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Ongoing Trial: The INSIGNA clinical trial is testing the timing of immunotherapy alone or with chemotherapy for patients with advanced lung cancer

Lung x-ray on iPad

The Food and Drug Administration (FDA) has approved several drug combinations to treat patients with non-small cell lung cancer—the most common type of lung cancer. Many of these treatments are the result of medical discoveries about signals in cancer cells, called biomarkers, that often drive tumor growth and spread. Now, doctors can match many patients to treatments that target exact biomarkers and prevent them from helping cancer grow.

The INSIGNA research study (EA5163 and S1709) is for the initial treatment of adults with stage 4 (advanced, metastatic) non-small cell lung cancer whose tumors have the biomarker PD-L1. In cancer tumors, PD-L1 subdues the body’s immune system. Prior research found better survival when this group of patients received immunotherapy drugs that may help the body’s immune system attack cancer and may interfere with the ability of tumor cells to grow and spread.

INSIGNA aims to improve the treatment options for patients with advanced, non-squamous, non-small cell lung cancer with the PD-L1 biomarker. The usual approach for these patients is to start treatment (also known as first-line therapy) with a combination of chemotherapy and immunotherapy. However, if the amount of PD-L1 in the patient’s cancer cells is high (greater or equal to 50%), the doctor may consider treatment with immunotherapy alone.

With multiple first-line options available for patients, the INSIGNA trial seeks to find out whether patients with the PD-L1 biomarker can either delay having chemotherapy or avoid it altogether. Starting with immunotherapy alone may result in fewer side effects. The drug being tested is pembrolizumab (pem-broh-LIH-zoo-mab).

The INSIGNA trial is exploring two important questions:

  • Does starting treatment with pembrolizumab alone, instead of a combination of immunotherapy and chemotherapy, improve survival?
  • Will survival improve by adding chemotherapy for those patients with cancer that got worse after their initial course of immunotherapy alone?

About 846 patients will take part in the study. They will be randomly assigned by a computer to one of three treatment groups, with approximately 282 patients in each group:

  • Group 1: Patients in this group will start treatment with pembrolizumab. They may continue on this drug for up to 2 years. If the cancer gets worse, they will receive chemotherapy as second-line treatment.
  • Group 2: Patients will also begin treatment with pembrolizumab for up to 2 years. If the disease gets worse, they will receive both chemotherapy and pembrolizumab as second-line treatment.
  • Group 3: This is the usual approach arm of the trial. Patients in this group start treatment with both chemotherapy and pembrolizumab for up to 2 years. If this approach stops working, their doctor will recommend another therapy.

For all treatment groups, patients will have imaging (CT, MRI, and/or PET scan) to see how the cancer is responding to the therapy before they begin treatment. Then, they will have imaging again every 6, 9, or 12 weeks of treatment.

INSIGNA is a collaboration among researchers with the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and the SWOG Cancer Research Network (SWOG). The ECOG-ACRIN study chair is Hossein Borghaei, DO, MS, of Fox Chase Cancer Center. The SWOG Study Chair is Anne Chiang, MD, PhD, of Yale Cancer Center.

Learn more about EA5163/INSIGNA at

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