Split-Course Adaptive Radiation Therapy with Pembrolizumab for Stage IV Lung Cancer
This study is testing a new way to treat stage IV lung cancer or locally advanced lung cancer that cannot be treated with standard methods. Researchers are looking at the safety and effectiveness of a special type of radiation therapy called split-course adaptive radiation therapy. This radiation therapy adjusts based on how your disease responds. It's given along with pembrolizumab (an immunotherapy drug) and may also include chemotherapy drugs like carboplatin and nab-paclitaxel. The study aims to see how many patients respond to the treatment within six months and to track any side effects for up to two years. You may be able to join if you are at least 18 years old and have stage IVA or IVB non-small cell lung cancer. The study plans to enroll 25 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 25 participants. It is testing a combination of radiation therapy, immunotherapy, and potentially chemotherapy.
- What's involved
- Participants will undergo procedures like biospecimen collection and PET/CT scans. They will receive fludeoxyglucose F-18 (a radioactive tracer) and study medications.
- Compensation
- Not stated in the trial record.
- Follow-up
- The incidence of adverse events will be measured for up to two years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05501665
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentVanderbilt-Ingram Cancer CenterInvestigator-initiated
~25 participants
Updated 2024-10-17 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCarboplatinComputed TomographyFludeoxyglucose F-18Nab-paclitaxelPembrolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 2 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Evan Osmundson, MD, PhD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>= 18 years at time of informed consent
• Histologically documented or cytologically confirmed diagnosis of stage IVA or IVB (M1b or M1c) or locally advanced (not eligible for standard of care \[SOC\] chemoradiation) non-small cell lung cancer with evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria
Available tumor material (\< 6 months old) adequate for confirmation of programmed cell death 1 ligand 1 (PD-L1) expression per local standard of care testing
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate organ function to receive therapy as determined by investigators and other treating physicians
Participants with brain metastases that can be comprehensively managed with surgery and/or stereotactic radiosurgery, prior to initiation of chemo-immunotherapy are allowed. Number of brain metastases allowed is not specified at eligibility is at discretion of investigator
Contraceptive use should be initiated or continued per guidance in labeling for approved chemotherapies
Female patients must be non-pregnant and not breastfeeding.
If woman of childbearing potential (WOCBP), must utilize highly effective contraceptive method (failure rate of \< 1% per year) throughout intervention period and continued per guidance specified in labeling for approved chemotherapies. Must have negative pregnancy test (serum or urine) within 1 week prior to initiation of first cycle of therapy
Eligible for immunotherapy-based systemic regimens per judgment of patient's study physician
Able to submit written informed consent
Exclusion
Mixed small cell histology
Confirmed candidate (per study physician) for alternative systemic therapy if preferred by treating physician (i.e. mEGFR, ALK, KRAS G12C or ROS1 mutations). Testing not required for enrollment
Brain metastases that would require administration of whole brain radiotherapy for management on required screening brain MRI within 21 days of day 1 of study treatment
Symptomatic malignant ascites or malignant pleural effusion (sampling not required). Pleural metastases are allowed if deemed targetable with radiotherapy
Major surgery (requiring general anesthesia or at discretion of study physician) within 4 weeks prior to study enrollment that would prevent treatment with SiCARIO regimen
History of organ transplant requiring therapeutic immunosuppression
Known clinically significant (per study physician) acute or chronic infections including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or active tuberculosis (testing not required). Patients with HBV and HCV must be on stable dose of antiviral therapy on study entry
Uncontrolled intercurrent illness including, but not limited to, New York Heart Association (NYHA) class III-IV congestive heart failure, uncontrolled hypertension (average systolic blood pressure greater than or equal to 140 or average diastolic blood pressure greater than or equal to 90 despite optimal medical therapy), unstable angina pectoris, cardiac arrythmia, active peptic ulcer disease, bleeding diatheses or psychiatric illness that would limit in the judgment of the study physician
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of day 1 of study treatment
History of prior independent malignancy within 3 years of enrollment, except for adequately treated basal or squamous cell carcinoma of the skin, adequately treated carcinoma in situ (e.g. cervix or non-invasive bladder cancer)
Receipt of prior \>1 cycle of immune checkpoint inhibitor for current malignancy (prior cytotoxic chemotherapy is allowed)
Prior radiotherapy that would preclude delivery of protocol- based radiotherapy to normal organ tolerance per patient's study physician
Current or prior use of immunosuppressive medications within 28 days of enrollment with exception of intranasal or inhaled corticosteroids or systemic steroids at physiologic doses (equivalent to less than or equal to 10 mg/day of prednisone). Systemic steroids required during therapy for adverse event (AE) management and for residual neurologic complications from management of central nervous system (CNS) metastases are allowed at doses exceeding 10 mg/day of prednisone equivalents
Active autoimmune disease requiring systemic treatment within past 1 year
Receipt of live attenuated vaccine within 30 days of enrollment
Use of prohibited concomitant drug within 30 days of enrollment
Known severe (\>= grade 3 Common Terminology Criteria for Adverse Events \[CTCAE\]) hypersensitivity to study intervention or formulation
Concurrent enrollment in another clinical trial (unless observational or within follow-up period)
Any condition at discretion of investigator that will preclude participation in the study
What this trial measures
- Incidence of adverse eventsUp to 2 years
Safety endpoints will be tabulated using descriptive statistics, and by appropriate subgroups. The incidence of adverse events will be summarized according to organ system in terms of severity by Common Terminology Criteria for Adverse Events and relationship to treatment
- Best overall response rateWithin 6 months
By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Exact binomial test and 95% confidence interval (CI) will be used.