NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Learn about a clinical trial for non-small cell lung cancer (NSCLC)
The Be6A LUNG-02 Clinical Trial is evaluating the safety and effectiveness of a study medicine (sigvotatug vedotin) used with a standard therapy (pembrolizumab) in people who have not yet been treated for advanced non-small cell lung cancer (NSCLC).
Deciding to take part in a clinical trial is an important and personal decision. Before you agree to take part, the study team will review all aspects of the clinical trial with you. You will be given a document called an Informed Consent Document (ICD) that provides, in writing, details about the clinical trial including benefits and risks. You will have the opportunity to ask questions and are encouraged to speak to your own doctor to decide if taking part is right for you.
You may be eligible to take part in the clinical trial if you:
This is not a complete list of the eligibility criteria for this clinical trial. The study doctor will review all the criteria with you.
Condition
Advanced 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.
In the clinical trial, the combination therapy (the study medicine + the standard therapy) will be compared to using the standard therapy alone. You will have a 1 in 2 (50%) chance of receiving the combination therapy or the standard therapy alone.
Additionally, you will get the following at no extra cost:
Your participation may help increase medical knowledge about non-small cell lung cancer for the future.
Length of study treatment
Up to 5 years
Number of study visits
5 visits in the first cycle, and up to 3 visits for all other cycles
Long-term follow up
Every 6 weeks for the first year and every 3 months afterwards
The main goals of this clinical trial are to understand:
This is not a complete list of the clinical trial’s goals. The study doctor can review the complete list with you.
Your safety while participating is our highest priority. If you have questions or concerns at any point throughout the clinical trial, a study team member is available. Your privacy will be maintained throughout the clinical trial. Your participation is voluntary, and you are free to withdraw from the clinical trial at any time. Your study doctor may end your participation if they feel the clinical trial isn’t in your best interest.
The study medicine is designed to stick to cancer cells and kill them by delivering an anticancer treatment.
The study medicine may also attach to non-cancer cells. The study medicine is given by intravenous (through a vein) infusion in a cycle that repeats every 6 weeks. Infusions of the study medicine are given 3 times per cycle (Day 1, Week 2, and Week 4). The standard therapy is given by intravenous infusion 1 time (Day 1) during every 6-week cycle.
Deciding to take part in a clinical trial is an important and personal decision. Before you agree to take part, the study team will review all aspects of the clinical trial with you. You will be given a document called an Informed Consent Document (ICD) that provides, in writing, the clinical trial’s purpose, assessments, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and are encouraged to speak with your own doctor to decide if taking part is right for you.
All study-related medical care and the standard therapy and/or the study medicine will be provided at no extra cost. You and your caregiver may also be paid back for some qualified travel and lodging costs, if applicable.
No, there is no placebo in this clinical trial. All participants will receive the standard therapy (pembrolizumab). Some participants will also get the study medicine (sigvotatug vedotin).
A study medicine is a medication that has not been approved by regulatory or health authorities (eg, United States Food and Drug Administration [US FDA], European Medicines Agency [EMA], or appropriate regulatory authorities in each country) for prescription use.
The study medicine is designed to stick to cancer cells and kill them by delivering an anticancer treatment. The study medicine may also attach to non-cancer cells.
Yes, the information you provide will not be shared with anyone who is not directly associated with this clinical trial without your permission, except as required by law or as set forth in the informed consent.
No, your doctor does not have to give you permission to take part. However, feel free to talk to your doctor about participating. With your permission, the study doctor will keep your regular doctor updated about your condition during the clinical trial.
Yes, taking part in any clinical trial is completely voluntary. If you decide to take part, you are free to withdraw at any time, for any reason, and without any penalty or effect on your future medical care. If you are in the clinical trial and decide to leave it, you should talk to your study doctor about leaving so that they can end your participation in the safest way.
Clinical trials (or research studies) are a type of medical research in which people volunteer to take part. Clinical trials commonly study how potential medicines and other medical treatments affect the participants.
All medicines and vaccines that become available today for use in patients are first tested in clinical trials involving hundreds to thousands of people.
As part of a clinical trial, your study-related medical care is provided by the study team at the location where you’re participating. This includes the principal investigator (or study doctor) — the healthcare professional who conducts and takes responsibility for the trial at that location — as well as other clinical study team members. To help make sure that a clinical trial is ethical, and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review study protocols.
We encourage everybody to consider joining clinical trials. There are many types of clinical trials that study different aspects of health in people with a variety of backgrounds and conditions. Each clinical trial has its own criteria for who may participate. These are called eligibility criteria.
Eligibility criteria include things like your age, sex, overall health, type of condition, and your medical treatment history. As part of the steps to join a clinical trial, the study doctor will confirm whether you meet all eligibility criteria and are able to participate.
Participation in a clinical trial is always voluntary. The decision to join is personal, and it is yours.
