Every cancer treatment approved for use today was first tested in a clinical trial with the help of people like yourself. We’re researching a potential cancer treatment for people with early-stage or locally advanced non-small cell lung cancer (NSCLC).
Participants in the Symbiotic-Lung-10 clinical trial will receive the study medicine either alone or in combination with chemotherapy. This clinical trial will help researchers understand how well the study medicine works when given alone or with standard chemotherapy to treat non-small cell 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.
This clinical trial has three parts. Each part has different requirements for who can join. You may be eligible to take part in this study if you are aged 18 or older and:
- For Part A: have been diagnosed with early-stage or locally advanced (Stage II or IIIA/B) NSCLC that can be removed with surgery
- For Part B: were diagnosed with early-stage or locally advanced (Stage II or IIIA/B) NSCLC and have already had surgery to remove it
- For Part C: have been diagnosed with locally advanced (Stage III) NSCLC that cannot be removed by surgery and have received/are receiving radiation and chemotherapy treatment
This is not a complete list of eligibility criteria for this clinical trial. The study doctor will review all eligibility criteria with you.
Condition
Non-small cell lung cancer
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 take part, you will receive the study medicine either alone or in combination with chemotherapy.
This clinical trial has three parts:
- Part A: Participants whose lung cancer can be removed with surgery will receive the study medicine along with standard chemotherapy, followed by surgery.
- Part B: Participants who have already had their tumor removed, will take the study medicine to see if it can help prevent the cancer from coming back.
- Part C: Participants whose cancer cannot be removed by surgery but is still localized to one area (locally advanced) will receive the study medicine after they finish their standard chemotherapy and radiation treatments.
The length of study treatment depends on which part of the study you are eligible to join, how your cancer responds to the study treatment, and your personal choice.
For participants in Part A, the treatment, surgery and post-operative period will last up to about 6 months. For participants in Parts B and C, the treatment period will last about 1 year. All participants will have follow-up visits or phone calls every 12 weeks until the study ends or you choose to stop taking part.
Length of study treatment
6 to 12 months
Long-term follow up
Phone calls or visits every 12 weeks
About the study medicine
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 NSCLC.
The study medicine will be given as an intravenous (IV) infusion, meaning directly into the bloodstream through a small tube inserted into a vein.
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 how a potential study medicine may work when combined with standard chemotherapy, 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. Your study doctor will discuss all the possible risks and benefits of participating with you if you qualify and 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
The Symbiotic-Lung-10 clinical trial will help researchers learn how well the study medicine works when given alone or with standard chemotherapy to treat non-small cell lung cancer. 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 reimbursed (paid back) 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.
