Adaptive Radiation + Pembrolizumab for Lung Cancer
Trial Summary
What is the purpose of this trial?
This phase I/II trial tests the safety and efficacy of split-course adaptive radiation therapy in combination with immunotherapy with or without chemotherapy for the treatment of patients with stage IV lung cancer or lung cancer that that has spread to nearby tissue or lymph nodes (locally advanced). Radiation therapy is a standard cancer treatment that uses high energy rays to kill cancer cells and shrink tumors. Split-course adaptive radiation therapy uses patient disease response to alter the intensity of the radiation therapy. Immunotherapy with monoclonal antibodies such as pembrolizumab, ipilimumab, cemiplimab, atezolizumab or nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs like carboplatin, pemetrexed, and paclitaxel work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving split-course adaptive radiation therapy with standard treatments like immunotherapy and chemotherapy may be more effective at treating stage IV or locally advanced lung cancer than giving them alone.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use immunosuppressive medications within 28 days of enrollment, except for certain corticosteroids, and you must not use any prohibited drugs within 30 days of enrollment.
What data supports the effectiveness of the treatment Adaptive Radiation + Pembrolizumab for Lung Cancer?
Research shows that combining pembrolizumab with chemotherapy, such as carboplatin and pemetrexed, is effective in treating advanced non-small cell lung cancer, improving survival rates and response to treatment. Additionally, studies indicate that adding pembrolizumab to carboplatin and paclitaxel/nab-paclitaxel enhances overall survival and progression-free survival in similar lung cancer cases.12345
Is the combination of adaptive radiation and pembrolizumab safe for lung cancer treatment?
Studies show that pembrolizumab combined with chemotherapy, like carboplatin and nab-paclitaxel, is generally safe for lung cancer patients, with some risk of side effects like pneumonitis (lung inflammation). The addition of pembrolizumab to these treatments has shown little impact on severe toxicity, but patients should be aware of potential immune-related side effects.13467
What makes the Adaptive Radiation + Pembrolizumab treatment for lung cancer unique?
This treatment combines pembrolizumab, an immune-boosting drug, with adaptive radiation therapy, which is tailored to the patient's specific needs, and chemotherapy drugs like carboplatin and nab-paclitaxel. This combination aims to enhance the body's immune response against cancer while precisely targeting tumors, potentially improving outcomes for patients with advanced lung cancer.89101112
Research Team
Evan Osmundson, MD
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Eligibility Criteria
Adults (18+) with stage IV lung cancer and limited metastases, who can handle the physical demands of the trial (ECOG 0-2). They must have tumor material for PD-L1 testing, managed brain metastases if present, and adequate organ function. Prior immunotherapy is allowed; however, they should not be pregnant or breastfeeding and must use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive a combination of chemotherapy, immunotherapy, and radiation therapy. Treatment cycles repeat every 3 weeks for up to 4 cycles, followed by maintenance therapy every 21 days for up to 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up visits occur at 4 weeks, 12 weeks, and then every 12 weeks for 2 years.
Treatment Details
Interventions
- Carboplatin
- Nab-paclitaxel
- Pembrolizumab
- Pemetrexed
- Radiation Therapy
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Varian Medical Systems
Industry Sponsor
Dow R. Wilson
Varian Medical Systems
Chief Executive Officer since 2012
MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University
Dr. Deepak Khuntia
Varian Medical Systems
Chief Medical Officer since 2020
MD from the University of Cambridge, PhD from the University of Leicester