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Study of Immunotherapy Combinations Including Zimberelimab for Patients With Advanced Non-Small Cell Lung Cancer

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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 treatments for Advanced Non-Small Cell Lung Cancer, a type of lung cancer that has spread to other parts of the body. The study will explore various combinations of immunotherapy, which is a treatment that helps the body's immune system fight cancer. The medications being tested include Zimberelimab (also known as AB122), Domvanalimab (AB154), and Quemliclustat (AB680). These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well these immunotherapy combinations work in treating the cancer and to assess their safety. Participants will receive the treatments over a period of time, and their response to the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study will also look at how the body processes these medications and any side effects that may occur.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the cancer. The study aims to provide valuable information on the effectiveness and safety of these new treatment combinations for people with advanced non-small cell lung cancer. The trial is expected to continue until March 2025, with recruitment starting in December 2023.

The research process

The trial runs in 6 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, a diagnosis of Stage IV metastatic non-small cell lung cancer is confirmed.
Eligibility is determined based on performance status, measurable lesions, and organ function.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health status.
This includes imaging tests and laboratory evaluations to measure target lesions and organ function.
Step 3
Treatment phase
The treatment phase involves receiving a combination of immunotherapy-based medications.
Medications such as cisplatin, pemetrexed, paclitaxel, docetaxel, carboplatin, zimberelimab, domvanalimab, quemliclustat, and paclitaxel albumin-bound are administered intravenously.
The specific combination and dosage depend on individual treatment plans.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and any side effects.
This includes periodic imaging and laboratory tests to evaluate the size of lesions and overall health.
Step 5
Completion of treatment
Upon completion of the treatment phase, a final assessment is conducted.
This includes evaluating the objective response rate and any adverse events experienced during the trial.
Step 6
Post-trial follow-up
After the trial, follow-up visits may be scheduled to monitor long-term health outcomes.
These visits help in understanding the overall survival and progression-free survival rates.

Who can join the trial?

7 criteria

Must have a confirmed diagnosis of Stage IV metastatic Non-Small Cell Lung Cancer (NSCLC). This means the cancer has spread to other parts of the body.
Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
Must have at least one measurable target lesion according to RECIST v1.1. This is a guideline used to measure how tumors respond to treatment.
Must have adequate organ and bone marrow function. This means the organs and bone marrow are working well enough to handle the treatment.
Must be willing to provide adequate tumor tissue. This means agreeing to give a sample of the tumor for study purposes.
Both male and female participants are eligible.
Participants from vulnerable populations are eligible. This means people who might need extra protection or care can also join.

Who cannot join the trial?

10 criteria

Patients with other types of cancer besides Advanced Non-Small Cell Lung Cancer cannot participate.
Patients who have not reached the required age range for the study cannot participate.
Patients who are not able to understand or follow the study procedures cannot participate.
Patients who have a medical condition that makes it unsafe for them to receive the study treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a severe allergic reaction to similar treatments in the past cannot participate.
Patients who have an active infection that requires treatment cannot participate.
Patients who have a history of certain heart conditions cannot participate.
Patients who have a history of certain lung conditions cannot participate.

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Verified sites

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

Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Centre Hospitalier Universitaire De Bordeaux
Verified
Bordeaux, France
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Immunotherapy-based Combination Therapy is a treatment approach used in this clinical trial for patients with advanced non-small cell lung cancer. This therapy involves using medications that help the body's immune system recognize and attack cancer cells more effectively. The goal is to improve the body's natural defenses to fight the cancer, potentially leading to better outcomes for patients. The trial aims to evaluate how well this combination therapy works in shrinking tumors and how safe it is for patients to use.

Zimberelimab

What is already known about the treatment

Immunotherapy-based Combination Therapy – This treatment is administered intravenously, meaning it is given through a vein, typically in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced non-small cell lung cancer. The main therapeutic indication is to improve the response rate in patients with this type of lung cancer. At the molecular level, the therapy works by stimulating the body's immune system to recognize and attack cancer cells more effectively. It falls under the pharmacological classification of immunotherapy, which involves using substances to enhance or restore the immune system's ability to fight cancer.

Investigated diseases

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its relatively slow growth compared to small cell lung cancer. It is called "non-small cell" because the cancer cells are larger than those of small cell lung cancer. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, bones, brain, and liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. The disease is often diagnosed at an advanced stage when it has already spread beyond the lungs.