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Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative

Primary Purpose

Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Non-Small Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Biospecimen Collection
Carboplatin
Computed Tomography
Echocardiography
Ipilimumab
Magnetic Resonance Imaging
Nab-paclitaxel
Nivolumab
Paclitaxel
Pembrolizumab
Pemetrexed
Positron Emission Tomography
Quality-of-Life Assessment
Stereotactic Body Radiation Therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with Stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation
  • PD-L1 expression tumor proportion score (TPS) < 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded
  • For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors
  • Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for stereotactic body radiation therapy (SBRT)
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • No prior systemic chemotherapy or immunotherapy for advanced NSCLC
  • No prior treatment with checkpoint inhibitors for metastatic lung cancer
  • Chemotherapy for non-metastatic disease (e.g., adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if terminated at least 6 months prior to registration
  • No systemic immunostimulatory or immunosuppressive drugs, including > 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter
  • >= 1 week since palliative (including central nervous system [CNS]) radiotherapy to any tumor site
  • No prior allogeneic tissue/solid organ transplant
  • No uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
  • No current pneumonitis or history of non-infectious pneumonitis that required steroids
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration
  • No active auto-immune disease that requires systemic therapy within 2 years prior to registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
  • No known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection
  • No patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with small asymptomatic brain metastases are eligible as are patients with treated brain metastases that require no steroids
  • Not pregnant and not nursing, because this study involves radiation as well as potentially chemotherapy which have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to registration is required
  • No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 2 years. Participants with non-melanoma skin cancers or carcinoma in-situ (e.g., breast carcinoma, urothelial carcinoma or cervical cancer in situ) or localized prostate cancer (T1-3, N0, M0) that have undergone potentially curative therapy are eligible
  • No hypersensitivity (>= grade 3) to immunotherapy and/or any of its excipients
  • No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,FluMist) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Calculated (Calc.) creatinine clearance >= 45 mL/min
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

Sites / Locations

  • Mayo Clinic Hospital in ArizonaRecruiting
  • Alta Bates Summit Medical Center-Herrick CampusRecruiting
  • City of Hope Comprehensive Cancer CenterRecruiting
  • City of Hope Antelope ValleyRecruiting
  • Fremont - Rideout Cancer CenterRecruiting
  • Providence Queen of The ValleyRecruiting
  • University of California Davis Comprehensive Cancer CenterRecruiting
  • City of Hope South PasadenaRecruiting
  • Gene Upshaw Memorial Tahoe Forest Cancer CenterRecruiting
  • City of Hope UplandRecruiting
  • UCHealth Memorial Hospital CentralRecruiting
  • Memorial Hospital NorthRecruiting
  • Poudre Valley HospitalRecruiting
  • Cancer Care and Hematology-Fort CollinsRecruiting
  • UCHealth Greeley HospitalRecruiting
  • Medical Center of the RockiesRecruiting
  • Beebe South Coastal Health CampusRecruiting
  • Helen F Graham Cancer CenterRecruiting
  • Medical Oncology Hematology Consultants PARecruiting
  • Beebe Health CampusRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
  • Saint Luke's Cancer Institute - BoiseRecruiting
  • Saint Luke's Cancer Institute - FruitlandRecruiting
  • Saint Luke's Cancer Institute - MeridianRecruiting
  • Saint Luke's Cancer Institute - NampaRecruiting
  • Saint Luke's Cancer Institute - Twin FallsRecruiting
  • Northwestern UniversityRecruiting
  • University of IllinoisRecruiting
  • University of Chicago Comprehensive Cancer Center
  • Carle at The RiverfrontRecruiting
  • Decatur Memorial HospitalRecruiting
  • Northwestern Medicine Cancer Center KishwaukeeRecruiting
  • Carle Physician Group-EffinghamRecruiting
  • Crossroads Cancer CenterRecruiting
  • Northwestern Medicine Cancer Center DelnorRecruiting
  • Ingalls Memorial HospitalRecruiting
  • Northwestern Medicine Lake Forest HospitalRecruiting
  • Carle Physician Group-Mattoon/CharlestonRecruiting
  • UC Comprehensive Cancer Center at Silver Cross
  • University of Chicago Medicine-Orland ParkRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Springfield ClinicRecruiting
  • Memorial Medical CenterRecruiting
  • Carle Cancer CenterRecruiting
  • Northwestern Medicine Cancer Center WarrenvilleRecruiting
  • Mary Greeley Medical CenterRecruiting
  • McFarland Clinic - AmesRecruiting
  • Medical Oncology and Hematology Associates-West Des MoinesRecruiting
  • Mercy Cancer Center-West LakesRecruiting
  • Greater Regional Medical CenterRecruiting
  • Mercy Medical Center - Des MoinesRecruiting
  • Mission Cancer and Blood - LaurelRecruiting
  • Mercy Medical Center-West LakesRecruiting
  • Saint Joseph Hospital EastRecruiting
  • University of Kentucky/Markey Cancer CenterRecruiting
  • MaineHealth Cancer Care Center of York CountyRecruiting
  • Maine Medical Center- Scarborough CampusRecruiting
  • Maine Medical Partners - South PortlandRecruiting
  • Saint Joseph Mercy HospitalRecruiting
  • Saint Joseph Mercy BrightonRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
  • Saint Joseph Mercy CantonRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
  • Saint Joseph Mercy ChelseaRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
  • Genesys Hurley Cancer InstituteRecruiting
  • Hurley Medical CenterRecruiting
  • Bronson Methodist HospitalRecruiting
  • West Michigan Cancer CenterRecruiting
  • Sparrow HospitalRecruiting
  • Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
  • Hennepin County Medical CenterRecruiting
  • North Memorial Medical Health CenterRecruiting
  • Regions HospitalRecruiting
  • Saint Francis Medical CenterRecruiting
  • Parkland Health Center - FarmingtonRecruiting
  • Delbert Day Cancer Institute at PCRMCRecruiting
  • Missouri Baptist Medical CenterRecruiting
  • Sainte Genevieve County Memorial HospitalRecruiting
  • Missouri Baptist Sullivan HospitalRecruiting
  • Missouri Baptist Outpatient Center-Sunset HillsRecruiting
  • Roswell Park Cancer Institute
  • Mount Sinai ChelseaRecruiting
  • Mount Sinai WestRecruiting
  • Mount Sinai HospitalRecruiting
  • Upstate Cancer Center at OswegoRecruiting
  • State University of New York Upstate Medical UniversityRecruiting
  • SUNY Upstate Medical Center-Community CampusRecruiting
  • Upstate Cancer Center Hematology Oncology at VeronaRecruiting
  • Duke University Medical CenterRecruiting
  • Duke Raleigh HospitalRecruiting
  • Wake Forest University Health SciencesRecruiting
  • Summa Health System - Akron CampusRecruiting
  • Cancer Centers of Southwest Oklahoma ResearchRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Christiana Care Health System-Concord Health CenterRecruiting
  • Geisinger Medical CenterRecruiting
  • Penn State Milton S Hershey Medical CenterRecruiting
  • Geisinger Medical Oncology-LewisburgRecruiting
  • Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • The Don and Sybil Harrington Cancer CenterRecruiting
  • Marshfield Medical Center-EC Cancer CenterRecruiting
  • Gundersen Lutheran Medical CenterRecruiting
  • Mayo Clinic Health System-Franciscan HealthcareRecruiting
  • Marshfield Medical Center-MarshfieldRecruiting
  • Marshfield Clinic-Minocqua CenterRecruiting
  • ProHealth D N Greenwald CenterRecruiting
  • ProHealth Oconomowoc Memorial HospitalRecruiting
  • Marshfield Medical Center-River Region at Stevens PointRecruiting
  • UW Cancer Center at ProHealth CareRecruiting
  • Marshfield Medical Center - WestonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A (immunotherapy, +/- chemotherapy)

Arm B (immunotherapy, +/- chemotherapy, SBRT)

Arm Description

See Detailed Description

Patients receive 1 of 6 treatment options as in Arm A. Patients also undergo 3 fractions of SBRT every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) (Phase II)
Will be performed on an intent-to-treat (ITT) basis.
Overall survival (OS) (Phase III)
Will be performed on an ITT basis. The comparison of the distributions of OS between treatment arms will be done with a one-sided stratified log-rank test). The rates at various time points (e.g., every 6 months after randomization) and medians of OS for each arm will be estimated using the Kaplan-Meier estimator. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios will be estimated using a stratified Cox regression model. The final phase III analysis of OS will be considered as "positive" if the stratified log-rank test statistics Z-value greater than the critical value adjusted for type 1 error using group sequential methods. Multivariable Cox models will be used to evaluate the treatment effect on survival time and its interaction with baseline covariates, including stage, systemic therapy, histology and performance status.

Secondary Outcome Measures

PFS
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST).
Objective response rate (ORR)
Assessed per RECIST for both irradiated and un-irradiated areas. The ORRs between treatments will be compared with Fisher's exact test. The difference of ORR between treatments will be estimated by the Miettinen-Nurminen method and its 95% CI will be given. Multivariable logistic regression will be used to evaluate the treatment effect on ORR while adjusting for significant baseline covariates.
Quality of life
Incidence of treatment-related adverse events
Treatment-related toxicity will be summarized by grade, type, and system organ class. Comparisons of the percentages of patients experiencing an adverse event between Arm A and Arm B will be performed using Fisher's exact test.

Full Information

First Posted
June 16, 2021
Last Updated
October 24, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04929041
Brief Title
Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative
Official Title
A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy [carboplatin, pemetrexed, paclitaxel, nab-paclitaxel]) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.
Detailed Description
PRIMARY OBJECTIVE: I. To assess if stereotactic body radiation therapy (SBRT) improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage non-small cell lung cancer (NSCLC) patients with PD-L1 tumor proportion score (TPS) < 1% who receive immunotherapy with or without chemotherapy. SECONDARY OBJECTIVES: I. To estimate and compare the rates of >= grade 3-4 and all grade adverse events by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 between the arms. II. To summarize and compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) between the arms. III. To determine and compare the objective response rate (ORR) per RECIST between the arms (including at both irradiated and un-irradiated sites). QUALITY OF LIFE (QOL) OBJECTIVE: I. To assess the health-related QOL in both treatment arms. CORRELATIVE SCIENCE OBJECTIVE: I. To evaluate changes in the peripheral immune microenvironment between the arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive 1 of 6 treatment options. Some patients receive immunotherapy alone whether they have squamous or non-squamous histology. OPTION 1: Patients receive nivolumab intravenously (IV) over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET) throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as echocardiography (ECHO) during screening. Patients with non-squamous histology receive 1 of 2 options. OPTION 2: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, carboplatin IV on days 1 and 22 of cycles 1 and 2, and pemetrexed IV over 10 minutes on days 1 and 22 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening. OPTION 3: Patients receive nivolumab IV over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Patients also receive carboplatin IV on days 1 and 22 of cycle 1 and pemetrexed IV over 10 minutes on days 1 and 22 of cycle 1. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening. Patients with squamous histology receive 1 of 3 options. OPTION 4: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Patients also receive carboplatin IV and paclitaxel IV over 1-96 hours on days 1 and 22 of cycles 1 and 2. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening. OPTION 5: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Patients also receive carboplatin IV on days 1 and 22 of cycles 1 and 2, and nab-paclitaxel IV over 30 minutes on days 1, 8, 15, 22, 29 and 36 of cycles 1 and 2. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening. OPTION 6: Patients receive nivolumab IV over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on days 1 of each cycle. Patients also receive carboplatin IV and paclitaxel IV over 1-96 hours on days 1 and 22 of cycle 1. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening. Arm B: Patients receive 1 of 6 treatment options as in Arm A. Patients also undergo 3 fractions of SBRT every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening. After completion of study treatment, patients are followed up every 3 months for 3 years and then every 6 months for years 4-5 following randomization until disease progression. Following disease progression patients are followed for survival every 6 months for up to 5 years following randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
427 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (immunotherapy, +/- chemotherapy)
Arm Type
Experimental
Arm Description
See Detailed Description
Arm Title
Arm B (immunotherapy, +/- chemotherapy, SBRT)
Arm Type
Experimental
Arm Description
Patients receive 1 of 6 treatment options as in Arm A. Patients also undergo 3 fractions of SBRT every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
BIOPSY_TYPE, Bx
Intervention Description
Undergo tissue biopsy
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood sample collection
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Other Intervention Name(s)
EC
Intervention Description
Undergo ECHO
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Paclitaxel Nanoparticle Albumin-bound, Paclitaxel Protein-Bound, Protein-bound Paclitaxel
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
ABP 206, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, SCH 900475
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
MTA, Multitargeted Antifolate, Pemfexy
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PET
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) (Phase II)
Description
Will be performed on an intent-to-treat (ITT) basis.
Time Frame
From randomization to disease progression or death of all causes, whichever comes first, assessed up to 5 years
Title
Overall survival (OS) (Phase III)
Description
Will be performed on an ITT basis. The comparison of the distributions of OS between treatment arms will be done with a one-sided stratified log-rank test). The rates at various time points (e.g., every 6 months after randomization) and medians of OS for each arm will be estimated using the Kaplan-Meier estimator. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios will be estimated using a stratified Cox regression model. The final phase III analysis of OS will be considered as "positive" if the stratified log-rank test statistics Z-value greater than the critical value adjusted for type 1 error using group sequential methods. Multivariable Cox models will be used to evaluate the treatment effect on survival time and its interaction with baseline covariates, including stage, systemic therapy, histology and performance status.
Time Frame
From randomization and death of all causes, assessed up to 5 years
Secondary Outcome Measure Information:
Title
PFS
Description
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame
From randomization to disease progression or death of all causes, whichever comes first, assessed up to 5 years
Title
Objective response rate (ORR)
Description
Assessed per RECIST for both irradiated and un-irradiated areas. The ORRs between treatments will be compared with Fisher's exact test. The difference of ORR between treatments will be estimated by the Miettinen-Nurminen method and its 95% CI will be given. Multivariable logistic regression will be used to evaluate the treatment effect on ORR while adjusting for significant baseline covariates.
Time Frame
Up to 5 years
Title
Quality of life
Time Frame
Up to 5 years
Title
Incidence of treatment-related adverse events
Description
Treatment-related toxicity will be summarized by grade, type, and system organ class. Comparisons of the percentages of patients experiencing an adverse event between Arm A and Arm B will be performed using Fisher's exact test.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation PD-L1 expression tumor proportion score (TPS) < 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for SBRT Age >= 18 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 No prior systemic chemotherapy or immunotherapy for advanced NSCLC No prior treatment with checkpoint inhibitors for metastatic lung cancer Chemotherapy for non-metastatic disease (e.g., adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if terminated at least 6 months prior to registration No systemic immunostimulatory or immunosuppressive drugs, including > 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter >= 1 week prior to registration since palliative (including central nervous system [CNS]) radiotherapy to any tumor site No prior allogeneic tissue/solid organ transplant No uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements No current pneumonitis or history of non-infectious pneumonitis that required steroids Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration No active auto-immune disease that requires systemic therapy within 2 years prior to registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment No known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection No patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with small asymptomatic brain metastases are eligible as are patients with treated brain metastases that require no steroids Not pregnant and not nursing, because this study involves radiation as well as potentially chemotherapy which have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to registration is required No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 2 years. Participants with non-melanoma skin cancers or carcinoma in-situ (e.g., breast carcinoma, urothelial carcinoma or cervical cancer in situ) or localized prostate cancer (T1-3, N0, M0) that have undergone potentially curative therapy are eligible No hypersensitivity (>= grade 3) to immunotherapy and/or any of its excipients No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,FluMist [registered trademark]) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Calculated (Calc.) creatinine clearance >= 45 mL/min Total bilirubin =< 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven E Schild
Organizational Affiliation
Alliance for Clinical Trials in Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Terence T. Sio
Facility Name
Alta Bates Summit Medical Center-Herrick Campus
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
Melanie.Cook@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Uma Suryadevara
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-826-4673
Email
becomingapatient@coh.org
First Name & Middle Initial & Last Name & Degree
Arya Amini
Facility Name
City of Hope Antelope Valley
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-826-4673
Email
becomingapatient@coh.org
First Name & Middle Initial & Last Name & Degree
Arya Amini
Facility Name
Fremont - Rideout Cancer Center
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
530-749-4400
First Name & Middle Initial & Last Name & Degree
Megan E. Daly
Facility Name
Providence Queen of The Valley
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
707-521-3830
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
916-734-3089
First Name & Middle Initial & Last Name & Degree
Megan E. Daly
Facility Name
City of Hope South Pasadena
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-826-4673
Email
becomingapatient@coh.org
First Name & Middle Initial & Last Name & Degree
Arya Amini
Facility Name
Gene Upshaw Memorial Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
530-582-6450
First Name & Middle Initial & Last Name & Degree
Megan E. Daly
Facility Name
City of Hope Upland
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-826-4673
Email
becomingapatient@coh.org
First Name & Middle Initial & Last Name & Degree
Arya Amini
Facility Name
UCHealth Memorial Hospital Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
719-365-2406
First Name & Middle Initial & Last Name & Degree
Lynn M. Mathew
Facility Name
Memorial Hospital North
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
719-364-6700
First Name & Middle Initial & Last Name & Degree
Lynn M. Mathew
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
970-297-6150
First Name & Middle Initial & Last Name & Degree
Lynn M. Mathew
Facility Name
Cancer Care and Hematology-Fort Collins
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-9171
Email
protocols@AllianceNCTN.org
First Name & Middle Initial & Last Name & Degree
Lynn M. Mathew
Facility Name
UCHealth Greeley Hospital
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-9171
Email
protocols@AllianceNCTN.org
First Name & Middle Initial & Last Name & Degree
Lynn M. Mathew
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
970-203-7083
First Name & Middle Initial & Last Name & Degree
Lynn M. Mathew
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-291-6730
Email
research@beebehealthcare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
202-877-8839
First Name & Middle Initial & Last Name & Degree
Irina G. Veytsman
Facility Name
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
912-819-5704
Email
underberga@sjchs.org
First Name & Middle Initial & Last Name & Degree
Joshua T. Mckenzie
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Alison K. Conlin
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-695-1301
Email
cancer@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-355-3046
First Name & Middle Initial & Last Name & Degree
Frank Weinberg
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Christine M. Bestvina
Facility Name
Carle at The Riverfront
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@Carle.com
First Name & Middle Initial & Last Name & Degree
Sinisa Stanic
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Northwestern Medicine Cancer Center Kishwaukee
City
DeKalb
State/Province
Illinois
ZIP/Postal Code
60115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Sinisa Stanic
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-876-4762
Email
morganthaler.jodi@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
708-915-4673
Email
clinicaltrials@ingalls.org
First Name & Middle Initial & Last Name & Degree
James A. Wallace
Facility Name
Northwestern Medicine Lake Forest Hospital
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
cancertrials@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Sinisa Stanic
Facility Name
UC Comprehensive Cancer Center at Silver Cross
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Christine M. Bestvina
Facility Name
University of Chicago Medicine-Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
773-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Christine M. Bestvina
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-545-7929
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-444-7541
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
217-528-7541
Email
pallante.beth@mhsil.com
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Sinisa Stanic
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
630-352-5360
Email
Donald.Smith3@nm.org
First Name & Middle Initial & Last Name & Degree
Young Kwang Chae
Facility Name
Mary Greeley Medical Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-956-4132
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
McFarland Clinic - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-239-4734
Email
ksoder@mcfarlandclinic.com
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Greater Regional Medical Center
City
Creston
State/Province
Iowa
ZIP/Postal Code
50801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-241-3305
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
Saint Joseph Hospital East
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
859-629-7169
Email
ResearchInstituteInquiries@CommonSpirit.org
First Name & Middle Initial & Last Name & Degree
Shahzad Siddique
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
859-257-3379
First Name & Middle Initial & Last Name & Degree
John L. Villano
Facility Name
MaineHealth Cancer Care Center of York County
City
Sanford
State/Province
Maine
ZIP/Postal Code
04073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-459-1600
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Maine Medical Center- Scarborough Campus
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-8090
Email
wrighd@mmc.org
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Maine Medical Partners - South Portland
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
207-396-8670
Email
ClinicalResearch@mmc.org
First Name & Middle Initial & Last Name & Degree
Matthew D. Cheney
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Saint Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
810-762-8038
Email
wstrong@ghci.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
616-391-1230
Email
crcwm-regulatory@crcwm.org
First Name & Middle Initial & Last Name & Degree
Kathleen J. Yost
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
517-364-9400
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Trinity Health Saint Mary Mercy Livonia Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
734-712-7251
Email
MCRCwebsitecontactform@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Christopher M. Reynolds
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Daniel M. Anderson
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Daniel M. Anderson
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Daniel M. Anderson
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
573-334-2230
Email
sfmc@sfmc.net
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Parkland Health Center - Farmington
City
Farmington
State/Province
Missouri
ZIP/Postal Code
63640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
573-458-7504
Email
research@phelpshealth.org
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Sainte Genevieve County Memorial Hospital
City
Sainte Genevieve
State/Province
Missouri
ZIP/Postal Code
63670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Missouri Baptist Sullivan Hospital
City
Sullivan
State/Province
Missouri
ZIP/Postal Code
63080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Missouri Baptist Outpatient Center-Sunset Hills
City
Sunset Hills
State/Province
Missouri
ZIP/Postal Code
63127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
314-996-5569
First Name & Middle Initial & Last Name & Degree
Bryan A. Faller
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mount Sinai Chelsea
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-824-7309
Email
CCTO@mssm.edu
First Name & Middle Initial & Last Name & Degree
Robert M. Samstein
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-824-7309
Email
CCTO@mssm.edu
First Name & Middle Initial & Last Name & Degree
Robert M. Samstein
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-824-7309
Email
CCTO@mssm.edu
First Name & Middle Initial & Last Name & Degree
Robert M. Samstein
Facility Name
Upstate Cancer Center at Oswego
City
Oswego
State/Province
New York
ZIP/Postal Code
13126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
315-464-8230
Email
McDowelE@upstate.edu
First Name & Middle Initial & Last Name & Degree
Michael D. Mix
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
315-464-5476
First Name & Middle Initial & Last Name & Degree
Michael D. Mix
Facility Name
SUNY Upstate Medical Center-Community Campus
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
315-464-5476
First Name & Middle Initial & Last Name & Degree
Michael D. Mix
Facility Name
Upstate Cancer Center Hematology Oncology at Verona
City
Verona
State/Province
New York
ZIP/Postal Code
13478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
315-464-8230
Email
McDowelE@upstate.edu
First Name & Middle Initial & Last Name & Degree
Michael D. Mix
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-275-3853
First Name & Middle Initial & Last Name & Degree
Thomas E. Stinchcombe
Facility Name
Duke Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
919-862-5400
First Name & Middle Initial & Last Name & Degree
Thomas E. Stinchcombe
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
336-713-6771
First Name & Middle Initial & Last Name & Degree
Michael K. Farris
Facility Name
Summa Health System - Akron Campus
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
330-375-4221
Email
cancerresearch@summahealth.org
First Name & Middle Initial & Last Name & Degree
Desiree E. Doncals
Facility Name
Cancer Centers of Southwest Oklahoma Research
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-231-4440
First Name & Middle Initial & Last Name & Degree
Raid Aljumaily
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Raid Aljumaily
Facility Name
Christiana Care Health System-Concord Health Center
City
Chadds Ford
State/Province
Pennsylvania
ZIP/Postal Code
19317
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
302-623-4450
Email
lbarone@christianacare.org
First Name & Middle Initial & Last Name & Degree
Gregory A. Masters
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Eric Kemmerer
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-531-3779
Email
CTO@hmc.psu.edu
First Name & Middle Initial & Last Name & Degree
Joseph A. Miccio
Facility Name
Geisinger Medical Oncology-Lewisburg
City
Lewisburg
State/Province
Pennsylvania
ZIP/Postal Code
17837
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-374-8555
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Eric Kemmerer
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Eric Kemmerer
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
843-792-9321
Email
hcc-clinical-trials@musc.edu
First Name & Middle Initial & Last Name & Degree
Mariam Alexander
Facility Name
The Don and Sybil Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
806-212-1985
Email
Gina.Cravey@bsahs.org
First Name & Middle Initial & Last Name & Degree
Anita Ravipati
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Demet Gokalp Yasar
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
608-775-2385
Email
cancerctr@gundersenhealth.org
First Name & Middle Initial & Last Name & Degree
Michael O. Ojelabi
Facility Name
Mayo Clinic Health System-Franciscan Healthcare
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Terence T. Sio
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Demet Gokalp Yasar
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Demet Gokalp Yasar
Facility Name
ProHealth D N Greenwald Center
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53149
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research.institute@phci.org
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
ProHealth Oconomowoc Memorial Hospital
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-928-7878
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Demet Gokalp Yasar
Facility Name
UW Cancer Center at ProHealth Care
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-928-5539
Email
Chanda.miller@phci.org
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-782-8581
Email
oncology.clinical.trials@marshfieldresearch.org
First Name & Middle Initial & Last Name & Degree
Demet Gokalp Yasar

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
IPD Sharing URL
https://grants.nih.gov/policy/sharing.htm
Citations:
PubMed Identifier
35613998
Citation
Schild SE, Wang X, Bestvina CM, Williams T, Masters G, Singh AK, Stinchcombe TE, Salama JK, Wolf S, Zemla T, Duma N, Chun SG, Amini A, Kozono D, Watt C. Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer. Clin Lung Cancer. 2022 Jul;23(5):e317-e320. doi: 10.1016/j.cllc.2022.04.004. Epub 2022 Apr 30.
Results Reference
derived

Learn more about this trial

Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative

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