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Study of Sacituzumab and Zimberelimab for Patients with Resectable Non-Small Cell Lung Cancer After Surgery Without Complete Disease Clearance

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What is this trial about?

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

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The trial involves patients who have undergone surgery to remove the cancer but were not completely free of the disease afterward. The study will use two treatments: Sacituzumab Govitecan and Zimberelimab. Sacituzumab Govitecan is a medication that targets cancer cells, while Zimberelimab is an immunotherapy drug that helps the immune system fight cancer.

The purpose of the study is to evaluate how well these treatments work in preventing the return of cancer and improving survival rates. Participants will receive these treatments through an infusion, which means the medication is given directly into the bloodstream. The study will last for up to 12 months, during which time the participants will be monitored for any signs of cancer returning or any new lung cancer developing.

Throughout the study, the safety and tolerability of the combination of Sacituzumab Govitecan and Zimberelimab will be closely observed. The goal is to understand how these treatments can help patients live longer without the disease coming back. Participants will be followed up at regular intervals to check their overall health and response to the treatment.

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
Joining the study
Upon joining the study, the patient is required to have a confirmed diagnosis of non-small cell lung cancer (NSCLC) and must have undergone complete surgical removal of the tumor.
The patient must not have achieved a complete response to previous treatments and should be classified in specific stages of cancer according to medical guidelines.
Step 2
Pre-treatment assessment
Before starting the treatment, the patient undergoes a series of assessments to confirm eligibility, including imaging tests to ensure there is no distant disease.
Laboratory tests are conducted to verify adequate blood and organ function.
Step 3
Treatment initiation
The treatment begins between the 3rd and 10th week after surgery. The patient receives two medications: Zimberelimab and Sacituzumab Govitecan, both administered through an intravenous infusion.
The specific dosage and frequency of administration are determined by the medical team based on the patient's condition and response to treatment.
Step 4
Treatment duration
The treatment continues for a period specified by the medical team, with regular monitoring to assess the patient's response and any side effects.
The primary goal is to evaluate the length of time the patient remains free from disease recurrence or new lung cancer.
Step 5
Follow-up and monitoring
Throughout the study, the patient is regularly monitored for overall survival and the safety and tolerability of the treatment.
Follow-up assessments occur at 12, 24, and 36 months after the start of the treatment to evaluate long-term outcomes.

Who can join the trial?

20 criteria

Patients must have been diagnosed with primary non-small cell lung cancer, confirmed by examining tissue samples.
Patients should be classified after surgery in specific stages (IB, IIA, IIB, IIIA, or IIIB) based on the size and spread of the cancer.
Complete surgical removal of the primary lung cancer is necessary. Surgeons should collect samples from specific lymph node areas during surgery.
The surgery can include different types of lung removal, such as lobectomy or pneumonectomy, but not smaller procedures unless complete removal is confirmed.
Patients who did not achieve a complete response to treatment before surgery are eligible.
Patients must have received a combination of chemotherapy and immunotherapy before surgery.
Radiation therapy before or after surgery is not allowed for this study.
At least 3 weeks should pass between surgery and the start of the study, with treatment beginning between the 3rd and 10th week after surgery.
Patients should have a performance status of 0-1, meaning they are fully active or have some restrictions but can still perform light activities.
Patients must be 18 years or older.
The PDL1 value, a specific protein level, should be analyzed locally.
A PET-CT and brain CT scan must be done before starting the study to ensure the cancer hasn't spread to other parts of the body.
Patients must have adequate blood and organ function, confirmed by lab tests within 14 days before starting the study.
Patients must be informed about the study and sign a consent form agreeing to participate.
Women who can have children must agree to use effective birth control during the study and for 6 months after the last treatment.
Men with partners who can have children must also agree to use effective birth control during the study and for 6 months after the last treatment. They should not donate sperm during this time.
Oral birth control should be combined with another method due to possible interactions with study drugs. Men must use a condom if their partner can have children.
Women who are not postmenopausal or surgically sterile must have a negative pregnancy test before starting the study.
Patients must be able to follow the treatment plan and attend follow-up appointments.
Patients should have a life expectancy of more than 12 weeks.

Who cannot join the trial?

8 criteria

Patients with a type of lung cancer that cannot be surgically removed.
Patients who have had a recurrence of lung cancer or any new lung cancer.
Patients who have experienced any other type of cancer in the past.
Patients who have a serious illness or medical condition that could interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a known allergy to any of the study medications.

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Verified sites

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

Responsive
Complexo Hospitalario Universitario De Vigo
Vigo, Spain
Verified
Consorci Sanitari De Terrassa
Terrassa, Spain
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Sacituzumab
is a medication used in this trial as an adjuvant treatment for patients with non-small cell lung cancer (NSCLC). It is designed to help prevent the cancer from returning after surgery by targeting specific cancer cells and delivering a chemotherapy agent directly to them.
Zimberelimab
is another medication used in this trial alongside Sacituzumab. It is an immunotherapy drug that works by helping the body's immune system recognize and attack cancer cells more effectively. This can help improve the chances of keeping the cancer from coming back after surgery.

What is already known about the treatment

Sacituzumab
Sacituzumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating resectable non-small cell lung cancer. It is primarily indicated for patients who have undergone surgery but did not achieve a complete pathological response after initial treatment. Sacituzumab works by targeting specific proteins on cancer cells, delivering a toxic payload that helps to kill these cells. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug.
Zimberelimab
Zimberelimab is given through intravenous infusion and is under investigation in clinical trials for its potential use in treating resectable non-small cell lung cancer. It is intended for patients who have had surgery but did not achieve a complete pathological response after neoadjuvant therapy. Zimberelimab functions by blocking a protein that inhibits the immune system, thereby enhancing the body's ability to fight cancer cells. It belongs to the class of immune checkpoint inhibitors, which help to boost the immune response against cancer.

Investigated diseases

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. In its early stages, it may not cause noticeable symptoms, but as it progresses, it can lead to coughing, chest pain, and difficulty breathing. The progression of the disease can vary, with some tumors growing slowly and others spreading more rapidly.