We’re researching a potential treatment for advanced non-small cell lung cancer (NSCLC) to see if it may work better than a current standard treatment.
Participants in this clinical trial will receive either a study medicine combined with chemotherapy, or pembrolizumab (an approved medicine) combined with chemotherapy. This clinical trial will help researchers learn if the study medicine combination works better than the pembrolizumab combination to treat lung cancer.
If you choose to take part in this clinical trial, you could help us continue to make progress in NSCLC research.
Who may participate
Joining a clinical trial is an important and personal decision.
You may be eligible to take part in this clinical trial if you are:
- 18 years or older
- Have been diagnosed with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) squamous or non-squamous NSCLC
- Your cancer cannot be removed (resected) by surgery or treated with chemoradiotherapy
- You have not previously received an anti-tumor therapy to treat your type of cancer
This is not a complete list of the eligibility criteria for this clinical trial. The study doctor will review all eligibility criteria with you.
Condition
Non-small cell lung cancer (NSCLC)
Age
18+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you decide to participate, you will receive either the study medicine or pembrolizumab (an approved medicine), in combination with chemotherapy.
You will have a 50% (1 in 2) chance of receiving the study medicine and a 50% chance of receiving pembrolizumab. All participants will also receive chemotherapy decided by the study doctor based on their type of NSCLC (squamous or non-squamous).
You will receive the study treatment for approximately 2 years, or until your cancer worsens or until you or the study doctor decides you should stop the study treatment. You will have regular study visits while receiving the study treatment.
All participants will have an in-person follow-up visit or phone call every 12 weeks after the end-of-treatment visit, until the study ends.
Length of study treatment
Approximately 2 years
Follow-up
In-person visit or phone call every 12 weeks after the end-of-treatment visit
About the study treatments
The study medicine is a bispecific antibody designed to target two different proteins, PD-1 and VEGF, at the same time. These proteins can play a role in how the cancer grows and how the immune system responds to it. It is thought that by binding (or connecting) to these two proteins, the study medicine may help the immune system find and attack the cancer cells while also potentially slowing down tumor growth, which may be more effective for treating lung cancer than targeting PD-1 alone.
Pembrolizumab combined with chemotherapy is a standard treatment for NSCLC. Pembrolizumab binds to PD-1 on the surface of the cancer cells and helps your immune system to recognize and attack them.
Potential risks and benefits of taking part in the clinical trial
People who take part in clinical studies are key to advancing medical research. By taking part in this clinical trial, you will be helping to advance research which may help yourself and others with NSCLC in the future.
This clinical trial offers the opportunity to explore if the potential study medicine combination may work better than an approved standard treatment for people with NSCLC.
Participant safety is the top priority of this clinical trial. It is possible your condition or health may improve, worsen, or stay the same. The study doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll.
In addition:
- The study team will monitor your health closely during the clinical trial
- The study treatment and any study-related procedures will be provided at no cost
- Travel support may also be available
- You will help advance research for the future of NSCLC treatments
Frequently asked questions
This clinical trial is evaluating a potential treatment to see if it may work better than a standard treatment (pembrolizumab combined with chemotherapy) to treat non-small cell lung cancer (NSCLC). Despite recent advancements in treatment options, the prognosis for patients with NSCLC is very challenging. There is an urgent need to develop potential new therapies.
The study treatment and any study-related procedures are generally covered at no cost. You may be paid back (reimbursed) for reasonable expenses that you and your caregiver have as a result of taking part in this study. This may include parking, meals, or other travel-related expenses. Please speak with the study doctor if you have any questions about costs resulting from being in this study.
This is a double-blind clinical trial, which means that you and the study team will not know whether you are receiving the study medicine or pembrolizumab. You will receive chemotherapy in combination with the study medicine or pembrolizumab. You will have a 50% (1 in 2) chance of receiving the study medicine and a 50% chance of receiving pembrolizumab.
Most study visits are expected to last approximately 6 to 8 hours. These visits will consist of different types of tests, procedures, and assessments.
As part of this study, we will analyze your blood samples and a small portion of your tissue sample to examine various biological indicators known as biomarkers. These biomarkers will help us understand how the study drug interacts with your body and what factors may influence its effectiveness. By studying these markers, we aim to identify which patients are most likely to benefit from this treatment in the future
