Learn about a clinical trial for people with previously treated non-small cell lung cancer (NSCLC).

The Be6A LUNG-01 clinical trial is researching the safety and effectiveness of a study medicine compared to the current standard therapy (docetaxel chemotherapy) in people who have been previously treated for their advanced NSCLC. 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.

Who may participate

Deciding to take part in a clinical research study is an important and personal decision. Before you agree to take part, the study team will review all aspects of the clinical research study with you. You will be given a document called an Informed Consent Form 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 with your own doctor to decide if taking part is right for you.

You may be able to take part in the clinical trial if you:

  • Have a confirmed diagnosis of locally advanced, unresectable Stage IIIB, IIIC, or metastatic Stage IV nonsquamous* NSCLC
  • Have received prior treatment for your condition
  • Were informed your cancer returned or got worse after your most recent treatment

This is not a complete list of the study’s eligibility criteria, and the study doctor will review all the criteria with you. Thank you for considering the Be6A LUNG-01 study.

*Nonsquamous refers to a type of lung cancer determined by a pathologist.

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.

Get started — See if you may be eligible

Answer a 2-minute questionnaire.

A first step as you consider this study is to answer a 2-minute online questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.

Speak with a study representative.

If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your medical history to see if you may be able to participate and be referred to a study clinic that you select.

Confirm your eligibility.

Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.

 

What to expect

If you choose to participate and the study doctor determines the study is a good fit, you will be randomly assigned (like flipping a coin) to either the study medicine group (B6A) or the current standard therapy group (docetaxel). There is a 50/50 chance of getting assigned to either group. Your study doctor will know which group you are in. There is no placebo in this study.

It’s important to know that you may continue receiving the study medicine for up to 5 years. You or your study doctor may end your participation at any time if they feel the study isn’t helping you.

Additionally, you will get the following at no extra cost:

  • All study-related medical exams
  • Close monitoring of your cancer and overall health by doctors who specialize in lung cancer
  • Reimbursement (paid back) for some of your qualified travel and lodging costs for you or your caregiver, if applicable.

Length of study treatment

Up to 5 years

Number of study visits

Up to 2 visits per month after your first treatment cycle. Additional visits may be requested by your study doctor.

Why are we conducting the Be6A LUNG-01 study?

Each clinical trial has learning objectives. The main goals of this clinical trial are to understand:

  • whether life expectancy is extended
  • the percentage of patients who respond to the study medicine
  • whether there is an increase in the time that the cancer doesn’t spread
  • whether there are changes to/improvements in quality of life

This is not a complete list of the study’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 this study. Your participation is voluntary, and you are free to withdraw from the study at any time.

Why are we conducting the Be6A LUNG-01 study?

Woman and non-small cell lung cancer – Pfizer Clinical Trials
Woman and non-small cell lung cancer – Pfizer Clinical Trials

Frequently asked questions

Why is this clinical research study being conducted?
The clinical research study is trying to determine whether the study medicine compared with docetaxel can improve changes in health or quality of life.
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Who is conducting the clinical trial?
Pfizer is conducting the Be6A LUNG-01 clinical trial. We are dedicated to making sure that all patients are represented in our clinical trials. It is important that the therapies we make improve the lives of all people with cancer, including those who have been historically underrepresented due to their sex, race, ethnicity, or age.
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What does locally advanced, unresectable, and metastatic mean?

"Locally advanced” means the cancer has grown outside the body part where it started but has not yet spread to other parts of the body. “Unresectable” means the cancer cannot be removed by surgery. “Metastatic” means the cancer has spread to other parts of the body, such as the brain. People with any of the three types of NSCLC may be eligible to participate in this study.

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How does this study medicine work?

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 (into a vein) infusion twice every 28 days.

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Do I have to pay to take part?

All study-related medical care and the study medicine or docetaxel will be provided at no extra cost. You and your caregiver may be paid back for some of your travel and lodging costs.

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What is a study medicine?

A study medicine (sometimes called an investigational medicine or study drug) is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration [FDA], European Medicines Agency [EMA], or appropriate regulatory authorities in each country) for prescription use.

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Will my personal information be kept private?

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.

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Does my doctor need to give me permission to participate?

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 study.

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Can I withdraw from the Be6A-Lung clinical trial after I start?

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 study and decide to leave it, you should talk to your study doctor about leaving so that they can schedule a final evaluation.

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