Investigational Individualized Neoantigen Therapy Clinical Trials for Certain People with Lung Cancer – BlackDoctor

Sponsored by Merck

What is non-small cell lung cancer?

Lung cancer happens when normal cells in your lungs change and grow out of control.¹ The most common type of lung cancer is non-small cell lung cancer (NSCLC).² About 8 in 10 of all lung cancers are NSCLC.² 

When NSCLC is caught early, before it spreads to other parts of the body, the first treatment is usually surgery to remove the cancer.³ However, the cancer can come back after surgery.³ 

Lung cancer in Black communities

Black Americans can face a higher burden of lung cancer and greater obstacles to cancer prevention, detection, treatment and survival.^4,5 Compared to white U.S adults, Black U.S. adults are more likely to be diagnosed with lung cancer at later stages, when the cancer has spread to other parts of the body, and may have less access to treatments.⁴ 

We need representation in clinical trials 

Clinical trials help researchers learn how our bodies respond to medicines, vaccines or other treatments. Before investigational medicines, treatments and medical devices can be approved for public use, they must first be studied in clinical trials. Treatments don’t always work the same in everyone, so we need clinical trials to include people from various communities. Yet many groups are not equally represented in clinical trials.⁶ For example, Black Americans only represent 8% of clinical trial participants, despite making up approximately 13% of the U.S. population.^7,8

“When people from communities that are most affected by a disease like lung cancer are included in clinical trials, researchers are able to better understand how investigational drugs work for them,” said Michelle Chawla, Clinical Trial Representation Program Lead at Merck. “Representation in clinical trials helps support the development of safe and effective medicines for those who are most affected by the disease or condition.”

Investigational individualized neoantigen therapy clinical trials for certain people with NSCLC

Cancer is a result of the body’s own cells undergoing mutations which create abnormal proteins in cancer cells, known as neoantigens, that are not usually seen in normal cells.⁹ These mutations can be specific to each person’s tumor.⁹ 

Merck is sponsoring three Phase 3 clinical trials for certain adults aged 18 and older with NSCLC at multiple U.S. locations. The trials are studying an investigational therapy called individualized neoantigen therapy which is a type of investigational cancer therapy designed to be personalized for each person. Researchers are studying whether this investigational therapy has the potential to help a person’s immune system recognize these abnormal proteins (neoantigens) and provide the body’s immune system with the instructions needed to target the cancer cells.

• NCT06077760: This clinical trial is for adults who have Stage II, IIIA or IIIB (N2) NSCLC, had surgery to remove cancer then at least one dose of chemotherapy, have not had radiation therapy or certain other cancer treatments for NSCLC and have no signs of cancer when they join the trial. Learn more about this clinical trial. 
• NCT06623422: This clinical trial is for adults who have Stage II, IIIA, or IIIB (N2) NSCLC, can have surgery to remove the cancer and have not had other treatment for NSCLC. Learn more about this clinical trial.
• NCT07513376: This clinical trial is for adults who have Stage I NSCLC with certain high-risk features, have had surgery to completely remove the cancer and have not had other treatment for NSCLC. Learn more about this clinical trial. 

There are additional criteria which the study staff will discuss with you that will determine whether you are eligible to participate in this trial.

Here are some other things to know about this trial:

• Taking part in this clinical trial is voluntary.
• Participants can leave the trial at any time, for any reason.  
• Participants may or may not directly benefit from the trial, as the investigational therapy they get may or may not work for them. 

The trial staff will discuss the possible risks and benefits of participation with participants, and participants can ask questions before agreeing to participate.

Learn more

For more information, talk to your doctor or learn more about the three clinical trials by visiting merckclinicaltrials.com/NSCLCtrials.

 References

1. World Health Organization. Lung cancer. Updated April 16, 2026. Accessed August 2026. https://www.who.int/news-room/fact-sheets/detail/lung-cancer 
2. Cleveland Clinic. Non-small cell lung cancer. Updated January 16, 2025. Accessed August 2026. https://my.clevelandclinic.org/health/diseases/6203-non-small-cell-lung-cancer 
3. American Cancer Society. Treatment Choices for Non-small Cell Lung Cancer, by Stage. Updated August 1, 2024. Accessed August 2026. https://www.cancer.org/cancer/types/lung-cancer/treating-non-small-cell/by-stage.html 
4. American Lung Association. Racial and ethnic disparities. Updated February 5, 2026. Accessed August 2026. https://www.lung.org/research/state-of-lung-cancer/racial-and-ethnic-disparities
5. American Cancer Society. Cancer disparities in the Black community. American Cancer Society. Accessed August 2026. https://www.cancer.org/about-us/what-we-do/health-equity/cancer-disparities-in-the-black-community.html 
6. Peters U, Turner B, Alvarez D, et al. Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials. Ther Innov Regul Sci. 2023;57(2):186-195. doi:10.1007/s43441-022-00464-3
7. US Census Bureau. QuickFacts: United States. Accessed August 2026. https://www.census.gov/quickfacts/fact/table/US.4 
8. Cavazzoni P, Anagnostiadis E, Lolic M. 2020 Drug Trials Snapshots Summary Report. US Food and Drug Administration; 2021:3. Accessed August 2026. https://www.fda.gov/media/145718/download 
9. Merck. What are individualized neoantigen therapies? Published May 20, 2026. Accessed August 2026. https://www.merck.com/stories/individualized-neoantigen-therapies/