Study of Volrustomig and Drug Combination 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 treatments for Non-small Cell Lung Cancer (NSCLC), specifically in its early stages where the cancer can be surgically removed. The study involves several medications, including volrustomig (also known as MEDI5752), carboplatin, AZD0171 (also known as falbikitug), paclitaxel, datopotamab deruxtecan (also known as DS-1062a or Dato-DXd), pemetrexed, cisplatin, durvalumab (also known as MEDI4736 or IMFINZI™), oleclumab (also known as MEDI9447), and monalizumab (also known as IPH2201). These treatments are given as solutions for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the effectiveness and safety of these treatments when given before and after surgery. The study will follow a course where patients receive the treatments before surgery to shrink the tumor, known as neoadjuvant treatment, and then continue with additional treatments after surgery, known as adjuvant treatment. The study aims to see how well these treatments work in reducing the cancer and how safe they are for patients.

Participants in the study will receive either the active medications or a placebo. The study will monitor the response of the cancer to the treatments, as well as any side effects experienced by the participants. The goal is to gather information that could help improve treatment options for patients with early-stage NSCLC that can be surgically removed.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as having resectable non-small cell lung cancer (NSCLC) at stages IIA to IIIB, adequate organ function, and a performance status of 0 or 1.

Tumor samples are required to confirm specific cancer markers.

2 neoadjuvant treatment

Neoadjuvant treatment involves administering medications before surgery to reduce the size of the tumor.

Medications include volrustomig, carboplatin, falbikitug, paclitaxel, datopotamab deruxtecan, cisplatin, durvalumab, oleclumab, and monalizumab, all given through intravenous infusion.

The goal is to assess the reduction of viable tumor cells.

3 surgery

Surgery is planned to occur within 40 days after the last dose of neoadjuvant treatment.

The aim is to remove the tumor and assess the presence of any remaining cancer cells.

4 adjuvant treatment

Adjuvant treatment is administered after surgery to eliminate any remaining cancer cells and reduce the risk of recurrence.

The same medications used in the neoadjuvant phase may be continued, depending on individual response and tolerance.

5 follow-up and monitoring

Regular follow-up visits are scheduled to monitor health status, check for any side effects, and assess the effectiveness of the treatment.

This phase includes evaluating vital signs, laboratory tests, and imaging studies to ensure safety and track progress.

Who Can Join the Study?

  • Patients must have been newly diagnosed with a type of lung cancer called Non-small Cell Lung Cancer (NSCLC) that can be surgically removed. The cancer should be in an early stage, specifically from Stage IIA to Stage IIIB.
  • Patients should have a performance status of 0 or 1 according to the WHO or Eastern Cooperative Oncology Group (ECOG) scale. This means they should be fully active or have some symptoms but still be able to carry out light work.
  • Patients need to have adequate organ and bone marrow function, which means their organs and bone marrow are working well enough to handle the treatment.
  • Patients must provide samples of their tumor, either newly taken or from the last 6 months, to check for specific markers like Programmed death-ligand 1 (PD-L1), epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK). These are proteins or genes that can affect how the cancer behaves and responds to treatment.
  • Patients should have adequate pulmonary function, meaning their lungs should be working well enough to handle the treatment and surgery.
  • Both male and female patients are eligible to participate.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not Non-small Cell Lung Cancer.
  • Patients with lung cancer that is not in the early stages (II to IIIB).
  • Patients whose lung cancer cannot be surgically removed (resectable).
  • Patients who have received other treatments for lung cancer before the study.
  • Patients with serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Hospitalier Universitaire Rouen Rouen France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Hospital Foch Suresnes France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Azienda Ospedaliera Di Perugia Perugia Italy
Az Maria Middelares Gent Gent Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Grand Hopital De Charleroi Charleroi Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Centre Hospitalier D Avignon Avignon France
HIA Sainte Anne Toulon France
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Da Luz S.A. Lisbon Portugal
Champalimaud Clinical Centre Lisbon Portugal
University Hospital Galway Galway Ireland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Salut Sant Joan De Reus Reus Spain
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Universita Degli Studi Di Brescia Brescia Italy
Beaumont Hospital Dublin Ireland
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Bzvxcdfirbr Vmzgvuvpn Onqbdffxcnec Kecskemet Hungary
Crucbg Hseicfdxstr Er Ufntpoohnyegh Dj Ljssoqs Limoges France
Iuhsjasf Racosluxz Pce Lf Skaiiy Ddu Ttfrdg Dwym Afwlevf Iupl Scntoj Meldola Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
10.06.2022
France France
Recruiting
10.06.2022
Hungary Hungary
Recruiting
10.06.2022
Ireland Ireland
Recruiting
10.06.2022
Italy Italy
Recruiting
10.06.2022
Portugal Portugal
Recruiting
10.06.2022
Spain Spain
Recruiting
10.06.2022

Trial locations

Durvalumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

Tremelimumab is another medication in the trial that helps boost the immune system’s response against cancer. It works by targeting a specific protein that can suppress the immune system, thereby enhancing the body’s ability to fight cancer cells.

Oleclumab is included in the trial to target and block a protein that is involved in the growth and spread of cancer cells. By inhibiting this protein, the medication aims to slow down or stop the progression of the cancer.

Monalizumab is used in the trial to enhance the immune system’s ability to attack cancer cells. It works by blocking a protein that can inhibit immune responses, thus promoting a stronger attack on the cancer by the body’s natural defenses.

Non-small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is called “non-small cell” to distinguish it from small cell lung cancer, which behaves differently. In early stages, the cancer is typically confined to the lungs and may not cause noticeable symptoms. As it progresses, it can spread to nearby tissues and lymph nodes. The disease is often detected through imaging tests when symptoms like persistent cough, chest pain, or shortness of breath appear. Early-stage non-small cell lung cancer is considered resectable, meaning it can potentially be removed through surgery.

Trial ID:
2023-508852-21-00
Protocol code:
D9077C00001
NCT ID:
NCT05061550
Trial Phase:
Therapeutic exploratory (Phase II)

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