A Phase 2 clinical trial is taking a closer look at how Black patients with advanced or metastatic non-small cell lung cancer (NSCLC) respond to immunotherapy, either alone or in combination with chemotherapy.
The study is designed specifically for Black patients with NSCLC, and researchers hope to enroll around 318 participants. The goal is to examine treatment outcomes and potential biomarkers that could help predict who is most likely to respond to treatment. The trial is currently recruiting participants at sites nationwide.
Keep reading to learn more about the trial and whether it’s right for you.
Why Are Researchers Seeking Black Patients Specifically?
NSCLC is the most common type of lung cancer, and Black Americans face significant disparities in lung cancer outcomes. Yet Black patients have historically been underrepresented in clinical research, which can make it harder for researchers to understand how treatments perform across different populations.
This study aims to generate data specifically on treatment response among Black patients. Researchers will look at real-world outcomes and predictive biomarkers, potentially providing a clearer picture of how Black patients respond to pembrolizumab-based treatment.
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How Does Immunotherapy Work?
Pembrolizumab is an FDA-approved immunotherapy called a checkpoint inhibitor. Unlike chemotherapy, which works directly on cancer cells, pembrolizumab helps the immune system recognize and attack cancer.
Cancer cells can be pretty good at hiding from the immune system. They can use certain proteins to essentially tell immune cells to back off. Pembrolizumab blocks that signal, giving the immune system a better chance to recognize and attack the cancer.
For people with advanced NSCLC, pembrolizumab can be given on its own or along with chemotherapy, depending on factors such as the characteristics of the cancer and the patient’s overall health. This trial evaluates both approaches. Like any cancer treatment, pembrolizumab and chemotherapy can cause side effects. Immunotherapy can sometimes cause the immune system to attack healthy organs, such as the lungs, intestines, liver, or thyroid. Participants should discuss risks with their care team.
Who Can Participate?
The trial is open to adults who self-identify as Black and have confirmed advanced or metastatic NSCLC. Participants must have an Eastern Cooperative Oncology Group Performance (ECOG) status of 0 to 2, meaning they have varying degrees of ability to carry out daily activities.
Participants must also be new to treatment for advanced, metastatic, or recurrent disease and must not have known EGFR, ALK, or ROS1 tumor mutations. Patients whose earlier-stage lung cancer returned at least six months after completing certain previous treatments may also be eligible.
The study team ultimately determines eligibility, and a qualifying diagnosis does not guarantee enrollment.
What Are the Benefits of Joining a Clinical Trial?
Clinical trials can offer more than access to treatments under study. They can also help researchers answer questions that may not be adequately addressed when research underrepresents racial and ethnic groups. Patients may also benefit from additional testing and a hands-on approach to addressing complex health concerns.
For Black patients with advanced lung cancer, the goal is to better understand which treatments work, for whom, and why. By studying treatment outcomes and biological markers specifically among Black patients, researchers hope to add evidence that could eventually help make cancer care more personalized.
The study is currently recruiting at multiple U.S. locations, including sites in Florida, Louisiana, Maryland, New York, North Carolina, and Tennessee. Anyone interested in participating should discuss the trial with their oncologist or contact the study team to determine whether they may qualify.
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Final Thoughts
For Black patients with non-small cell lung cancer, this trial represents more than an opportunity to test an existing treatment in a new group. The study could help fill a longstanding gap in lung cancer research, where Black patients have often been underrepresented in clinical trials, on top of exploring new treatment options. The findings may ultimately help researchers develop more personalized approaches to treating NSCLC and ensure that advances in immunotherapy benefit patients historically left out of research.