Study on Durvalumab and Platinum-Based Drug Combination for Patients with Stage IIB-IIIB Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that is common and can be challenging to treat. The study is testing a treatment approach that includes a medication called durvalumab, which is used to help the immune system fight cancer, along with platinum-based chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. The study aims to see how effective this combination is in treating patients with NSCLC that can be surgically removed or is close to being removable.

Participants in the study will first receive durvalumab and chemotherapy before undergoing surgery or a combination of chemotherapy and radiation therapy, known as chemoradiotherapy (CRT). After these treatments, they will continue to receive durvalumab to help prevent the cancer from returning. The study will last for several months, and participants will be closely monitored by healthcare professionals throughout the process. The goal is to determine how well this treatment plan works in increasing the chances of successful surgery and improving overall outcomes for patients with NSCLC.

Other medications involved in the study include pemetrexed, paclitaxel, carboplatin, gemcitabine, cisplatin, docetaxel, vinorelbine, infliximab, and mycophenolate mofetil. These drugs are used in various combinations to treat cancer and support the immune system. The study is designed to assess the effectiveness of these treatments in improving the surgical outcomes and overall health of patients with NSCLC.

1 initial treatment phase

The initial phase involves the administration of neoadjuvant durvalumab combined with platinum-based chemotherapy. This treatment is designed to shrink the tumor before any surgical intervention.

The medications are administered through intravenous infusion. The specific drugs used in this phase include pemetrexed, paclitaxel, carboplatin, gemcitabine, and cisplatin.

2 surgical or chemoradiotherapy decision

After the initial treatment phase, a decision is made regarding the next step: either proceed with surgery or continue with chemoradiotherapy (CRT).

This decision is based on the response to the initial treatment and the resectability of the tumor.

3 surgery and adjuvant treatment

If surgery is chosen, it is followed by adjuvant durvalumab treatment to help eliminate any remaining cancer cells.

The surgery aims to remove the tumor completely, and the adjuvant treatment is administered to prevent recurrence.

4 chemoradiotherapy and consolidation treatment

If chemoradiotherapy is chosen, it is followed by consolidation durvalumab treatment.

This phase aims to consolidate the effects of CRT and further reduce the risk of cancer returning.

5 follow-up and monitoring

Throughout the trial, regular follow-up appointments are scheduled to monitor health status and response to treatment.

These appointments include various assessments such as imaging tests and blood work to ensure the treatment is effective and to manage any side effects.

Who Can Join the Study?

Participants must be at least 18 years old at the time of screening.
Participants should have adequate heart and lung function, as determined by a team of specialists. This includes specific lung function tests called FEV1 and DLCO.
Participants must weigh at least 30 kg.
Both males and females can participate. They must follow local rules for birth control during the study.
Females of child-bearing potential must have a negative pregnancy test.
Female participants must be postmenopausal, surgically sterile, or using a highly effective method of birth control.
Male participants must be surgically sterile or use an acceptable method of birth control to prevent pregnancy in a partner.
Participants must be able to give informed consent, agreeing to follow the study’s requirements.
Participants must provide signed and dated written consent before any samples are collected.
All races, genders, and ethnic groups are eligible for the study.
Participants must have a confirmed diagnosis of Non-small Cell Lung Cancer (NSCLC) through specific tests.
The cancer must be considered resectable or borderline resectable, confirmed by a team of specialists.
The cancer must be at stage IIB to certain stage IIIB, and participants must not have received prior treatment for it.
Participants must have a performance status of 0 or 1, meaning they are fully active or have some restrictions but can still do light work.
Participants must not have certain genetic mutations known as EGFR or ALK mutations.
Participants must have at least one measurable lesion that has not been previously treated with radiation.
Participants must have adequate organ and bone marrow function, as shown by specific blood tests.
Participants must have a minimum life expectancy of 12 weeks.

Who Cannot Join the Study?

Patients with other types of cancer besides Non-small Cell Lung Cancer (NSCLC) cannot participate.
Patients with medical conditions that make surgery impossible or unsafe cannot participate.
Patients who have received certain treatments that might interfere with the study cannot participate.
Patients with severe or uncontrolled health problems that could affect their safety during the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend required visits cannot participate.
Patients with a history of allergic reactions to the study drugs cannot participate.
Patients who are participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Koranyi National Institute For Pulmonology	Budapest	Hungary
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH	Berlin	Germany
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Da Luz S.A.	Lisbon	Portugal
Fakultni Nemocnice Brno	Brno	Czechia
Karolinska University Hospital	Solna	Sweden
Hospital Universitario De Cruces	Barakaldo	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Hopital Saint Joseph	Marseille	France
Hospital Cuf Tejo S.A.	Lisbon	Portugal
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.	Peschiera Del Garda	Italy
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
University Hospital Olomouc	Olomouc	Czechia
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l.	Palermo	Italy
Klinikum Wuerzburg Mitte gGmbH	Wuerzburg	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Sormjenu Ksfmliuziye Bfmridfmc Fbta Dst Gihvthpigt Miwyh	Moers	Germany
Ibbhwsin Cdgdpg Dzikwesgalhyeegwp	L'hospitalet De Llobregat	Spain
Fnjfjvga nfdzqwlhu Mgqdg a Hufptaw	Prague	Czechia
Ujjhdlj Uldyggqhek Hgpzvdmk	Uppsala	Sweden
Aknertx Usvxi Scdtyxvak Luidhf Dj Bpcdoae	Bologna	Italy
Hljgufeg Db Lw Slwmx Cgsb I Skta Pte	Barcelona	Spain
Fspyderjl Pekh Lk Idykttdllslgk Bhaedxyso Dqk Hztjulcv Uymtawdsjvbny Lz Pvb	Madrid	Spain
Iglhynpy Cwgrt	Paris	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	29.12.2023
Czechia	Not recruiting	29.12.2023
France	Not recruiting	29.12.2023
Germany	Not recruiting	29.12.2023
Hungary	Not recruiting	29.12.2023
Italy	Not recruiting	29.12.2023
Portugal	Not recruiting	29.12.2023
Spain	Not recruiting	29.12.2023
Sweden	Not recruiting	29.12.2023

Trial locations

Investigated drugs:

Durvalumab is a medication used in this trial to help the body’s immune system fight cancer. It is given to participants before surgery to shrink the tumor and make it easier to remove. After surgery, it is also used to help prevent the cancer from coming back.

Platinum-Based Chemotherapy refers to a group of cancer-fighting drugs that contain the metal platinum. These medications are used in combination with durvalumab before surgery to help reduce the size of the tumor in the lungs, making it easier to remove.

Chemoradiotherapy (CRT) is a treatment that combines chemotherapy and radiation therapy. In this trial, it is used as an alternative to surgery for some participants. The goal is to destroy cancer cells and reduce the tumor size, which can help control the disease.

Consolidation Durvalumab is the continued use of durvalumab after initial treatments like surgery or chemoradiotherapy. This is done to help maintain the benefits of the initial treatment and to reduce the risk of the cancer returning.

Investigated diseases:

Non-small cell lung cancer

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 all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:

2023-503357-35-00

Protocol code:

D9106C00002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Durvalumab and Platinum-Based Drug Combination for Patients with Stage IIB-IIIB Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?