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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Asklepios Klinik Gauting GmbH	Gauting	Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH	Berlin	Germany
Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie (GEHO)	Munster	Germany
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Saarland University Hospital	Homburg	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
SLK-Kliniken GmbH – Standort Fachklinik Löwenstein	Loewenstein	Germany
Uifbojvgukgwpdkeafwfs Etgkg Aup	Essen	Germany
Cdwjmnouzofabgx Hjurfpkv	Cologne	Germany
Grkpie Uzdkteozom Fzokyosjb	Frankfurt	Germany
Ktpgdyje Eragixxgyrzvzryplmojhzsn Hdymfvyvkpjjxondz	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	30.06.2025

Trial locations

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.

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.

Trial ID:

2024-517561-16-00

Protocol code:

AIO-TRK/YMO-0224

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?