Study of Zelenectide Pevedotin in Adults with Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer with NECTIN4 Amplification

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What is this study about?

This clinical trial focuses on studying advanced or metastatic non-small cell lung cancer with a specific genetic characteristic called NECTIN4 amplification. The study tests a new medication called zelenectide pevedotin (also known as BT8009) in patients who have already received previous treatments for their cancer. The medication is given through intravenous infusion, which means it is administered directly into a vein.

The main purpose of this study is to determine how well zelenectide pevedotin works in treating patients whose tumors have this specific NECTIN4 amplification. The medication is a type of drug called a bicyclic peptide, which is designed to target specific cancer cells. The study will include patients with two different types of non-small cell lung cancer: squamous and non-squamous forms of the disease.

During the study, participants will receive zelenectide pevedotin through intravenous infusion. The treatment will be given in cycles, with regular medical check-ups to monitor the patient’s health and how well the treatment is working. The maximum dose that can be given is 6 milligrams per square meter of body surface area. The study team will track if the tumors shrink, stay the same size, or grow during the treatment period.

1 Initial medical assessment

Your eligibility will be confirmed through medical tests and examination

Your cancer must be confirmed as advanced or metastatic non-small cell lung cancer

A NECTIN4 gene test will be performed to confirm if your tumor has the required genetic characteristics

Basic health measurements will be taken, including blood tests, liver and kidney function tests

2 Pre-treatment requirements

A tumor tissue sample will be collected or previous samples will be used for laboratory testing

Your oxygen level must be at least 93% when breathing room air

Pregnancy test is required for women who can become pregnant

You must agree to use effective birth control methods during the study and for 6.5 months after the last dose

3 Treatment administration

Zelenectide pevedotin (BT8009) will be given through an intravenous infusion

The medication comes as a powder that will be prepared as a solution for infusion

Regular assessments of your tumor response will be conducted using imaging scans

Your overall health status will be monitored throughout the treatment

4 Ongoing monitoring

Regular blood tests will check your bone marrow function

Your liver and kidney function will be monitored regularly

The medical team will track any side effects you may experience

Imaging scans will be performed to measure how your tumor responds to treatment

5 Post-treatment follow-up

You will be monitored for at least 6.5 months after your last treatment dose

Continue using birth control methods during this period

Regular check-ups will assess your long-term health status

Your survival and disease progression will be tracked

Who Can Join the Study?

Must be at least 18 years old
Must be able to understand and agree to participate in the study by signing an informed consent form
Must have confirmed advanced or metastatic non-small cell lung cancer (cancer that has spread to other parts of the body)
Must have a specific genetic feature called NECTIN4 gene amplification confirmed by testing
Must not have received more than 3 previous treatments for advanced cancer
Must have measurable tumors that can be evaluated using specific criteria (RECIST v1.1)
Must provide tumor tissue samples for laboratory testing
Must have a life expectancy of at least 12 weeks
Must have good physical functioning ability (ECOG score of 0 or 1)
Must have adequate oxygen levels (93% or higher) when breathing room air
Must have adequate liver, kidney, and blood function based on specific laboratory tests
Must have normal blood clotting function, unless on stable anticoagulation therapy
Must have adequate bone marrow function showing acceptable levels of:
- Red blood cells (hemoglobin)
- White blood cells (neutrophils)
- Platelets
If of childbearing potential, must have a negative pregnancy test
Must agree to use effective birth control during the study and for 6.5 months after the last dose
Must not donate sperm or eggs during the study and for 6.5 months after the last dose
Women must not breastfeed during the study and for 6.5 months after the last dose

Who Cannot Join the Study?

Age below 18 years or above 75 years
Prior treatment with zelenectide pevedotin (the study medication)
Absence of NECTIN4 amplification in tumor tissue (a specific genetic marker)
Current participation in other clinical trials
Known allergies to similar medications
Presence of brain metastases (cancer spread to the brain) that are not stable or treated
Significant heart problems or uncontrolled high blood pressure
Active infections requiring treatment
Major surgery within 4 weeks before starting the study
Pregnancy or breastfeeding
Inability to follow study procedures or attend scheduled visits
Severe liver or kidney dysfunction
History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Use of medications that could interfere with the study drug
Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Intercommunal Creteil	Creteil	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Universita’ Politecnica Delle Marche	Ancona	Italy
Clxkyj Luyd Bwglzr	Lyon	France
Idceca Icvrkbrm Fynqkfeucrnzj Oumnxqtketz	Rome	Italy
Uvctgsffhc Hfhrrrtk Capepux	Cologne	Germany
Heznyeud Uixucckmzfayq dl A Cftdes	A Coruna Galicia	Spain
Hrwfxdsf Utsovzfywxvquf Szgglzflzd &kbksbi Hidwhes dy Hjywkcxnwkd	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.08.2025
Germany	Not recruiting	31.08.2025
Italy	Not recruiting	31.08.2025
Spain	Not recruiting	31.08.2025

Trial locations

Investigated drugs:

ZELENECTIDE PEVEDOTIN

Zelenectide pevedotin is an investigational drug being studied for the treatment of non-small cell lung cancer. It specifically targets tumors that have increased levels of a protein called NECTIN4. This medication belongs to a class of drugs known as antibody-drug conjugates, which combine an antibody that targets specific cancer cells with a drug that can kill those cells. It is designed to work in patients whose cancer has already been treated with other therapies and has either spread to other parts of the body or is at an advanced stage.

Non-small Cell Lung Cancer – A type of lung cancer that begins in the large cells outside of the small cells in the lungs. It develops when healthy cells in the lung tissue begin to grow uncontrollably and form masses called tumors. The disease can spread from its original location to other parts of the body through the blood or lymph system, which is known as metastasis. Advanced or metastatic forms indicate that the cancer has spread beyond its initial location in the lungs to other parts of the body. This cancer typically grows and spreads more slowly than small cell lung cancer. Non-small cell lung cancer accounts for the majority of all lung cancer cases.

Trial ID:

2025-521115-40-00

Protocol code:

BT8009-202

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Zelenectide Pevedotin in Adults with Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer with NECTIN4 Amplification

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?