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Ongoing Trial: The ACHIEVE research study is comparing two treatment approaches for older adults with advanced non-small cell lung cancer

nurse or caregiver using stethoscope to examine senior man at home

Non-small cell lung cancer (NSCLC) is by far the most common type of lung cancer, making up about 80-85% of new cases in the United States each year. It mostly affects older adults, with the average age at diagnosis being around 70. Treatment depends on how advanced the cancer is and on results from tumor tests, which can show how well certain medicines might work.

About 4 out of 10 people with NSCLC that has spread (advanced) outside the chest or to other parts of the body are already managing other health conditions when diagnosed. These patients may be older, more frail, or have other health challenges, and are often left out of clinical trials. For example, they were not included in recent key studies of drugs that use the immune system to help the body fight cancer (immunotherapy). These studies have changed the treatment of advanced NSCLC and may be of great benefit to this group of patients.

Immunotherapy with a drug called pembrolizumab (pem-broh-LIH-zoo-mab) has become the standard first treatment, or part of the standard first treatment, for most patients with advanced NSCLC. Recent studies show that immunotherapy—either alone or combined with chemotherapy—leads to better results than chemotherapy alone. Studies show that immunotherapy by itself works best for patients whose tumors have high levels of the PD-L1 protein. PD-L1 is a biomarker—a substance doctors can measure in the tumor to help predict how well immunotherapy might work.

The ACHIEVE study, also known as EA5221, is a clinical trial for patients aged 70 and older with advanced NSCLC and with lower levels of PD-L1. Doctors are still determining which treatment works best for these patients—immunotherapy alone or immunotherapy and chemotherapy. This question is especially important for older adults.

Patients who take part in the study will be randomly assigned by a computer (randomized) to receive either pembrolizumab alone or pembrolizumab and chemotherapy. Their doctor will select a chemotherapy regimen that they believe is most appropriate for them.

At the start of the study, all patients will complete a brief questionnaire about their overall health. They will answer questions about their ability to carry out daily physical activities, such as walking, moving, and lifting. They will report on their everyday thinking, such as remembering, paying attention, and solving problems. They will also report on their nutrition and quality of life.

The results of this health assessment will be shared with the patient’s doctor to help guide treatment decisions. For example, the doctor may change the initial chemotherapy plan to another option, if needed. The health review will also help identify anyone in the trial who may be especially frail and at risk of developing additional health concerns during treatment. These patients may benefit from extra medical support to help relieve side effects, reduce distress, and maintain a good quality of life while receiving treatment.

The main goal of the study is to see which treatment approach helps patients live longer, also known as overall survival. The study will also look at how long the cancer stays under control, how well patients tolerate treatment, and any side effects they experience. It will compare how health assessments relate to treatment results, and how each treatment affects quality of life.

To be eligible for the study, patients must be 70 years of age or older and have NSCLC with lower levels of PD-L1. Their cancer must be at an advanced stage—meaning it has spread and is classified as stage 3B, 3C, or stage 4. Patients will not be eligible if they are candidates for targeted treatments (medicines designed to attack specific changes in cancer cells) or for combined chemotherapy and radiation. Patients must not have received prior treatment for advanced disease.

Learn more about ACHIEVE (EA5221) at ecog-acrin.org.

Non-small cell lung cancer (NSCLC) is by far the most common type of lung cancer, making up about 80-85% of new cases in the United States each year. It mostly affects older adults, with the average age at diagnosis being around 70. Treatment depends on how advanced the cancer is and on results from tumor tests, which can show how well certain medicines might work.

About 4 out of 10 people with NSCLC that has spread (advanced) outside the chest or to other parts of the body are already managing other health conditions when diagnosed. These patients may be older, more frail, or have other health challenges, and are often left out of clinical trials. For example, they were not included in recent key studies of drugs that use the immune system to help the body fight cancer (immunotherapy). These studies have changed the treatment of advanced NSCLC and may be of great benefit to this group of patients.

Immunotherapy with a drug called pembrolizumab (pem-broh-LIH-zoo-mab) has become the standard first treatment, or part of the standard first treatment, for most patients with advanced NSCLC. Recent studies show that immunotherapy—either alone or combined with chemotherapy—leads to better results than chemotherapy alone. Studies show that immunotherapy by itself works best for patients whose tumors have high levels of the PD-L1 protein. PD-L1 is a biomarker—a substance doctors can measure in the tumor to help predict how well immunotherapy might work.

The ACHIEVE study, also known as EA5221, is a clinical trial for patients aged 70 and older with advanced NSCLC and with lower levels of PD-L1. Doctors are still determining which treatment works best for these patients—immunotherapy alone or immunotherapy and chemotherapy. This question is especially important for older adults.

Patients who take part in the study will be randomly assigned by a computer (randomized) to receive either pembrolizumab alone or pembrolizumab and chemotherapy. Their doctor will select a chemotherapy regimen that they believe is most appropriate for them.

At the start of the study, all patients will complete a brief questionnaire about their overall health. They will answer questions about their ability to carry out daily physical activities, such as walking, moving, and lifting. They will report on their everyday thinking, such as remembering, paying attention, and solving problems. They will also report on their nutrition and quality of life.

The results of this health assessment will be shared with the patient’s doctor to help guide treatment decisions. For example, the doctor may change the initial chemotherapy plan to another option, if needed. The health review will also help identify anyone in the trial who may be especially frail and at risk of developing additional health concerns during treatment. These patients may benefit from extra medical support to help relieve side effects, reduce distress, and maintain a good quality of life while receiving treatment.

The main goal of the study is to see which treatment approach helps patients live longer, also known as overall survival. The study will also look at how long the cancer stays under control, how well patients tolerate treatment, and any side effects they experience. It will compare how health assessments relate to treatment results, and how each treatment affects quality of life.

To be eligible for the study, patients must be 70 years of age or older and have NSCLC with lower levels of PD-L1. Their cancer must be at an advanced stage—meaning it has spread and is classified as stage 3B, 3C, or stage 4. Patients will not be eligible if they are candidates for targeted treatments (medicines designed to attack specific changes in cancer cells) or for combined chemotherapy and radiation. Patients must not have received prior treatment for advanced disease.

Learn more about ACHIEVE (EA5221) at ecog-acrin.org.

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