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Study of Chemotherapy and Nivolumab for Patients with Locally Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The study is investigating the effects of combining chemotherapy with a type of treatment called immunotherapy, compared to using chemotherapy alone. The immunotherapy drug being used in this study is called nivolumab, which is also known by its code name BMS936558. Nivolumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if the combination of chemotherapy and immunotherapy can lead to a better response in patients with NSCLC that is located in the chest and can potentially be removed by surgery. The study will compare the presence of any remaining cancer in the lungs and lymph nodes between patients receiving the combination treatment and those receiving only chemotherapy. Participants in the study will receive treatment over a period of time, and their health will be monitored to assess the effectiveness and safety of the treatments.

Throughout the study, researchers will also look at other important factors such as overall survival, how long patients live without the cancer getting worse, and the rate of significant responses to the treatment. They will also examine how the treatment affects the need for surgery, the length of hospital stays, and any side effects related to the surgery. The study aims to provide valuable information on how well the combination of chemotherapy and immunotherapy works for treating NSCLC and to understand the relationship between the treatment and the type of lung cancer.

1 joining the study

Upon joining the study, the patient will be informed about the investigational nature of the trial and will sign a written informed consent.

Eligibility criteria include being over 18 years old, having a confirmed diagnosis of non-small cell lung cancer (NSCLC) at stage IIIA or IIIB, and having a tumor considered resectable by a multidisciplinary team.

2 initial assessment

The patient will undergo an initial assessment to confirm measurable or evaluable disease according to specific criteria.

A performance status evaluation will be conducted to ensure the patient is capable of proper therapeutic compliance.

3 treatment phase

The treatment phase involves receiving either a combination of chemotherapy and immunotherapy or chemotherapy alone.

The immunotherapy used is nivolumab, administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

4 monitoring and follow-up

Throughout the treatment, the patient will be monitored for any adverse events and the effectiveness of the treatment.

Regular follow-up visits will be scheduled to assess the patient’s response to the treatment and to ensure safety and tolerability.

5 surgery evaluation

After the treatment phase, the patient will be evaluated to determine if surgery is feasible.

The primary goal is to achieve a pathological complete response, which means no residual tumor in the lung and lymph nodes.

6 post-surgery follow-up

If surgery is performed, the patient will be monitored for recovery and any potential complications.

The study will continue to follow the patient’s overall survival and progression-free survival, as well as other secondary endpoints.

Who Can Join the Study?

  • Patients must have non-small cell lung cancer (NSCLC) that has not been treated before.
  • The cancer should be at stage IIIA or stage IIIB with specific characteristics, meaning it is advanced but still possibly removable by surgery.
  • The tumor must be considered resectable, which means it can be surgically removed, as determined by a team of medical experts.
  • Patients should have an ECOG performance status of 0-1, which indicates they are fully active or have some symptoms but do not need bed rest.
  • Patients must have normal blood, liver, and kidney function.
  • Participants must be informed about the study and sign a written informed consent, agreeing to participate.
  • Patients must be over 18 years old.
  • Women who can have children must have a negative pregnancy test before starting the treatment.
  • All sexually active men and women who can have children must use an effective birth control method during the study and for at least 12 months after the last treatment.
  • Patients must be able to follow the treatment plan correctly and be available for follow-up visits.

Who Cannot Join the Study?

  • Patients with other types of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a common type of lung cancer.
  • Patients who have had previous treatments that might interfere with the study results are not eligible.
  • Patients with serious health conditions that could make participation unsafe are excluded.
  • Patients who are unable to follow the study procedures or attend required visits cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have allergies or reactions to the study medications are excluded.
  • Patients who are part of another clinical trial at the same time cannot participate.
  • Patients with a history of drug or alcohol abuse that could affect the study are not eligible.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period are excluded.
  • Patients with certain infections that could interfere with the study are not allowed to participate.

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 De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Hospital General Universitario De Alicante Alicante Spain
Hospital Clinico Universitario De Valencia Valencia Spain
Hospital Universitario Reina Sofía Cordoba Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital General Universitario De Valencia Valencia Spain
Iexaskzt Ctokiy Drgbtjhwafblkaxhi L'hospitalet De Llobregat Spain
Cyhdbxdq Hikuristxdgh Uwoqbmnkpdfah Do Vdvs Vigo Spain
Hztztrzx Uupnsletlvsrl Ronyrhko Ds Mnpwtq Malaga Spain
Hzsssuhe Dl Ly Sqqow Cbmi I Svuv Plp Barcelona Spain
Fctscchwv Pnll Le Inwkrjwpqkfbu Bcxiksbjm Dcp Hksnftuq Unfleswzpumvt Lk Ptd Madrid Spain
Higgcvkd Vdtn dctolxki Barcelona Spain
Hgecjwsg Ujhtzmzioqdwt dj A Cvgngi A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
03.06.2024

Trial locations

Investigated drugs:

Chemo-immunotherapy is a combination treatment that uses both chemotherapy and immunotherapy to fight cancer. Chemotherapy involves using drugs to kill cancer cells or stop them from growing. Immunotherapy helps the body’s immune system recognize and attack cancer cells more effectively. In this trial, chemo-immunotherapy is being tested to see if it can improve outcomes for patients with locally advanced non-small cell lung cancer.

Chemotherapy is a treatment that uses powerful drugs to kill cancer cells or stop them from growing and dividing. It is a standard treatment for many types of cancer, including non-small cell lung cancer. In this trial, chemotherapy is being used alone to compare its effectiveness against the combination of chemo-immunotherapy.

Non-small cell lung cancer (NSCLC) – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically begins in the epithelial cells lining the lungs and can spread to other parts of the body. NSCLC progresses through stages, starting from a localized tumor to more advanced stages where it may invade nearby tissues or spread to distant organs. The disease is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the type of cells involved. Symptoms may include a persistent cough, chest pain, and shortness of breath, but they often appear only after the disease has advanced. Early detection is challenging, as initial stages may not present noticeable symptoms.

Trial ID:
2024-513731-24-00
NCT ID:
NCT03838159
Trial Phase:
Therapeutic exploratory (Phase II)

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