Immunotherapy + SBRT for Advanced Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining immunotherapy with precise radiation treatment is more effective than immunotherapy alone for advanced lung cancer. Specifically, it examines patient responses to pembrolizumab, an immunotherapy drug that aids the immune system in attacking cancer, either alone or with stereotactic body radiation therapy (SBRT), which targets tumors with high precision. Patients with stage IV non-small cell lung cancer who have already received some initial treatment might be suitable candidates, especially if they have a tumor that can be targeted by radiation. The trial seeks to improve treatment options for those facing this aggressive form of lung cancer. As a Phase 3 trial, it represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using stereotactic body radiation therapy (SBRT) with pembrolizumab is generally safe. One study found that this combination can be administered together if care is taken to protect normal tissue, suggesting manageable side effects.
For pembrolizumab alone, studies indicate it is well-tolerated by many patients with advanced non-small cell lung cancer (NSCLC) and is associated with longer survival compared to some other treatments.
Overall, past research has demonstrated that both treatment options in the trial are reasonably safe. Always consult a healthcare professional to understand what this means personally.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for advanced lung cancer because they offer a new approach to tackling the disease. Unlike traditional treatments such as chemotherapy and surgery, the combination of pembrolizumab with Stereotactic Body Radiation Therapy (SBRT) leverages the immune system to fight cancer more precisely. Pembrolizumab is an immunotherapy drug that stimulates the body's immune cells to target and attack cancer cells. When combined with SBRT, which delivers high doses of radiation to cancer cells with pinpoint accuracy, it potentially enhances the immune response and improves treatment outcomes. This innovative strategy could lead to more effective and less invasive treatment options for patients with advanced lung cancer.
What evidence suggests that this trial's treatments could be effective for advanced lung cancer?
Research shows that combining pembrolizumab with stereotactic body radiation therapy (SBRT) can enhance the immune response against tumors in non-small cell lung cancer. In this trial, one arm will receive this combination, which studies have found to better control cancer locally and potentially improve survival rates. SBRT precisely targets tumors, minimizing damage to normal tissue, while pembrolizumab aids the immune system in fighting cancer cells. Previous research has shown positive survival outcomes for patients treated with this combination in advanced lung cancer cases.
Another arm of this trial will receive pembrolizumab alone, which has already improved outcomes for patients with advanced non-small cell lung cancer, especially those with certain protein markers (PD-L1). The KEYNOTE-024 trial demonstrated that pembrolizumab significantly increased survival compared to traditional chemotherapy. Additionally, long-term data suggests that some patients continue to benefit from pembrolizumab over time. These findings provide strong evidence for the effectiveness of both pembrolizumab alone and in combination with SBRT in treating advanced lung cancer.23678Who Is on the Research Team?
Michael K. Farris
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for adults with stage IV non-small cell lung cancer that has spread and can be targeted by radiation. They must have had at least 4 cycles of systemic therapy without disease progression, be within 180 days from their first dose of this therapy, and have a performance status of 0-2. Pregnant women or those treated for other cancers (with some exceptions) in the last three years are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab IV every 3-4 weeks for 1 year, with or without stereotactic body radiation therapy (SBRT) consisting of 3-10 treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Stereotactic Body Radiation Therapy
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Cancer Institute (NCI)
Collaborator