NSCLC research is taking aim at chemotherapy

Now enrolling:

The TROPION-Lung08 study for adults with advanced or metastatic non-small cell lung cancer (NSCLC).

Ask your doctor if you are eligible for this study.

About the TROPION‑Lung08 study

This study is investigating DS-1062a to find out how well it works in combination with a standard therapy called pembrolizumab to slow tumor growth in patients with advanced or metastatic NSCLC.

Doctors will compare the study drug combination of DS-1062a and pembrolizumab to pembrolizumab alone. DS-1062a is an investigational drug, which is a drug that is not yet approved for use by the general public. Pembrolizumab is an approved drug used for the treatment of patients with advanced or metastatic NSCLC.

Who can participate in the TROPION-Lung08 study?

To be eligible for this study, you must be at least 18 years of age (or the age considered legal in your country) and :

  • Have been diagnosed with advanced or metastatic (Stage IIIB, IIIC, or IV) NSCLC
  • Have not received any previous anticancer full-body treatment (like chemotherapy) for advanced or metastatic NSCLC
  • Have a tumor biopsy prior to starting the study (it may be possible to use a recent tumor biopsy, if it meets certain criteria)

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you and answer any questions you may have about the study or costs for study-related activities.

What to expect

If you qualify, you will be involved with the study for about 2 and a half years.

Tissue Screening Period

These tests and assessments will help study doctors and study staff determine if you can participate in this study. The tissue screening period may occur at the same time as the screening period.

What you will need to do

  • Read and sign the informed consent forms
  • Review of your personal information
  • Review together with study staff the medications you are currently taking or have taken recently
  • Complete questionnaires regarding current symptoms

What we will do

  • Review of study eligibility

Other tests to check your eligibility to participate in the study

  • Pregnancy test (females of childbearing potential)
  • Tumor biopsy*
  • Blood and urine samples
  • Complete physical exam
  • Vital signs, height and weight measurements (temperature, blood pressure, pulse and breathing rate)
  • Electrocardiogram (ECG) (a test that measures the electrical activity of the heart)
  • Computed tomography (CT) and/or magnetic resonance imaging (MRI) (scans to measure location and size of tumors)
  • NSCLC-related history and assessments
  • Tumor sample specimen collection
  • Eye examination and blood oxygen level measurements
  • Hepatitis test
  • HIV test (as allowed by local regulations)

*These tests and procedures will occur during the tissue screening period. It may be possible to use a recent tumor biopsy, if it meets certain criteria.

Treatment Phase

These tests and assessments will help study doctors and study staff monitor your health while you are receiving the study drug as part of this study.

Your study drug will be administered in “cycles,” with each cycle lasting 21 days. You will be in this study for a minimum of one cycle and can continue for future cycles unless your disease gets worse, you and your doctor decide to stop, or you reach 35 cycles.

Before your scheduled study drug, you will be given certain premedications by your study doctor to take prior to each infusion. Premedications are medications that help to lessen the occurrence and severity of certain side effects associated with each of the study drugs.

Each cycle the following procedures will be done:

What you will need to do

  • Review of how you are feeling
  • Review together with study staff the medications you are currently taking or have taken recently
  • Once every 3 weeks, you will complete five patient questionnaires about your symptoms at home using an electronic device. One questionnaire will be completed once a week by you at home

What we will do

  • You will receive either standard treatment pembrolizumab (all infusions will occur over 30 minutes) followed by the investigational drug DS-1062a (first infusion will occur over 90 minutes), or pembrolizumab alone (all infusions will occur over 30 minutes) via intravenous (IV) infusion
  • Vital signs and weight measurements (temperature, blood pressure, pulse, and breathing rate)
  • Complete physical exam
  • Pregnancy test (females of childbearing potential)
  • Eye examination, if needed
  • Blood oxygen level measurements
  • Blood samples
  • Urine samples, if needed
  • ECG (a test that measures the electrical activity of the heart), if needed
  • ECHO (test showing the image and movements of your heart using ultrasound device), if needed
  • MUGA (test showing the image and movements of your heart using a small amount of radioactive tracer injected into your veins and detected by an external camera), if needed
  • CT and/or MRI scans to measure changes in location, number, and size of any tumors

Once every 3 weeks, you will complete five patient questionnaires about your symptoms at home using an electronic device. One questionnaire will be completed once a week by you at home.

Follow-up Period

Once you stop receiving the study drug, you will have an end of treatment visit immediately and a follow-up visit 30 days after the last dose of the study drug.

During these visits, the following procedures or measurements will be done:

What you will need to do

  • Review of how you are feeling
  • Review together with study staff the medications you are currently taking or have taken recently
  • Complete patient questionnaires about your symptoms

What we will do

  • Eye examination (end of treatment only)
  • ECHO or MUGA (end of treatment only)
  • ECG (end of treatment only)
  • Vital signs and weight measurements (temperature, blood pressure, pulse and breathing rate)
  • Complete physical exam
  • Blood oxygen level measurements
  • Blood samples
  • Urine samples, if needed
  • Pregnancy test (females of childbearing potential)
  • CT and/or MRI scans to measure changes in location, number, and size of any tumors

Once you have completed the follow-up visit

  • You will have visits or phone calls every 3 months to check on your progress
  • If your disease has not worsened, you will continue to have a CT and/or MRI performed to measure changes in location, number, and size of any tumors
  • Depending on follow-up visit results, you also may need to provide additional blood samples every 3 months up to 1 year after your last dose of DS-1062a

In this study, the following optional procedures may also be performed:

  • Due to the COVID-19 pandemic, with your consent and unless prohibited by local restrictions, an optional blood sample will be collected at Day 1 of Cycle 1, every four cycles, and at the end of treatment visit to test for antibodies to this virus. Antibodies are proteins that are produced by the immune system to help stop intruders (in this case, COVID-19) from harming the body.
  • In the event that you develop signs of inflammation of the lung known as interstitial lung disease (ILD), your study doctor may perform procedures to help manage your condition such as a lung biopsy or a bronchoalveolar lavage. With your consent, the biopsy tissue or the material obtained from the bronchoalveolar lavage will be available to the study team to better understand the safety of the investigational drug.

You may still continue to participate in this clinical study even if you choose not to participate in any optional tests or procedures.

What safeguards are in place to help protect study participants?

There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure studies follow strict scientific and ethical guidelines. Before a clinical research study can begin, a review board must review the study. This group is called an IRB or institutional review board, and is made up of doctors, scientists, and members of the community.

Is participation mandatory? Does it cost anything?

Taking part in this study is totally voluntary and you may stop at any time for any reason.

Additionally, there’s no cost for any study-related medication, care, tests, and exams.

Where can I learn more?

If you're interested in learning more about the TROPION-Lung08 study, including eligibility, potential risks and benefits of participation, you can find additional details at Leal Health.