Actively Recruiting
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
Led by Vanderbilt-Ingram Cancer Center · Updated on 2024-10-17
25
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Histologically or cytologically confirmed stage IVA or IVB (M1b or M1c) or locally advanced non-small cell lung cancer not eligible for standard chemoradiation
- Tumor material less than 6 months old available for PD-L1 testing
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Adequate organ function to receive therapy
- Brain metastases allowed if managed with surgery and/or stereotactic radiosurgery before chemo-immunotherapy
- Use of contraception as directed for approved chemotherapies
- Female patients must be non-pregnant and not breastfeeding; women of childbearing potential must use highly effective contraception and have a negative pregnancy test within 1 week before therapy
- Eligible for immunotherapy-based systemic regimens per study physician
- Able to give written informed consent
You will not qualify if you...
- Mixed small cell histology
- Candidate for alternative systemic therapy preferred by treating physician (e.g., mEGFR, ALK, KRAS G12C, or ROS1 mutations)
- Brain metastases requiring whole brain radiotherapy within 21 days before study treatment
- Symptomatic malignant ascites or malignant pleural effusion
- Major surgery within 4 weeks before enrollment preventing study treatment
- History of organ transplant requiring immunosuppression
- Active or significant acute or chronic infections including HIV, hepatitis B or C, or active tuberculosis
- Uncontrolled illnesses such as severe heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmia, active peptic ulcer, bleeding disorders, or psychiatric illness limiting participation
- COPD exacerbation or respiratory illness requiring hospitalization within 30 days before study treatment
- Prior independent malignancy within 3 years except certain treated skin or in situ cancers
- More than one prior cycle of immune checkpoint inhibitor for current cancer
- Prior radiotherapy preventing protocol-based radiotherapy per study physician
- Use of immunosuppressive medications within 28 days before enrollment except specified corticosteroids
- Active autoimmune disease needing systemic treatment within past year
- Receipt of live attenuated vaccine within 30 days before enrollment
- Use of prohibited drugs within 30 days before enrollment
- Severe hypersensitivity to study interventions
- Concurrent enrollment in another clinical trial unless observational or in follow-up
- Any condition that would prevent participation per investigator discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Service for Timely Access
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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