Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
October 16, 2024 updated by: Evan Osmundson, MD, PhD, Vanderbilt-Ingram Cancer Center
SiCARIO (Split Course Adaptive Radioimmunotherapy) for the Treatment of Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Using Biologically-Adaptive Radiotherapy - A Phase I/II Study
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.
Study Overview
Status
Recruiting
Intervention / Treatment
- Radiation: Radiation Therapy
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
- Other: Fludeoxyglucose F-18
- Drug: Carboplatin
- Drug: Nab-paclitaxel
- Biological: Pembrolizumab
- Drug: Pemetrexed
- Other: [18-F] (fluoropropyl)-L-glutamate (FSPG) PET scan
- Biological: Ipilimumab
- Biological: Nivolumab
- Biological: Cemiplimab
- Biological: Atezolizumab
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.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vanderbilt-Ingram Service for Timely Access
- Phone Number: 800-811-8480
- Email: cip@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University/Ingram Cancer Center
-
Principal Investigator:
- Evan Osmundson, MD, PhD
-
Contact:
- Vanderbilt-Ingram Service for Timely Access
- Phone Number: 800-811-8480
- Email: cip@vumc.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1 (carboplatin, pemetrexed, pembrolizumab, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given carboplatin
Other Names:
Given pembrolizumab
Other Names:
Given pemetrexed
Other Names:
Undergo PET scan
|
|
Experimental: Arm II (carboplatin, pemetrexed, cemiplimab, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given carboplatin
Other Names:
Given pemetrexed
Other Names:
Undergo PET scan
Given Cemiplimab
|
|
Experimental: Arm III (carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given carboplatin
Other Names:
Given nab-paclitaxel
Other Names:
Undergo PET scan
Given Cemiplimab
|
|
Experimental: Arm IV (Carbo, pemetrexed, nivolumab, ipilimumab, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given carboplatin
Other Names:
Given pemetrexed
Other Names:
Undergo PET scan
Given Ipilimumab
Given Nivolumab
|
|
Experimental: Arm V (Carboplatin, paclitaxel, pembrolizumab, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given carboplatin
Other Names:
Given nab-paclitaxel
Other Names:
Given pembrolizumab
Other Names:
Undergo PET scan
|
|
Experimental: Arm VI (Carboplatin, paclitaxel, cemiplimab-rwlc, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given carboplatin
Other Names:
Given nab-paclitaxel
Other Names:
Undergo PET scan
Given Cemiplimab
|
|
Experimental: Arm VII (carbo, paclitaxel, nivolumab, ipilimumab, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given carboplatin
Other Names:
Given nab-paclitaxel
Other Names:
Undergo PET scan
Given Ipilimumab
Given Nivolumab
|
|
Experimental: Arm VIII (pembrolizumab, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Given pembrolizumab
Other Names:
Undergo PET scan
|
|
Experimental: Arm IX (atezolizumab, radiation)
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.
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Undergo PET scan
Given Atezolizumab
|
|
Experimental: Arm X (cemiplimab-rwlc, radiation)
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. 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. |
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Undergo PET scan
Given Cemiplimab
|
|
Experimental: Arm XI (nivolumab, ipilumumab, radiation)
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.
|
Undergo radiation therapy
Other Names:
Correlative studies
Other Names:
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Given IV
Other Names:
Undergo PET scan
Given Ipilimumab
Given Nivolumab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of adverse events
Time Frame: Up 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
|
Up to 2 years
|
|
Best overall response rate
Time Frame: Within 6 months
|
By Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Exact binomial test and 95% confidence interval (CI) will be used.
|
Within 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression free survival (PFS)
Time Frame: Time from consent to the date of first documentation of objective progressive disease assessed by RECIST 1.1 or death, assessed at 6, 9, and 12 months
|
Estimation of the treatment effect by a Cox proportional hazards model (stratified by chemotherapy regimen and PD-L1 expression, each stratum defines separate baseline hazard function); ties handled by replacing the proportional hazards model by the discrete logistic model; 95% CI for the hazard ratio will be calculated.
Kaplan-Meier estimates and associated statistics (PFS rates at 6, 9, 12; median PFS) and corresponding 95% CI will be presented by treatment group.
|
Time from consent to the date of first documentation of objective progressive disease assessed by RECIST 1.1 or death, assessed at 6, 9, and 12 months
|
|
Overall survival
Time Frame: Time from consent to the date of death due to any cause, assessed up to 2 years
|
Estimation of the treatment effect by a Cox proportional hazards model (stratified by chemotherapy regimen and PD-L1 expression, each stratum defines separate baseline hazard function); ties handled by replacing the proportional hazards model by the discrete logistic model; 95% CI for the hazard ratio will be calculated.
Kaplan-Meier estimates and associated statistics and corresponding 95% CI will be presented by treatment group.
|
Time from consent to the date of death due to any cause, assessed up to 2 years
|
|
New metastasis free survival
Time Frame: Time from consent to the date of the first documentation of a new distant metastasis or death, assessed up to 2 years
|
Any new lesions different from the ones present at screening are considered as new metastases.
|
Time from consent to the date of the first documentation of a new distant metastasis or death, assessed up to 2 years
|
|
Quantitative and qualitative markers of planning and treatment resource utilization
Time Frame: Up to 2 years
|
Develop real-world clinical and treatment planning workflows for implementation of the Ethos platform for anatomic and biologically adaptive radiation therapy (RT).
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Evan Osmundson, MD, PhD, Vanderbilt University/Ingram Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2023
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
August 11, 2022
First Submitted That Met QC Criteria
August 11, 2022
First Posted (Actual)
August 15, 2022
Study Record Updates
Last Update Posted (Actual)
October 17, 2024
Last Update Submitted That Met QC Criteria
October 16, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Radiopharmaceuticals
- Immune Checkpoint Inhibitors
- Folic Acid Antagonists
- Carboplatin
- Paclitaxel
- Fluorodeoxyglucose F18
- Nivolumab
- Pembrolizumab
- Albumin-Bound Paclitaxel
- Pemetrexed
- Ipilimumab
- Atezolizumab
- Cemiplimab
- Deoxyglucose
Other Study ID Numbers
- VICCTHOP2185 (Other Identifier: Vanderbilt University/Ingram Cancer Center)
- P30CA068485 (U.S. NIH Grant/Contract)
- NCI-2022-05101 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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M.D. Anderson Cancer CenterCompletedStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
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National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
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PfizerRecruitingNon-small Cell Carcinoma | Non-Small Cell Lung Carcinoma | Non-Small Cell Lung Cancer MetastaticUnited States, United Kingdom, Canada, Taiwan, China, Belgium, Spain, Australia, France, Czechia, India, Slovakia, Japan, Finland, Greece, Denmark, Puerto Rico, Germany, Netherlands, Bulgaria, Italy, Sweden, Mexico, South Korea, Israel, A... and more
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National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyCompletedStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
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PfizerNot yet recruitingCarcinoma | Lung Neoplasms | Non-Small Cell Lung Cancer | Lung Disease | Non-Small-Cell Lung | Carcinoma, Non-Small-Cell Lung (NSCLC) | Non-small Cell Lung Cancer, Squamous | Non-small Cell Lung Cancer, Non-squamous | Lung Cancer (NSCLC)
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
Clinical Trials on Radiation Therapy
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumor | Central Nervous System TumorUnited States, Canada, Australia, Puerto Rico, Switzerland, New Zealand
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University of California, San FranciscoVarian Medical SystemsRecruitingStage IV Anal Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Postneoadjuvant Therapy Stage... and other conditionsUnited States
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Medical College of WisconsinCompletedResectable Head and Neck Squamous Cell CarcinomaUnited States
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Medical College of WisconsinActive, not recruitingHead and Neck CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)Completed
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Changhai HospitalRecruitingLocalized Prostate CancerChina
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NYU Langone HealthCompletedBreast CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
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Ohio State University Comprehensive Cancer CenterCompletedUnspecified Adult Solid Tumor, Protocol Specific | Metastatic CancerUnited States
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Sir Mortimer B. Davis - Jewish General HospitalRecruitingPatients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to RadiationCanada