Not recruiting

Study of BAT3306 or pembrolizumab with chemotherapy (carboplatin and pemetrexed) in patients with stage IV non-squamous non-small cell lung cancer

Registered drugNo placebo

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What is this trial about?

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

This study focuses on patients with Stage IV Non-squamous Non-small Cell Lung Cancer. The research compares two treatment approaches: a new medication called BAT3306 combined with chemotherapy, and Keytruda (also known as pembrolizumab) combined with chemotherapy. The chemotherapy medications used in both groups are pemetrexed and carboplatin, which are given through intravenous infusion.

The main purpose of this study is to compare how similar these treatments are in terms of how the body processes them and how effective they are in treating lung cancer. The study will measure how well tumors respond to treatment and track the levels of medication in patients' blood. This is a double-blind study, which means neither the patients nor their doctors will know which treatment they are receiving.

During the study, patients will receive treatment for up to 24 months. The medications will be given through an intravenous line (a small tube inserted into a vein). Throughout the study, patients will have regular check-ups to monitor their health, including blood tests, physical examinations, and scans to check how their cancer is responding to treatment. The study will also track any side effects that patients may experience during treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive treatment through intravenous infusion that combines multiple medications: pembrolizumab (Keytruda), pemetrexed, and carboplatin.
Treatment is administered to address stage IV non-squamous non-small cell lung cancer.
Your doctor will perform regular assessments of your tumor response using specialized imaging techniques.
Step 2
Monitoring and evaluation
Regular health checks will include vital signs, physical examinations, heart monitoring (ECG), and laboratory tests.
Your doctor will monitor for any side effects or adverse reactions to the treatment.
Blood samples will be taken to measure drug levels in your body.
Imaging scans will be performed to track changes in tumor size and response to treatment.
Step 3
Long-term follow-up
Your progress will be monitored throughout the study period, which may continue until December 2028.
Regular assessments will track how long your response to treatment lasts.
Your survival and disease progression will be monitored over time.
Additional blood tests will check for antibodies your body may develop to the treatment.
Step 4
Safety requirements
You must use appropriate contraception during treatment and for 120 days after the last dose of pembrolizumab.
Contraception must continue for 180 days after the last dose of chemotherapy medications.
Regular pregnancy tests are required for female participants who can become pregnant.
You must follow current health guidelines regarding COVID-19 exposure throughout the study period.

Who can join the trial?

17 criteria

Must be at least 18 years old
Must have adequate organ function, including:
- Sufficient bone marrow function (specific blood cell counts)
- Proper liver function
- Good kidney function
- Normal blood clotting
- Female participants who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
- Both male and female participants must use effective birth control during the study and for:
  - 120 days after the last dose of main study medicine
  - 180 days after the last dose of chemotherapy
  - Must agree to follow COVID-19 safety guidelines throughout the study
  - Must be able to provide informed consent and willing to follow study procedures
  - Must have a life expectancy of at least 3 months
  - Must have good physical functioning ability (ECOG status 0-1, meaning able to perform daily activities)
  - Must have confirmed Stage IV non-squamous non-small cell lung cancer
  - Must not have certain genetic changes in the tumor (EGFR, ROS1, or ALK)
  - Must not have received previous treatment for advanced lung cancer
  - Must provide a tumor tissue sample for testing
  - Must have measurable cancer that can be monitored during the study

Who cannot join the trial?

14 criteria

Previous treatment with any anti-PD-1/PD-L1 therapy (drugs that affect immune system response)
Active or untreated brain metastases (cancer that has spread to the brain)
History of autoimmune disease (condition where immune system attacks healthy cells)
Active infection requiring systemic treatment (infection needing medication that affects entire body)
Uncontrolled high blood pressure or heart disease
Pregnant or breastfeeding women
Known allergy or sensitivity to study medications
Major surgery within 4 weeks before starting the study
Participation in another clinical trial within 30 days
Active hepatitis B or C infection (liver infections)
Unstable medical conditions that could interfere with study participation
History of other cancers within the past 5 years (except successfully treated skin cancer or early-stage cancer)
Inability to swallow oral medications
Severe kidney or liver problems

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Investigated drugs

BAT3306
is an investigational medication being studied as a potential biosimilar to Keytruda. It is being tested in combination with chemotherapy for treating non-small cell lung cancer.
Keytruda
(pembrolizumab) is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein called PD-1, which allows the body's T-cells to detect and attack cancer cells more effectively.
Chemotherapy
refers to cancer-fighting drugs that work by killing rapidly dividing cells throughout the body. In this trial, it is used in combination with either BAT3306 or Keytruda to treat lung cancer.

What is already known about the treatment

BAT3306
An investigational immunotherapy medication being studied for the treatment of advanced non-small cell lung cancer (NSCLC), administered through intravenous infusion. This drug is currently undergoing Phase I/III clinical trials to evaluate its effectiveness compared to Keytruda when combined with chemotherapy. It is designed to work as an immunotherapy agent, likely targeting specific immune checkpoints to enhance the body's natural ability to fight cancer cells.
Keytruda
(pembrolizumab) - A well-established immunotherapy medication administered through intravenous infusion, approved for treating various types of cancer, including non-small cell lung cancer. It belongs to the class of PD-1 inhibitors that work by blocking certain proteins on immune cells, helping the immune system recognize and attack cancer cells more effectively. The medication has demonstrated significant efficacy in treating advanced NSCLC, particularly when combined with chemotherapy as a first-line treatment.

Investigated diseases

Non-squamous Non-small Cell Lung Cancer (Stage IV) - A type of lung cancer that begins in the larger lung cells and specifically excludes squamous cell types. In stage IV, the cancer has spread beyond the lungs to other parts of the body, such as the liver, bones, or brain. The disease develops when cells in the lungs begin to grow uncontrollably, forming tumors that can interfere with normal lung function. Non-squamous NSCLC includes several subtypes, with adenocarcinoma being the most common form. The condition typically affects the outer regions of the lungs and can spread through the bloodstream or lymphatic system to other organs.