Study of Farletuzumab Ecteribulin for Patients with Metastatic Non-Small Cell Lung Cancer After Previous Treatments

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as metastatic non-small cell lung cancer (NSCLC), specifically the adenocarcinoma subtype. The treatment being tested is called MORAb-202, also known as farletuzumab ecteribulin. This treatment is a special kind of medication called an antibody-drug conjugate, which is designed to target cancer cells more precisely. The purpose of the study is to evaluate the safety and how well this treatment works in patients who have already received other treatments for their cancer.

Participants in the study will receive the treatment as a solution for injection through a method called intravenous infusion, which means it is given directly into a vein. The study will monitor how patients respond to the treatment and any side effects they may experience. This will help researchers understand the potential benefits and risks of using MORAb-202 for treating this type of lung cancer.

The study is open-label, meaning both the researchers and participants know what treatment is being given. It is randomized, which means participants are assigned to different groups by chance. This helps ensure the results are fair and reliable. The study will continue for a period of time to gather enough information to make informed conclusions about the treatment’s effectiveness and safety.

1 joining the study

Upon joining the study, the participant must have signed a written informed consent. This document confirms understanding and agreement to participate in the study.

Participants must provide either a tissue block, unstained slides, or a new biopsy for assessment before randomization.

2 initial assessment

An initial assessment is conducted to confirm the diagnosis of metastatic non-small cell lung cancer (NSCLC) adenocarcinoma.

The disease progression is documented through radiological methods, and measurable target disease is assessed according to specific criteria.

3 treatment administration

The treatment involves the administration of farletuzumab ecteribulin through an intravenous infusion. This is a solution for injection.

The frequency and duration of the treatment are determined by the study protocol and the participant’s response to the treatment.

4 monitoring and follow-up

Participants are monitored for any adverse events or side effects. This includes regular check-ups and laboratory tests to ensure safety and tolerability.

The response of the tumor to the treatment is assessed periodically to determine the effectiveness of the therapy.

5 completion of the study

The study is estimated to end by May 1, 2026. Participants will continue to be monitored until the study’s conclusion.

Upon completion, participants may undergo a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

Participants or their legally acceptable representatives must have signed a Written Informed Consent, which is a document that explains the study and confirms their agreement to participate.
Participants must provide a sample of their tumor tissue, which can be a block of tissue, slides, or a new biopsy, for testing in a central laboratory before being assigned to a treatment group.
Participants must be 18 years or older at the time they sign the informed consent.
Participants must have a confirmed diagnosis of metastatic non-small cell lung cancer adenocarcinoma, which means the cancer has spread from the lungs to other parts of the body.
Their disease must have shown progression, meaning it has gotten worse, during or after their last treatment, as assessed by a doctor using imaging tests.
Participants must have measurable disease, which means the cancer can be measured using specific criteria called RECIST 1.1.
If participants have had treatments like external beam radiotherapy or radiofrequency ablation, the treated areas must show signs of disease progression to be considered for the study.
Participants must have an ECOG Performance Status of 0 or 1, which indicates they are fully active or have some restrictions but can still carry out light activities.
Participants must have received previous treatments, including chemotherapy with platinum-based drugs. If they do not have specific genetic changes or their genetic status is unknown, they must have been treated with drugs targeting PD-1/PD-L1. If they have known genetic changes, they must have received at least one targeted therapy.
Participants must not have received more than three different types of systemic therapy for their metastatic cancer. If their cancer was initially treatable or locally advanced and returned or worsened within a year after starting treatment, they do not need to be retreated to join the study.

Who Cannot Join the Study?

Patients who have not been previously treated for their lung cancer.
Patients with a type of lung cancer other than metastatic non-small cell lung cancer. Metastatic means the cancer has spread to other parts of the body.
Patients who are not able to safely tolerate the study treatment.
Patients who are not able to have their tumor response assessed during the study.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who are part of a vulnerable population that the study cannot safely include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hospital Foch	Suresnes	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hkjkiwql Vfuq dwccxvij	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	29.03.2023
Spain	Not recruiting	29.03.2023

Trial locations

Investigated drugs:

Farletuzumab Ecteribulin

MORAb-202 (Farletuzumab Ecteribulin) is a medication being studied for its effects on metastatic non-small cell lung cancer (NSCLC) adenocarcinoma. It is an antibody-drug conjugate that targets folate receptor alpha, which is often found on cancer cells. The purpose of this medication in the trial is to evaluate its safety and how well it is tolerated by patients who have already received other treatments. Additionally, the trial aims to assess how effectively MORAb-202 can reduce or control the growth of tumors in these patients.

Investigated diseases:

Non-small cell lung cancer

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that has spread from the lungs to other parts of the body. It originates in the lung tissues and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can invade nearby tissues and organs, leading to further complications. The term “non-small cell” refers to the specific type of cells involved, which differ from those in small cell lung cancer. Metastasis indicates that the cancer has moved beyond its original site, often affecting organs such as the brain, bones, or liver. The progression of this disease can vary, with symptoms often worsening as the cancer spreads.

Trial ID:

2023-504112-15-00

Protocol code:

CA116-003

NCT ID:

NCT05577715

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Farletuzumab Ecteribulin for Patients with Metastatic Non-Small Cell Lung Cancer After Previous Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?