Liver MetastasesPhase 1NCT05430009
Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
A Phase 1 study testing Liver SBRT and Pembrolizumab in people with Liver Metastases and Non-small Cell Lung Cancer, run by VA Ann Arbor Healthcare System at 1 site in United States.
Trial summary
Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Non-small Cell Lung Cancer
- What is being tested?
- Liver SBRT and Pembrolizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 15 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years of age)
- Histologically or cytologically confirmed NSCLC with liver metastases
- Eligible for immune checkpoint inhibitors per treating medical oncologist
- Disease must be measurable per RECIST criteria
- ECOG Performance status of 0 - 2
- Adequate organ function per protocol.
Show all 9Show fewer
- Allowable prior therapy includes adjuvant durvalumab, prior radiotherapy outside the upper abdomen.
- Patients must be willing and able to sign an informed consent form.
- Participants of childbearing potential willing to undergo pregnancy test and use contraception per Appendix.
Who cannot join
- Liver tumor burden which cannot be targeted with SBRT per treating radiation oncologist
- Presence of uncontrolled intercurrent illness or significant comorbidities precluding participation in a clinical study as determined by investigator
- Diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis).
- Other invasive malignancy active within 1 years, excluding in situ cancers
- Presence of psychiatric or substance abuse disorders that would interfere with compliance or safety
- Has a known history of active Bacillus Tuberculosis (TB), Hepatitis B or Hepatitis C infection
Show all 10Show fewer
- Has received a live (active) vaccine within 30 days of enrollment.
- Active autoimmune disease that has required systemic treatment in the past 1 years aside from hormone replacement therapy (ie. thyroxine, insulin, or physiologic corticosteroid replacement therapy)
- Baseline corticosteroid use (>10 mg prednisone daily or equivalent) at study entry
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veterans Affairs Ann Arbor Healthcare System
Ann Arbor, Michigan, 48109
Michael D Green, MD, PhD, 734-845-3914, migr@med.umich.edu
About this study
Official title: Phase I Trial of Feasibility and Safety of Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases.
- Conditions
- Liver Metastases, Non-small Cell Lung Cancer
- Being tested
- Liver SBRT, Pembrolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver SBRTRadiation
24-45 Gy delivered in 3-5 fractions to 1-4 lesions.
PembrolizumabDrug
200 mg every 3 weeks or 400 mg every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | This is an open-label, single-arm, single center clinical trial to evaluate the feasibility of liver SBRT (up to 4 metastases) during the first cycle of physician's choice ICI for NSCLC. Receives: Radiation: Liver SBRT; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who receive all fractions of radiotherapy as planned
Feasibility determination. Analyzed with descriptive statistics.
Measured: Up to 0.5 years after start of study treatment
Secondary outcomes (4)
Proportion of patients who develop grade 3 or higher toxicity
Any serious adverse event that occurs within 60 days after treatment with SBRT or after this time frame and is considered related to the study treatment will also be reported. Analyzed with descriptive statistics.
Measured: Up to 1 year after start of study treatment
Progression-free survival
PFS defined as the time from start of treatment to date of radiological or clinical progression (leading to withdrawal from the study), or death from any cause, whichever comes first. Assessed Per RECIST v1.1; analyzed using Kaplan-Meier curves and descriptive statistics.
Measured: Time Frame: Up to 3 years after end of study treatment
Overall survival (OS)
OS defined as the time from start of treatment to death. This will be analyzed using Kaplan-Meier curves and descriptive statistics.
Measured: Time Frame: Up to 3 years after end of study treatment
Proportion of patients with local control
Freedom from local progression (local control) is defined as the lack of progression of the tumors treated by RT, either by tumor size or enhancement. Progression or development of new tumors elsewhere in the liver or outside of the liver would not constitute a local control failure. Tumors which increase in size or demonstrate new or increasing enhancement are considered progression. Analyzed using Kaplan-Meier curves and descriptive statistics.
Measured: Time Frame: Up to 3 years after end of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start17 Jun 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Ann Arbor Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- LUNGevity Foundation
- Responsible party
- Principal investigator, Michael Green, VA Ann Arbor Healthcare System
- Investigators
- Michael Green, MD, Principal investigator, VA Ann Arbor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430009
- Sponsor's protocol ID
- 1652440
- Status last verified
- Jul 2022
- First submitted
- 17 Jun 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Feasibility and Safety of Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05430009
- Acronym / sponsor ID
- 1652440
- Conditions
- Liver Metastases, Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- VA Ann Arbor Healthcare SystemUS federal agency
- Collaborators
- LUNGevity Foundation
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: Liver SBRT, Drug: PembrolizumabThis is an open-label, single-arm, single center clinical trial to evaluate the feasibility of liver SBRT (up to 4 metastases) during the first cycle of physician's choice ICI for NSCLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients (≥18 years of age)
- Histologically or cytologically confirmed NSCLC with liver metastases
- Eligible for immune checkpoint inhibitors per treating medical oncologist
- Disease must be measurable per RECIST criteria
- ECOG Performance status of 0 - 2
Key exclusion criteria (10 listed)
- Liver tumor burden which cannot be targeted with SBRT per treating radiation oncologist
- Presence of uncontrolled intercurrent illness or significant comorbidities precluding participation in a clinical study as determined by investigator
- Diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis).
- Other invasive malignancy active within 1 years, excluding in situ cancers
- Presence of psychiatric or substance abuse disorders that would interfere with compliance or safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver SBRT24-45 Gy delivered in 3-5 fractions to 1-4 lesions. | Radiation | Arm 1 |
| Pembrolizumab200 mg every 3 weeks or 400 mg every 6 weeks | Drug | Arm 1 |
Primary outcome
Percentage of patients who receive all fractions of radiotherapy as planned
Time frame: Up to 0.5 years after start of study treatment
Feasibility determination. Analyzed with descriptive statistics.
4 secondary outcomes
Proportion of patients who develop grade 3 or higher toxicity
Time frame: Up to 1 year after start of study treatment
Progression-free survival
Time frame: Time Frame: Up to 3 years after end of study treatment
Overall survival (OS)
Time frame: Time Frame: Up to 3 years after end of study treatment
Proportion of patients with local control
Time frame: Time Frame: Up to 3 years after end of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Liver Metastases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Green, MD principal investigator
VA Ann Arbor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liver SBRT and Pembrolizumab in people with Liver Metastases and Non-small Cell Lung Cancer, run by VA Ann Arbor Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Green, MD (734-845-3914, Michael.Green4@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who receive all fractions of radiotherapy as planned (time frame: Up to 0.5 years after start of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.