Not recruiting

Study of sacituzumab govitecan and zimberelimab treatment before and after surgery for patients with resectable non-small cell lung cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with non-small cell lung cancer (NSCLC) that can be surgically removed. The study tests a combination treatment using two medications: sacituzumab govitecan and zimberelimab. These medications are given through an intravenous infusion, which means they are delivered directly into a vein.

The purpose of this study is to determine how effective the combination of these medications is at eliminating cancer cells before surgery. The treatment is given in two phases - before surgery (called neoadjuvant treatment) and after surgery (called adjuvant treatment). Before surgery, patients receive both medications. After surgery, all patients receive zimberelimab, and some patients may also continue receiving sacituzumab govitecan.

During the study, patients will receive regular medical examinations and various tests to monitor their health and how well the treatment is working. The treatment period may last up to 54 weeks. Zimberelimab is given at doses up to 360 milligrams, while sacituzumab govitecan is given based on the patient's body weight, up to 10 milligrams per kilogram of body weight.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase - neoadjuvant therapy
You will receive two medications through intravenous infusion:
- Zimberelimab (a type of immunotherapy)
- Sacituzumab govitecan (Trodelvy) (a targeted therapy medication)
This combined treatment aims to reduce the size of the lung cancer before surgery
Step 2
Pre-surgery evaluation
After completing the initial treatment, your medical team will perform imaging tests to assess how the tumor has responded to the therapy
These tests will help determine if the cancer has decreased in size and if surgery can proceed as planned
Step 3
Surgery
If the evaluation shows positive results, you will undergo surgery to remove the remaining tumor tissue
The surgical team will remove the tumor and nearby lymph nodes
The removed tissue will be examined to determine how well the initial treatment worked
Step 4
Post-surgery treatment - adjuvant therapy
After recovery from surgery, you will receive additional treatment
This will include Zimberelimab infusions
Some patients may also receive additional Sacituzumab govitecan treatments
The specific treatment plan will be determined based on your individual case
Step 5
Follow-up period
Regular check-ups will monitor your recovery and health status
Your medical team will track any side effects using standardized criteria
Quality of life assessments will be conducted using specific questionnaires
The total study duration may extend until June 2031

Who can join the trial?

10 criteria

Must be at least 18 years old when signing the consent form
Must have confirmed non-small cell lung cancer that can be surgically removed, at stages II to IIIB
Must have completed all required tests including: - Tissue sampling through the airways (EBUS) - PD-L1 testing of tumor tissue - Special imaging scans (PET-CT and brain MRI)
Must have adequate blood test results showing: - Hemoglobin level of at least 9 g/dL - White blood cell count (ANC) of at least 1500/mm3 - Platelet count of at least 100,000/μL
Must have proper liver function with: - Bilirubin not more than 1.5 times the normal limit - Liver enzymes (AST and ALT) not more than 2.5 times the normal limit
Must have adequate kidney function with creatinine clearance of at least 30 mL/min
Must be able to undergo treatment before surgery and additional treatment after surgery
Must have good physical performance status (ECOG score of 0-1, meaning able to perform daily activities)
Must provide written informed consent and be able to follow study requirements
For women who can become pregnant: - Must use reliable birth control during the study and for 6 months after - Must not be breastfeeding - Women who cannot become pregnant must provide proof through either: - Being post-menopausal (over 50 and no periods for 12 months) - Having had surgery to remove the uterus or ovaries

Who cannot join the trial?

13 criteria

Prior treatment with any chemotherapy (medications used to kill cancer cells) for lung cancer
Active or untreated brain metastases (cancer that has spread to the brain)
History of other cancers within the past 3 years, except for successfully treated skin cancer or early-stage cancer
Severe heart conditions including heart failure, unstable heart disease, or heart attack in the past 6 months
Active or chronic infections including hepatitis B, hepatitis C, or HIV
Significant liver problems or abnormal liver function tests
Severe kidney disease requiring dialysis
Autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
Pregnancy or breastfeeding
Known allergies to the study medications or their components
Participation in other clinical trials within 30 days before starting this study
Mental conditions that could interfere with following study procedures
Any condition that the study doctor believes would make participation unsafe

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Goethe University Frankfurt
Verified
Frankfurt, Germany
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
Verified
Essen, Germany

Trial locations

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Investigated drugs

Sacituzumab govitecan
is a medication that combines an antibody with an anti-cancer drug. It works by targeting a specific protein found on cancer cells and delivering the cancer-fighting medication directly to these cells. It's used in the treatment of non-small cell lung cancer.
Zimberelimab
is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking certain proteins that prevent immune cells from attacking cancer, allowing the immune system to better recognize and destroy cancer cells. It's used both before and after surgery in this trial for treating non-small cell lung cancer.

What is already known about the treatment

Sacituzumab govitecan
An antibody-drug conjugate administered intravenously that combines a targeted antibody with a potent chemotherapy drug, specifically designed for cancer treatment. This medication works by delivering the chemotherapy component directly to cancer cells that express the Trop-2 protein, which is commonly found in non-small cell lung cancer cells, while minimizing damage to healthy tissues. Currently, it represents an innovative approach in cancer therapy, showing promising results in clinical trials for treating non-small cell lung cancer in combination with immunotherapy.
Zimberelimab
A monoclonal antibody administered through intravenous infusion that belongs to the class of immune checkpoint inhibitors. This medication works by blocking the PD-1 protein on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. It is being studied in clinical trials for the treatment of non-small cell lung cancer, both as a neoadjuvant therapy before surgery and as an adjuvant therapy after surgery, demonstrating potential in improving patient outcomes when used alone or in combination with other cancer treatments.

Investigated diseases

Non-small cell lung cancer - A type of lung cancer that begins in the cells of the lungs and gradually forms tumors. It develops when healthy cells in the lung tissue begin to grow uncontrollably, creating masses that interfere with normal lung function. This disease typically starts in the cells that line the airways of the lungs, known as the bronchi and bronchioles. The cancer can spread from its original location to nearby tissues and other parts of the body. Non-small cell lung cancer accounts for the majority of all lung cancer cases and generally grows and spreads more slowly than small cell lung cancer.