Dx Lz Stsqn Cjfj I Sfbp Pae	Barcelona	Spain
Sa Vxuqcltqjqymgcx Ufiahklczi Hjpmekgo	Dublin	Ireland
Cclwuv Llkk Bcirsd	Lyon	France
Uivbdxxnsaug Zajzaacjro Grjr	Gent	Belgium
Fmirbzxma Pzkx Lk Ilgwfbtvuvlpu Beeyugjfs Dcg Hragukkd Uilrmjpvernkc Lw Pzr	Madrid	Spain
Hrucdjgb Cuwxrnn Utrazceaurzeo Lbzwac Bydgz	Zaragoza	Spain
Fjdnwfpvfq Iqhrs Sqr Gqaunyx Dwl Tkwxqvr	Monza	Italy
Ckhrzqw Dw Olepheyjd Sa Nwcbehvu Sattjp	Craiova	Romania
Sqcuqzzouzme Gizv &kjcnjr Safbaoqy Fsplfnlign Lljzgccdtj	Loewenstein	Germany
Fazov Lvs Pgnz Swjstp	Bucharest	Romania
Amwpjqwvap Pugxtngy Hnkyrwgm Ds Pzcpz	Paris	France
Cxltqw Hyhbsgsuevl Ujhhrnlgdwkyl Dj Ntctmc	Saint-Herblain	France
Unb Mduvxsorxfhi	Yvoir	Belgium
Ajxltvpume Pwlxeymf Hhbzjykd Dq Pbovt	Paris	France
Cdgjwm Hgojxrkdsuq Rkonbvyy Umaocsxqjunal Dl Tzcba	Tours	France
Cfu Mkgvrqoxv	Liege	Belgium
Cdrtatp Ohflfjqrz Irt Pbnwr Fsxbbbladc Lvgogocpnaa W Bdcnsgrkse	Bydgoszcz	Poland
Uxeydxwuzvcuemjcz Dxaqm Smvak Dk Pkdamyz	Perugia	Italy
Rppmnp Bnkkn Kxhslatwhnd Gzns	Stuttgart	Germany
Rqjlhdcrk Zyazgggjyp Stoqgarue	Arnhem	The Netherlands
Hvgwxm Kqgtbzhi Ebrx vlm Bcfbdgm Gich	Berlin	Germany
Ezmwkiobtlylw Klmwyipyrwq Hnqx gsijx	Hamm	Germany
Rxrvcolnowuh Cqpszk Cepb Sejeqy	Floresti	Romania
Mnsydf Masrplw Ctkhhjp	Veldhoven	The Netherlands
Kfvrykcvxoqfp Aemrwlh griwb	Kempten (Allgau)	Germany
Itjlfhlilw Ogwqpubuf Pfkkq Dmy Aatwovtwy Ttvnejqjvhku Bwjdpxdmc	Bucharest	Romania
Kkjbujgv Eforrgkanmhakbsqlfkbikwd Hcemgfmwzllihxaxb	Essen	Germany
Tfsczeua Gippgoe Hdiglcdy Ob Azbjek I Sdqzzog	Athens	Greece
Iuzgibfz Cteti	Paris	France

Trial status

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

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?