NSCLC research is taking aim at chemotherapy

Now enrolling:

The TROPION-Lung07 study for adults with advanced or metastatic non-small cell lung cancer (NSCLC).

Ask your doctor if you are eligible for this study.

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About the TROPION‑Lung07 study

This study is investigating Dato-DXd (in combination with pembrolizumab, a standard therapy, with or without platinum-based chemotherapy) to find out how well it works to slow tumor growth in patients with advanced or metastatic NSCLC.

Doctors will compare the study drug combination of Dato-DXd plus pembrolizumab with or without platinum-based chemotherapy to pembrolizumab plus pemetrexed and platinum-based chemotherapy. Dato-DXd is a study 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-Lung07 study?

To be eligible for this study, you must:

  • Be at least 18 years of age (or the legal adult age in your country)
  • Have been diagnosed with advanced or metastatic (Stage IIIB, IIIC, or IV) NSCLC
  • Have not received any previous full-body anticancer treatment (like chemotherapy)

This is not a complete list of study requirements. The study doctor will review the full requirements with you.

What to expect

Participants will be in the study for approximately 36 months, which includes a safety follow-up period after the last dose of study drug.

Tissue Screening Period

These tests and assessments will help study doctors and study staff determine if you can participate in this study.

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

  • Vital signs measurement (temperature, blood pressure, pulse, and breathing rate)
  • Oxygen level measurement
  • Complete physical exam including height and weight measurement
  • Eye examination
  • Oral care plan instructions
  • Blood and urine samples
  • Pregnancy test (females of childbearing potential)
  • Hepatitis and HIV tests (as allowed by local regulations)
  • Electrocardiogram (ECG) (a test that measures the electrical activity of the heart)
  • Echocardiogram (ECHO) or a multigated acquisition (MUGA) scan (tests to measure how effectively your heart pumps blood)
  • Computed tomography (CT) and/or magnetic resonance imaging (MRI) (scans to measure location and size of tumors)
  • Tumor biopsy for lab tests*
  • Tumor biopsy for protein testing*
  • Administration of pemetrexed (only for some participants)

*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 don’t feel well, 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.

On Day 1 of each cycle, the following procedures will be done:

What you will need to do

  • Review of how you are feeling
  • Review of medications you are currently taking
  • Once every 3 weeks, you will use an electronic device to complete questionnaires about your symptoms at home. One questionnaire will be completed once a week. After Cycle 19, questionnaires will be completed every 6 weeks.

What we will do

  • Vital signs measurement (temperature, blood pressure, pulse, and breathing rate)
  • Oxygen level measurement
  • Complete physical exam including weight measurement
  • Eye examination
  • Oral care plan instructions
  • Blood and urine samples
  • Pregnancy test (females of childbearing potential)
  • COVID-19 test (at Cycle 1, Cycle 5, and then every 4 cycles, as allowed by local regulations and with your consent)
  • ECG (a test that measures the electrical activity of the heart)
  • ECHO or a MUGA scan (tests to measure how effectively your heart pumps blood) CT and/or MRI (scans to measure location and size of tumors)
  • Administration of Dato-DXd (only for some participants, depending on study group assignment)
  • Administration of pembrolizumab
  • Administration of pemetrexed (only for some participants, depending on study group assignment)
  • Administration of carboplatin or cisplatin (only for some participants, depending on study group assignment)

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.

What you will need to do

  • Review of how you are feeling
  • Complete questionnaires on the electronic questionnaire device
  • Review together with study staff the medications you are currently taking including nondrug therapies and radiotherapy

What we will do

  • Vital signs measurement (temperature, blood pressure, pulse, and breathing rate)
  • Oxygen level measurement
  • Complete physical exam including weight measurement
  • Eye examination (at End of Treatment visit only)
  • Oral care plan instructions
  • Blood and urine samples
  • Pregnancy test (females of childbearing potential)
  • COVID-19 test (at End of Treatment visit only, as allowed by local regulations and with your consent)
  • ECG (a test that measures the electrical activity of the heart; will occur at End of Treatment visit only)
  • ECHO or a MUGA scan (tests to measure how effectively your heart pumps blood; will occur at End of Treatment visit only)
  • CT and/or MRI (scans to measure location and size of 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 for up to 1 year after your last dose of study drug.

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

  • 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 study drug

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

Where can I learn more?

If you're interested in learning more about the TROPION-Lung07 study, including potential risks and benefits of participation, you can find additional details at CTGOV.

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