Trial Title:
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
NCT ID:
NCT05501665
Condition:
Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage III Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Deoxyglucose
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pembrolizumab
Nivolumab
Pemetrexed
Ipilimumab
Atezolizumab
Cemiplimab
Fluorodeoxyglucose F18
Conditions: Keywords:
Oligometastasis
Adaptive Radiotherapy
Immunotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Correlative studies
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm IX (atezolizumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VIII (pembrolizumab, radiation)
Arm group label:
Arm X (cemiplimab-rwlc, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Given carboplatin
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Other name:
Blastocarb
Other name:
Carboplat
Other name:
Carboplatin Hexal
Other name:
Carboplatino
Other name:
Carboplatinum
Other name:
Carbosin
Other name:
Carbosol
Other name:
Carbotec
Other name:
CBDCA
Other name:
Displata
Other name:
Ercar
Other name:
JM-8
Other name:
Nealorin
Other name:
Novoplatinum
Other name:
Paraplatin
Other name:
Paraplatin AQ
Other name:
Paraplatine
Other name:
Platinwas
Other name:
Ribocarbo
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm IX (atezolizumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VIII (pembrolizumab, radiation)
Arm group label:
Arm X (cemiplimab-rwlc, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Fludeoxyglucose F-18
Description:
Given IV
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm IX (atezolizumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VIII (pembrolizumab, radiation)
Arm group label:
Arm X (cemiplimab-rwlc, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Other name:
18FDG
Other name:
FDG
Other name:
Fludeoxyglucose (18F)
Other name:
fludeoxyglucose F 18
Other name:
Fludeoxyglucose F18
Other name:
Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
Other name:
Fluorodeoxyglucose F18
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Given nab-paclitaxel
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Other name:
ABI 007
Other name:
ABI-007
Other name:
Abraxane
Other name:
Albumin-bound Paclitaxel
Other name:
Albumin-Stabilized Nanoparticle Paclitaxel
Other name:
Nanoparticle Albumin-bound Paclitaxel
Other name:
Nanoparticle Paclitaxel
Other name:
Paclitaxel Albumin
Other name:
paclitaxel albumin-stabilized nanoparticle formulation
Other name:
Protein-bound Paclitaxel
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Given pembrolizumab
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VIII (pembrolizumab, radiation)
Other name:
Keytruda
Other name:
Lambrolizumab
Other name:
MK-3475
Other name:
SCH 900475
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Given pemetrexed
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Other name:
MTA
Other name:
Multitargeted Antifolate
Other name:
Pemfexy
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm IX (atezolizumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VIII (pembrolizumab, radiation)
Arm group label:
Arm X (cemiplimab-rwlc, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Undergo radiation therapy
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm IX (atezolizumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VIII (pembrolizumab, radiation)
Arm group label:
Arm X (cemiplimab-rwlc, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Other name:
Cancer Radiotherapy
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Intervention type:
Other
Intervention name:
[18-F] (fluoropropyl)-L-glutamate (FSPG) PET scan
Description:
Undergo PET scan
Arm group label:
Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm IX (atezolizumab, radiation)
Arm group label:
Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VIII (pembrolizumab, radiation)
Arm group label:
Arm X (cemiplimab-rwlc, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Intervention type:
Biological
Intervention name:
Ipilimumab
Description:
Given Ipilimumab
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Intervention type:
Biological
Intervention name:
Nivolumab
Description:
Given Nivolumab
Arm group label:
Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
Arm group label:
Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
Arm group label:
Arm XI (nivolumab, ipilumumab, radiation)
Intervention type:
Biological
Intervention name:
Cemiplimab
Description:
Given Cemiplimab
Arm group label:
Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
Arm group label:
Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
Arm group label:
Arm X (cemiplimab-rwlc, radiation)
Intervention type:
Biological
Intervention name:
Atezolizumab
Description:
Given Atezolizumab
Arm group label:
Arm IX (atezolizumab, radiation)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVES:
I. Evaluate the safety of adaptive split course hypo-fractionated radiation therapy (RT)
with immunotherapy containing systemic regimens.
II. Evaluate efficacy of the use of adaptive split course hypo-fractionated RT with
immunotherapy containing systemic regimens.
SECONDARY OBJECTIVES:
I. Evaluate progression and survival benefit of split course adaptive radioimmunotherapy
(SiCARIO) regimen.
II. Identify potential functional radiomic biomarkers of response to SiCARIO regimen.
III. Develop real-world clinical and treatment planning workflows for implementation of
the Ethos platform for anatomic and biologically adaptive RT.
OUTLINE:
PRIMARY OBJECTIVES:
I. Evaluate the safety of adaptive split course hypo-fractionated radiation therapy (RT)
with immunotherapy containing systemic regimens.
II. Evaluate efficacy of the use of adaptive split course hypo-fractionated RT with
immunotherapy containing systemic regimens.
SECONDARY OBJECTIVES:
I. Evaluate progression and survival benefit of split course adaptive radioimmunotherapy
(SiCARIO) regimen.
II. Identify potential functional radiomic biomarkers of response to SiCARIO regimen.
III. Develop real-world clinical and treatment planning workflows for implementation of
the Ethos platform for anatomic and biologically adaptive RT.
OUTLINE:
Patients are assigned to 1 of 11 standard treatment regimens, in combination with
radiation therapy, as determined by the tumor histology and PD-L1 status.
Patients with non-squamous histology and any PD-L1 status are assigned to arms 1-4.
ARM I: Patients receive carboplatin, pemetrexed, and pembrolizumab on day 1 of each
cycle. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease
progression or unacceptable toxicity. Patients then receive pemetrexed and pembrolizumab
on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease
progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of
each cycle over 5 treatment fractions.
ARM II: Patients receive carboplatin, pemetrexed and cemiplimab-rwlc on day 1 of each
cycle. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease
progression or unacceptable toxicity. Patients then receive pemetrexed and
cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the
absence of disease progression or unacceptable toxicity. Patients also undergo radiation
therapy on day 1 of each cycle over 5 treatment fractions.
ARM III: Patients receive carboplatin, paclitaxel and cemiplimab-rwlc on day 1 of each
cycle. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease
progression or unacceptable toxicity. Patients then receive pemetrexed and
cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the
absence of disease progression or unacceptable toxicity. Patients also undergo radiation
therapy on day 1 of each cycle over 5 treatment fractions.
ARM IV: Patients receive carboplatin, pemetrexed and nivolumab on day 1 of each cycle and
ipilimumab on day 1 of every other cycle. Treatment repeats for up to 2 cycles in the
absence of disease progression or unacceptable toxicity. Patients then continue to
receive ipilmumab and nivolumab on the same schedule for up to 2 years in the absence of
disease progression or unacceptable toxicity. Patients also undergo radiation therapy on
day 1 of each cycle over 5 treatment fractions.
Patients with squamous histology and any PD-L1 histology are assigned to arms 5-7
ARM V: Patients receive carboplatin, paclitaxel, and pembrolizumab on day 1 of each
cycle. Treatment repeats every 3 weeks for 4 up to cycles in the absence of disease
progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of
each cycle over 5 treatment fractions. Patients then receive pembrolizumab on day 1 of
each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression
or unacceptable toxicity.
ARM VI: Patients receive carboplatin, paclitaxel, and cemiplimab-rwlc on day 1 of each
cycle. Treatment repeats every 3 weeks for 4 up to cycles in the absence of disease
progression or unacceptable toxicity. Patients also undergo radiation therapy on day 1 of
each cycle over 5 treatment fractions. Patients then receive cemiplimab-rwlc on day 1 of
each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression
or unacceptable toxicity.
ARM VII: Patients receive carboplatin, paclitaxel and nivolumab on day 1 of each cycle
and ipilimumab on day 1 of every other cycle. Treatment repeats for up to 2 cycles in the
absence of disease progression or unacceptable toxicity. Patients then continue to
receive ipilmumab and nivolumab on the same schedule for up to 2 years in the absence of
disease progression or unacceptable toxicity. Patients also undergo radiation therapy on
day 1 of each cycle over 5 treatment fractions.
Patients with PD-L1 ≥ 50% are assigned to arms 8-10
ARM VIII: Patients receive pembrolizumab on day 1 of each cycle. Cycles repeat every 3
weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment
fractions.
ARM IX: Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 3 weeks
for 2 years in the absence of disease progression or unacceptable toxicity. Patients also
undergo radiation therapy on day 1 of each cycle over 5 treatment fractions.
ARM X: Patients receive cemiplimab-rwlc on day 1 of each cycle. Cycles repeat every 3
weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Patients also undergo radiation therapy on day 1 of each cycle over 5 treatment
fractions.
Patients with any PD-L1 status or histology who are not a chemotherapy candidate are
assigned to arm 11
ARM XI: Patients receive ipilmumab every 6 weeks and nivolumab every 3 weeks for up to 2
years in the absence of disease progression or unacceptable toxicity. Patients also
undergo radiation therapy on day 1 of each cycle over 5 treatment fractions.
All patients also receive fludeoxyglucose F-18 intravenously and fluorine F 18
florilglutamic acid IV and undergo PET/ CT during screening and on study. Patients also
undergo collection of blood samples, as well as CT and MRI throughout the trial.
After completion of study treatment, patients are followed up at 4 weeks, 12 weeks, and
then every 12 weeks for 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vanderbilt-Ingram Service for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Evan Osmundson, MD, PhD
Email:
Principal Investigator
Start date:
May 9, 2023
Completion date:
February 1, 2027
Lead sponsor:
Agency:
Vanderbilt-Ingram Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Varian Medical Systems
Agency class:
Industry
Source:
Vanderbilt-Ingram Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05501665