Study Comparing Chemotherapy with Nivolumab to Chemotherapy Alone for Patients with Resectable Non-small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for non-small cell lung cancer that can be completely removed by surgery. The study involves comparing two different treatment approaches. One group of participants will receive a combination of chemotherapy and a medication called nivolumab, which is also known by its code name BMS936558. The other group will receive chemotherapy along with a placebo. After surgery, participants will continue to receive either nivolumab or a placebo.

The purpose of this study is to evaluate the effectiveness of these treatments in improving the time participants remain free from cancer-related events. Participants will undergo a series of treatments and follow-ups over a period of time. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving nivolumab or the placebo during the trial. This helps ensure the results are unbiased and reliable.

Throughout the study, participants will receive their treatments through intravenous infusions, which means the medication is given directly into a vein. The study aims to provide valuable information on whether adding nivolumab to chemotherapy before and after surgery can improve outcomes for patients with resectable non-small cell lung cancer. The trial will also monitor the safety and any side effects of the treatments to ensure the well-being of the participants.

1 joining the study

Upon joining the study, participants will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the experimental treatment or the standard treatment.

2 neoadjuvant treatment

Participants will receive neoadjuvant chemotherapy, which is treatment given before surgery. This involves receiving medications through an intravenous (IV) line, which means the medication is delivered directly into a vein.

The medications used in this phase may include carboplatin, paclitaxel, cisplatin, docetaxel, and pemetrexed. The specific combination and dosage will depend on the group assignment.

In addition to chemotherapy, some participants will receive nivolumab, an immunotherapy drug, while others will receive a placebo, which is a substance with no active medication. This phase lasts for a specified period, typically several weeks, depending on the treatment plan.

3 surgical resection

After completing the neoadjuvant treatment, participants will undergo surgery to remove the lung cancer. This is known as surgical resection. The goal is to remove all visible cancer from the lung.

4 adjuvant treatment

Following surgery, participants will receive adjuvant treatment, which is additional therapy to help prevent cancer from returning. This may include nivolumab or a placebo, depending on the group assignment.

The adjuvant treatment is administered through an IV line and continues for a specified duration, which will be communicated by the healthcare team.

5 follow-up and monitoring

Participants will have regular follow-up visits with the healthcare team to monitor their health and the effects of the treatment. This includes physical exams, imaging tests, and laboratory tests.

The follow-up period is designed to track the participant’s recovery and any potential side effects from the treatment.

Who Can Join the Study?

Participants must have a type of lung cancer called Stage IIA to IIIB non-small cell lung carcinoma (NSCLC) that can be surgically removed.
Participants must not have cancer that has spread to the brain (no brain metastasis).
Participants must not have received any previous treatment for NSCLC (treatment-naive).
Participants must be able to provide a sample of their tumor through surgery or a biopsy for testing (biomarkers).
Participants must have a performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest. This is measured by the Eastern Cooperative Oncology Group (ECOG).
Participants of all genders are eligible.

Who Cannot Join the Study?

Patients with any other type of cancer that is not resectable Stage II-IIIB Non-small cell lung cancer cannot participate. Resectable means that the cancer can be removed by surgery.
Patients who have had another cancer in the past, unless it was a type of skin cancer called basal cell carcinoma or squamous cell carcinoma, or a type of cervical cancer called cervical carcinoma in situ, which have been treated successfully.
Patients who have had a heart attack or severe heart problems in the last 6 months cannot participate.
Patients with uncontrolled high blood pressure cannot participate. Uncontrolled means that the blood pressure is not being managed well with medication or lifestyle changes.
Patients with an active infection that requires treatment with antibiotics cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with a known allergy to the study medication or its ingredients cannot participate.
Patients with a history of drug or alcohol abuse within the last 12 months cannot participate.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate cannot join the study.

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
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
CHC MontLegia	Liege	Belgium
Assistance Publique Hopitaux De Paris	Paris	France
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Franziskus Hospital Harderberg	Georgsmarienhütte	Germany
Centre Hospitalier Universitaire Rouen	Rouen	France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Evangelisches Krankenhaus Hamm gGmbH	Hamm	Germany
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
RKH Klinken Ludwigsburg-Bietigheim gGmbH	Ludwigsburg	Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Fakultni Thomayerova nemocnice	Prague	Czechia
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Klinikverbund Allgau gGmbH	Immenstadt im Allgäu	Germany
Itxzncdb Rwqruworp Pio Ly Ssnmtm Duk Tmxzan Dykh Aihomif Icdh Slbxsk	Meldola	Italy
Kzazko Llqvmrfsaev gzgpy	Loewenstein	Germany
Klnvtyefsnq Bmejqcqyt	Moers	Germany
Ermfbvx Uofeagvodrnf Mqqvuiw Cklznsp Rewwxdgre (wyeutph Mgo	Rotterdam	The Netherlands
Ayeavhd Oikofuwzoyl Umvknwlyvkvhj Prfqb	Parma	Italy
Usifhkvcnk Oh Arfkjdc	Edegem	Belgium
Uhghcvpfbphn Mcgbtxa Cqicmnh Glhsnfebf	Groningen	The Netherlands
Hmjefhry Uvvydxxikapow Dy Ly Pnqvpudg	Madrid	Spain
Iikjzoqk Cghlxk Dalygoocjddsmjelm	L'hospitalet De Llobregat	Spain
Hiqdxvug Vbgs dwqekhgq	Barcelona	Spain
Kdfinntoe Sbaqfen Sxcnlrgzigouxhi iq Jdah Pgemg Ib	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	05.11.2019
Czechia	Not recruiting	05.11.2019
France	Not recruiting	05.11.2019
Germany	Not recruiting	05.11.2019
Italy	Not recruiting	05.11.2019
Poland	Not recruiting	05.11.2019
Romania	Not recruiting	05.11.2019
Spain	Not recruiting	05.11.2019
The Netherlands	Not recruiting	05.11.2019

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, Nivolumab is being used to see if it can improve the outcomes for patients with a specific type of lung cancer when given before and after surgery.

Investigated diseases:

Non-small cell lung cancer

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 epithelial cells lining the lungs and is characterized by the formation of malignant tumors. The disease progresses as the cancer cells grow and spread to nearby tissues and organs, potentially reaching distant parts of the body through the bloodstream or lymphatic system. In its early stages, NSCLC may not cause noticeable symptoms, but as it advances, individuals may experience persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary significantly among individuals, influenced by factors such as the cancer’s subtype, stage at diagnosis, and overall health of the patient.

Trial ID:

2022-502658-15-00

Protocol code:

CA209-77T

NCT ID:

NCT04025879

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Chemotherapy with Nivolumab to Chemotherapy Alone for Patients with Resectable Non-small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?