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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00544 | Registry Identifier | NCI Clinical Trial Reporting Program | |
| UG1CA189823 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
I. To estimate the adverse event profile of MK-3475 (pembrolizumab) in non-small cell lung cancer patients who are age 70 years of age or older and who are treated with MK-3475 (pembrolizumab) +/- chemotherapy in a first-line setting.
SECONDARY OBJECTIVES:
I. To estimate overall survival. II. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire.
III. To explore whether Comprehensive Geriatric Assessment (CGA) -derived risk score is able to predict rates of severe adverse events in older cancer patients who receive MK-3475 (pembrolizumab) or MK-3475 (pembrolizumab) + chemotherapy.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
GROUP B: Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up annually for up to 5 years after registration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (pembrolizumab) | Experimental | Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Group B (pembrolizumab, pemetrexed, carboplatin) | Experimental | Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade 3 or Worse Adverse Events Post Registration | Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE. | Up to 7 days of last day of treatment, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Will be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort. | From study registration to death or the last follow-up whichever occurs first, assessed up to 3 years |
| Quality of Life (QOL): Linear Analogue Self-Assessment [LASA] Questionnaire |
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Inclusion Criteria:
Documentation of Disease: Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation
Planning to begin MK-3475 (pembrolizumab) treatment within 14 days of registration, with or without combination chemotherapy. Treating physician considers pembrolizumab as appropriate and plans to proceed with one of the following treatment schedules:
Patients will be ineligible if they have an autoimmune disorder, are post-organ transplantation, or are receiving ongoing immunosuppression treatment
Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to registration
No planned radiation or other cancer treatment in the 3 months following registration
No untreated brain metastases. Patients must be off corticosteroids and asymptomatic at registration
Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
Platelet count: >= 100,000/mm^3 (100 x 10^9/L)
Creatinine >= 30 mL/min* for patients enrolled to pembrolizumab alone and > 45 mL/min for patients enrolled to chemotherapy + pembrolizumab
* Calculated using the Cockcroft-Gault formula
Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present) Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | 98508 | United States | ||
| Anchorage Radiation Therapy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42161344 | Derived | Wong ML, Lee MK, Kour O, Satele D, Presley CJ, Le-Rademacher J, Ojelabi M, Chow S, Stinchcombe TE, Homan S, Finnes HD, Waqar S, Jatoi A. Pembrolizumab with or without chemotherapy among older adults with advanced lung adenocarcinoma: a national, nonrandomized open-label phase II trial (Alliance A171901). J Natl Cancer Inst. 2026 May 20:djag157. doi: 10.1093/jnci/djag157. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Pembrolizumab) | Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.>> >> Pembrolizumab: Given IV>> >> Comprehensive Geriatric Assessment: Ancillary studies>> >> Questionnaire Administration: Ancillary studies>> >> Quality-of-Life Assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2022 |
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| Pemetrexed | Drug | Given IV |
|
| Carboplatin | Drug | Given IV |
|
| Comprehensive Geriatric Assessment | Other | Ancillary studies |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
The overall quality of life score (the first question of the Linear Analogue Self-Assessment [LASA] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot. The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method. The overall quality of life score will be measured on a scale from 0-10, with higher being better. |
| Up to 9 weeks |
| Comprehensive Geriatric Assessment Risk Score | The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events. | At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm. |
| Anchorage |
| Alaska |
| 99504 |
| United States |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | 99508 | United States |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | United States |
| Alaska Women's Cancer Care | Anchorage | Alaska | 99508 | United States |
| Anchorage Oncology Centre | Anchorage | Alaska | 99508 | United States |
| Katmai Oncology Group | Anchorage | Alaska | 99508 | United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Fairbanks Memorial Hospital | Fairbanks | Alaska | 99701 | United States |
| Kingman Regional Medical Center | Kingman | Arizona | 86401 | United States |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | 93420 | United States |
| PCR Oncology | Arroyo Grande | California | 93420 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Pacific Central Coast Health Center-San Luis Obispo | San Luis Obispo | California | 93401 | United States |
| Mission Hope Medical Oncology - Santa Maria | Santa Maria | California | 93444 | United States |
| Saint Helena Hospital | St. Helena | California | 94574 | United States |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | United States |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | United States |
| Boulder Community Foothills Hospital | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | United States |
| Rocky Mountain Cancer Centers - Centennial | Centennial | Colorado | 80112 | United States |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | United States |
| National Jewish Health-Main Campus | Denver | Colorado | 80206 | United States |
| The Women's Imaging Center | Denver | Colorado | 80209 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | 80218 | United States |
| SCL Health Saint Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Rose | Denver | Colorado | 80220 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| Western Surgical Care | Denver | Colorado | 80220 | United States |
| Mountain Blue Cancer Care Center - Swedish | Englewood | Colorado | 80113 | United States |
| Rocky Mountain Cancer Centers - Swedish | Englewood | Colorado | 80113 | United States |
| Swedish Medical Center | Englewood | Colorado | 80113 | United States |
| The Melanoma and Skin Cancer Institute | Englewood | Colorado | 80113 | United States |
| National Jewish Health-Western Hematology Oncology | Golden | Colorado | 80401 | United States |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81501 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado | 80228 | United States |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | 80120 | United States |
| Littleton Adventist Hospital | Littleton | Colorado | 80122 | United States |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | United States |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | United States |
| Longmont United Hospital | Longmont | Colorado | 80501 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| Parker Adventist Hospital | Parker | Colorado | 80138 | United States |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | United States |
| National Jewish Health-Northern Hematology Oncology | Thornton | Colorado | 80260 | United States |
| Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado | 80260 | United States |
| SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | United States |
| Beebe South Coastal Health Campus | Frankford | Delaware | 19945 | United States |
| Beebe Medical Center | Lewes | Delaware | 19958 | United States |
| Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | 19713 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware | 19801 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| South Florida Baptist Hospital | Plant City | Florida | 33563 | United States |
| Saint Anthony's Hospital Cancer Care Center | St. Petersburg | Florida | 33705 | United States |
| Moffitt Cancer Center-International Plaza | Tampa | Florida | 33607 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | 33612 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Moffitt Cancer Center at Wesley Chapel | Wesley Chapel | Florida | 33544 | United States |
| Winter Haven Hospital | Winter Haven | Florida | 33881 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | United States |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | United States |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | United States |
| Walter Knox Memorial Hospital | Emmett | Idaho | 83617 | United States |
| Saint Luke's Cancer Institute - Fruitland | Fruitland | Idaho | 83619 | United States |
| Idaho Urologic Institute-Meridian | Meridian | Idaho | 83642 | United States |
| Saint Luke's Cancer Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Saint Luke's Cancer Institute - Nampa | Nampa | Idaho | 83686 | United States |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | 83687 | United States |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | United States |
| Kootenai Cancer Clinic | Sandpoint | Idaho | 83864 | United States |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | United States |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Saint Mary's Hospital | Centralia | Illinois | 62801 | United States |
| Jesse Brown Veterans Affairs Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| Carle at The Riverfront | Danville | Illinois | 61832 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Duly Health and Care Joliet | Joliet | Illinois | 60435 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | United States |
| West Suburban Medical Center | River Forest | Illinois | 60305 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Springfield Clinic | Springfield | Illinois | 62702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| The Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Rush-Copley Healthcare Center | Yorkville | Illinois | 60560 | United States |
| Reid Health | Richmond | Indiana | 47374 | United States |
| Mary Greeley Medical Center | Ames | Iowa | 50010 | United States |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | United States |
| McFarland Clinic - Boone | Boone | Iowa | 50036 | United States |
| Saint Anthony Regional Hospital | Carroll | Iowa | 51401 | United States |
| Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa | 52402 | United States |
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | United States |
| Mercy Cancer Center-West Lakes | Clive | Iowa | 50325 | United States |
| Jennie Edmundson Memorial Hospital | Council Bluffs | Iowa | 51502 | United States |
| Heartland Oncology and Hematology LLP | Council Bluffs | Iowa | 51503 | United States |
| Greater Regional Medical Center | Creston | Iowa | 50801 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | United States |
| Broadlawns Medical Center | Des Moines | Iowa | 50314 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| Mission Cancer and Blood - Laurel | Des Moines | Iowa | 50314 | United States |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| McFarland Clinic - Trinity Cancer Center | Fort Dodge | Iowa | 50501 | United States |
| Trinity Regional Medical Center | Fort Dodge | Iowa | 50501 | United States |
| McFarland Clinic - Jefferson | Jefferson | Iowa | 50129 | United States |
| McFarland Clinic - Marshalltown | Marshalltown | Iowa | 50158 | United States |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | United States |
| Mercy Medical Center-West Lakes | West Des Moines | Iowa | 50266 | United States |
| Ochsner LSU Health Monroe Medical Center | Monroe | Louisiana | 71202 | United States |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70112 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Ochsner LSU Health Saint Mary's Medical Center | Shreveport | Louisiana | 71101 | United States |
| LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | 71103 | United States |
| Harold Alfond Center for Cancer Care | Augusta | Maine | 04330 | United States |
| MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford | Biddeford | Maine | 04005 | United States |
| MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford | Sanford | Maine | 04073 | United States |
| Maine Medical Partners - South Portland | South Portland | Maine | 04106 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Saint Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Northwest Hospital Center | Randallstown | Maryland | 21133 | United States |
| William E Kahlert Regional Cancer Center/Sinai Hospital | Westminster | Maryland | 21157 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Hickman Cancer Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| Saint Joseph Mercy Brighton | Brighton | Michigan | 48114 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | United States |
| Saint Joseph Mercy Canton | Canton | Michigan | 48188 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | United States |
| Saint Joseph Mercy Chelsea | Chelsea | Michigan | 48118 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | United States |
| Hematology Oncology Consultants-Clarkston | Clarkston | Michigan | 48346 | United States |
| Newland Medical Associates-Clarkston | Clarkston | Michigan | 48346 | United States |
| Ascension Saint John Hospital | Detroit | Michigan | 48236 | United States |
| Great Lakes Cancer Management Specialists-Doctors Park | East China Township | Michigan | 48054 | United States |
| Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | 48503 | United States |
| Genesee Hematology Oncology PC | Flint | Michigan | 48503 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | United States |
| Academic Hematology Oncology Specialists | Grosse Pointe Woods | Michigan | 48236 | United States |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Michigan Breast Specialists-Grosse Pointe Woods | Grosse Pointe Woods | Michigan | 48236 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Ascension Borgess Cancer Center | Kalamazoo | Michigan | 49009 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | United States |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Hope Cancer Clinic | Livonia | Michigan | 48154 | United States |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | United States |
| Great Lakes Cancer Management Specialists-Macomb Medical Campus | Macomb | Michigan | 48044 | United States |
| Michigan Breast Specialists-Macomb Township | Macomb | Michigan | 48044 | United States |
| Toledo Clinic Cancer Centers-Monroe | Monroe | Michigan | 48162 | United States |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | United States |
| Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | 49444 | United States |
| Ascension Providence Hospitals - Novi | Novi | Michigan | 48374 | United States |
| 21st Century Oncology-Pontiac | Pontiac | Michigan | 48341 | United States |
| Hope Cancer Center | Pontiac | Michigan | 48341 | United States |
| Newland Medical Associates-Pontiac | Pontiac | Michigan | 48341 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| Spectrum Health Reed City Hospital | Reed City | Michigan | 49677 | United States |
| Ascension Saint Mary's Hospital | Saginaw | Michigan | 48601 | United States |
| Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | 49085 | United States |
| Marie Yeager Cancer Center | Saint Joseph | Michigan | 49085 | United States |
| Ascension Providence Hospitals - Southfield | Southfield | Michigan | 48075 | United States |
| Bhadresh Nayak MD PC-Sterling Heights | Sterling Heights | Michigan | 48312 | United States |
| Advanced Breast Care Center PLLC | Warren | Michigan | 48088 | United States |
| Great Lakes Cancer Management Specialists-Macomb Professional Building | Warren | Michigan | 48093 | United States |
| Macomb Hematology Oncology PC | Warren | Michigan | 48093 | United States |
| Michigan Breast Specialists-Warren | Warren | Michigan | 48093 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Huron Gastroenterology PC | Ypsilanti | Michigan | 48106 | United States |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | United States |
| Riverwood Healthcare Center | Aitkin | Minnesota | 56431 | United States |
| Essentia Health - Baxter Clinic | Baxter | Minnesota | 56425 | United States |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | 56401 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Minnesota Oncology - Burnsville | Burnsville | Minnesota | 55337 | United States |
| Cambridge Medical Center | Cambridge | Minnesota | 55008 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | United States |
| Essentia Health Saint Mary's - Detroit Lakes Clinic | Detroit Lakes | Minnesota | 56501 | United States |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | United States |
| Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | 55805 | United States |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Essentia Health - Ely Clinic | Ely | Minnesota | 55731 | United States |
| Lake Region Healthcare Corporation-Cancer Care | Fergus Falls | Minnesota | 56537 | United States |
| Essentia Health - Fosston | Fosston | Minnesota | 56542 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | United States |
| Essentia Health - International Falls Clinic | International Falls | Minnesota | 56649 | United States |
| Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota | 55369 | United States |
| Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | 55109 | United States |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Health Partners Inc | Minneapolis | Minnesota | 55454 | United States |
| Monticello Cancer Center | Monticello | Minnesota | 55362 | United States |
| Essentia Health - Moose Lake Clinic | Moose Lake | Minnesota | 55767 | United States |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | United States |
| Essentia Health - Park Rapids | Park Rapids | Minnesota | 56470 | United States |
| Fairview Northland Medical Center | Princeton | Minnesota | 55371 | United States |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | United States |
| Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | 55125 | United States |
| Fairview Lakes Medical Center | Wyoming | Minnesota | 55092 | United States |
| Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri | 63011 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| Parkland Health Center - Farmington | Farmington | Missouri | 63640 | United States |
| Freeman Health System | Joplin | Missouri | 64804 | United States |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | United States |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | United States |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Saint Louis Cancer and Breast Institute-South City | St Louis | Missouri | 63109 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Veteran's Affairs Medical Center - Saint Louis | St Louis | Missouri | 63125 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | 63127 | United States |
| Mercy Hospital Washington | Washington | Missouri | 63090 | United States |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Saint Vincent Healthcare | Billings | Montana | 59101 | United States |
| Saint Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | 59701 | United States |
| Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Saint Patrick Hospital - Community Hospital | Missoula | Montana | 59802 | United States |
| Community Medical Hospital | Missoula | Montana | 59804 | United States |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | 68123 | United States |
| CHI Health Saint Francis | Grand Island | Nebraska | 68803 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Oncology Associates PC | Omaha | Nebraska | 68114 | United States |
| Nebraska Medicine-Village Pointe | Omaha | Nebraska | 68118 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Carson Tahoe Regional Medical Center | Carson City | Nevada | 89703 | United States |
| Cancer and Blood Specialists-Henderson | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada | 89052 | United States |
| Las Vegas Cancer Center-Henderson | Henderson | Nevada | 89052 | United States |
| OptumCare Cancer Care at Seven Hills | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada | 89074 | United States |
| GenesisCare USA - Henderson | Henderson | Nevada | 89074 | United States |
| Las Vegas Urology - Green Valley | Henderson | Nevada | 89074 | United States |
| Las Vegas Urology - Pebble | Henderson | Nevada | 89074 | United States |
| Urology Specialists of Nevada - Green Valley | Henderson | Nevada | 89074 | United States |
| Las Vegas Urology - Pecos | Las Vegas | Nevada | 89074 | United States |
| Desert West Surgery | Las Vegas | Nevada | 89102 | United States |
| OptumCare Cancer Care at Charleston | Las Vegas | Nevada | 89102 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| Hope Cancer Care of Nevada | Las Vegas | Nevada | 89103 | United States |
| Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | 89106 | United States |
| Urology Specialists of Nevada - Central | Las Vegas | Nevada | 89106 | United States |
| GenesisCare USA - Las Vegas | Las Vegas | Nevada | 89109 | United States |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | United States |
| Las Vegas Prostate Cancer Center | Las Vegas | Nevada | 89113 | United States |
| Las Vegas Urology - Sunset | Las Vegas | Nevada | 89113 | United States |
| Urology Specialists of Nevada - Southwest | Las Vegas | Nevada | 89113 | United States |
| Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | 89119 | United States |
| Ann M Wierman MD LTD | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | 89128 | United States |
| GenesisCare USA - Vegas Tenaya | Las Vegas | Nevada | 89128 | United States |
| Las Vegas Urology - Cathedral Rock | Las Vegas | Nevada | 89128 | United States |
| Las Vegas Urology - Smoke Ranch | Las Vegas | Nevada | 89128 | United States |
| OptumCare Cancer Care at MountainView | Las Vegas | Nevada | 89128 | United States |
| Urology Specialists of Nevada - Northwest | Las Vegas | Nevada | 89128 | United States |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | United States |
| Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas | Nevada | 89144 | United States |
| Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | 89144 | United States |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | United States |
| Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada | 89148-2405 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| GenesisCare USA - Fort Apache | Las Vegas | Nevada | 89148 | United States |
| OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | 89169 | United States |
| University Cancer Center | Las Vegas | Nevada | 89169 | United States |
| Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada | 89048 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Saint Mary's Regional Medical Center | Reno | Nevada | 89503 | United States |
| Radiation Oncology Associates | Reno | Nevada | 89509 | United States |
| New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | 03301 | United States |
| Solinsky Center for Cancer Care | Manchester | New Hampshire | 03103 | United States |
| Inspira Medical Center Mullica Hill | Mullica Hill | New Jersey | 08062 | United States |
| Hematology Oncology Associates of Central New York-Auburn | Auburn | New York | 13021 | United States |
| Hematology Oncology Associates of Central New York-East Syracuse | East Syracuse | New York | 13057 | United States |
| Glens Falls Hospital | Glens Falls | New York | 12801 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Hematology Oncology Associates of Central New York-Onondaga Hill | Syracuse | New York | 13215 | United States |
| James J Peters VA Medical Center | The Bronx | New York | 10468 | United States |
| South Nassau Cancer Center | Valley Stream | New York | 11580 | United States |
| AdventHealth Infusion Center Asheville | Asheville | North Carolina | 28803 | United States |
| Johnston Health Clayton | Clayton | North Carolina | 27520 | United States |
| Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | 28328 | United States |
| AdventHealth Infusion Center Haywood | Clyde | North Carolina | 28721 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | 27534 | United States |
| Maria Parham Hospital | Henderson | North Carolina | 27536 | United States |
| AdventHealth Hendersonville | Hendersonville | North Carolina | 28792 | United States |
| Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | 28546 | United States |
| Vidant Oncology-Kenansville | Kenansville | North Carolina | 28349 | United States |
| Vidant Oncology-Kinston | Kinston | North Carolina | 28501 | United States |
| Scotland Memorial Hospital-Laurinburg Cancer Center | Laurinburg | North Carolina | 28352 | United States |
| Southeastern Regional Medical Center | Lumberton | North Carolina | 28358 | United States |
| Vidant Oncology-Richlands | Richlands | North Carolina | 28574 | United States |
| Johnston Memorial Hospital | Smithfield | North Carolina | 27577 | United States |
| AdventHealth Infusion Center Weaverville | Weaverville | North Carolina | 28787 | United States |
| Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota | 58103 | United States |
| Essentia Health - Jamestown Clinic | Jamestown | North Dakota | 58401 | United States |
| Indu and Raj Soin Medical Center | Beavercreek | Ohio | 45431 | United States |
| Saint Elizabeth Boardman Hospital | Boardman | Ohio | 44512 | United States |
| Dayton Physicians LLC-Miami Valley South | Centerville | Ohio | 45459 | United States |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio | 45236 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Mount Carmel East Hospital | Columbus | Ohio | 43213 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Grant Medical Center | Columbus | Ohio | 43215 | United States |
| The Mark H Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | United States |
| Doctors Hospital | Columbus | Ohio | 43228 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Dayton Physician LLC-Miami Valley Hospital North | Dayton | Ohio | 45415 | United States |
| Miami Valley Hospital North | Dayton | Ohio | 45415 | United States |
| Delaware Health Center-Grady Cancer Center | Delaware | Ohio | 43015 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Armes Family Cancer Center | Findlay | Ohio | 45840 | United States |
| Blanchard Valley Hospital | Findlay | Ohio | 45840 | United States |
| Orion Cancer Care | Findlay | Ohio | 45840 | United States |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Dayton Physicians LLC-Atrium | Franklin | Ohio | 45005 | United States |
| Dayton Physicians LLC-Wayne | Greenville | Ohio | 45331 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Mount Carmel Grove City Hospital | Grove City | Ohio | 43123 | United States |
| Zangmeister Center Grove City | Grove City | Ohio | 43123 | United States |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio | 43537 | United States |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | United States |
| Mount Carmel New Albany Surgical Hospital | New Albany | Ohio | 43054 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Springfield Regional Cancer Center | Springfield | Ohio | 45504 | United States |
| Springfield Regional Medical Center | Springfield | Ohio | 45505 | United States |
| Saint Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Mercy Health - Saint Anne Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | 43623 | United States |
| Dayton Physicians LLC - Troy | Troy | Ohio | 45373 | United States |
| Upper Valley Medical Center | Troy | Ohio | 45373 | United States |
| Saint Joseph Warren Hospital | Warren | Ohio | 44484 | United States |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | United States |
| Wright-Patterson Medical Center | Wright-Patterson Air Force Base | Ohio | 45433 | United States |
| Saint Elizabeth Youngstown Hospital | Youngstown | Ohio | 44501 | United States |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | United States |
| Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | 73120 | United States |
| Saint Alphonsus Medical Center-Baker City | Baker City | Oregon | 97814 | United States |
| Good Samaritan Hospital | Corvallis | Oregon | 97330 | United States |
| Saint Alphonsus Medical Center-Ontario | Ontario | Oregon | 97914 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | United States |
| Chambersburg Hospital | Chambersburg | Pennsylvania | 17201 | United States |
| WellSpan Medical Oncology and Hematology | Chambersburg | Pennsylvania | 17201 | United States |
| Main Line Health Center-Collegeville | Collegeville | Pennsylvania | 19426 | United States |
| Ephrata Cancer Center | Ephrata | Pennsylvania | 17522 | United States |
| Ephrata Community Hospital | Ephrata | Pennsylvania | 17522 | United States |
| Main Line Health Center-Exton | Exton | Pennsylvania | 19341 | United States |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Cherry Tree Cancer Center | Hanover | Pennsylvania | 17331 | United States |
| Sechler Family Cancer Center | Lebanon | Pennsylvania | 17042 | United States |
| Riddle Memorial Hospital | Media | Pennsylvania | 19063 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | 19114 | United States |
| Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Cancer Care Associates of York | York | Pennsylvania | 17403 | United States |
| WellSpan Health-York Cancer Center | York | Pennsylvania | 17403 | United States |
| WellSpan Health-York Hospital | York | Pennsylvania | 17403 | United States |
| Kent Hospital | Warwick | Rhode Island | 02886 | United States |
| Saint Joseph's/Candler - Bluffton Campus | Bluffton | South Carolina | 29910 | United States |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | United States |
| Prisma Health Cancer Institute - Easley | Easley | South Carolina | 29640 | United States |
| Tidelands Georgetown Memorial Hospital | Georgetown | South Carolina | 29440 | United States |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | United States |
| South Carolina Cancer Specialists PC | Hilton Head Island | South Carolina | 29926-3827 | United States |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| Saint Joseph Regional Cancer Center | Bryan | Texas | 77802 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Cancer Specialists of Tidewater Limited | Chesapeake | Virginia | 23320 | United States |
| Peninsula Cancer Institute-Gloucester | Gloucester | Virginia | 23061 | United States |
| Centra Lynchburg Hematology-Oncology Clinic Inc | Lynchburg | Virginia | 24501 | United States |
| Bon Secours Memorial Regional Medical Center | Mechanicsville | Virginia | 23116 | United States |
| Bon Secours Westchester Emergency Center | Midlothian | Virginia | 23113 | United States |
| Bon Secours Saint Francis Medical Center | Midlothian | Virginia | 23114 | United States |
| Peninsula Cancer Institute-Newport News | Newport News | Virginia | 23601 | United States |
| Bon Secours DePaul Medical Center | Norfolk | Virginia | 23505 | United States |
| Riverside Shore Cancer Center | Onancock | Virginia | 23417 | United States |
| Bon Secours Maryview Medical Center | Portsmouth | Virginia | 23707 | United States |
| Bon Secours Saint Mary's Hospital | Richmond | Virginia | 23226 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23229 | United States |
| Bon Secours Cancer Institute at Reynolds Crossing | Richmond | Virginia | 23230 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| VCU Community Memorial Health Center | South Hill | Virginia | 23970 | United States |
| Bon Secours Health Center at Harbour View | Suffolk | Virginia | 23435 | United States |
| Cancer Specialists of Tidewater-Suffolk | Suffolk | Virginia | 23435 | United States |
| Peninsula Cancer Institute-Cancer Specialists of Tidewater | Virginia Beach | Virginia | 23454 | United States |
| Peninsula Cancer Institute-Williamsburg | Williamsburg | Virginia | 23185 | United States |
| Overlake Medical Center | Bellevue | Washington | 98004 | United States |
| Swedish Cancer Institute-Edmonds | Edmonds | Washington | 98026 | United States |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Jefferson Healthcare | Port Townsend | Washington | 98368 | United States |
| Valley Medical Center | Renton | Washington | 98055 | United States |
| Swedish Medical Center-Ballard Campus | Seattle | Washington | 98107 | United States |
| Swedish Medical Center-Cherry Hill | Seattle | Washington | 98122-5711 | United States |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122 | United States |
| Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | United States |
| United Hospital Center | Bridgeport | West Virginia | 26330 | United States |
| WVUH-Berkely Medical Center | Martinsburg | West Virginia | 25401 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| Camden Clark Medical Center | Parkersburg | West Virginia | 26101 | United States |
| Wheeling Hospital/Schiffler Cancer Center | Wheeling | West Virginia | 26003 | United States |
| Duluth Clinic Ashland | Ashland | Wisconsin | 54806 | United States |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | 54806 | United States |
| Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | 54729 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Mayo Clinic Health System-Eau Claire Clinic | Eau Claire | Wisconsin | 54701 | United States |
| Essentia Health-Hayward Clinic | Hayward | Wisconsin | 54843 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| Marshfield Clinic - Ladysmith Center | Ladysmith | Wisconsin | 54848 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| ProHealth D N Greenwald Center | Mukwonago | Wisconsin | 53149 | United States |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Drexel Town Square Health Center | Oak Creek | Wisconsin | 53154 | United States |
| ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | United States |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | United States |
| Essentia Health-Spooner Clinic | Spooner | Wisconsin | 54801 | United States |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | United States |
| Essentia Health Saint Mary's Hospital - Superior | Superior | Wisconsin | 54880 | United States |
| ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | United States |
| Marshfield Clinic-Wausau Center | Wausau | Wisconsin | 54401 | United States |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | 53095 | United States |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Cheyenne Regional Medical Center-West | Cheyenne | Wyoming | 82001 | United States |
| Billings Clinic-Cody | Cody | Wyoming | 82414 | United States |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | United States |
| FG001 | Group B (Pembrolizumab, Pemetrexed, Carboplatin) | Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.>> >> Pembrolizumab: Given IV>> >> Pemetrexed: Given IV>> >> Carboplatin: Given IV>> >> Comprehensive Geriatric Assessment: Ancillary studies>> >> Questionnaire Administration: Ancillary studies>> >> Quality-of-Life Assessment: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Pembrolizumab) | Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.>> >> Pembrolizumab: Given IV>> >> Comprehensive Geriatric Assessment: Ancillary studies>> >> Questionnaire Administration: Ancillary studies>> >> Quality-of-Life Assessment: Ancillary studies |
| BG001 | Group B (Pembrolizumab, Pemetrexed, Carboplatin) | Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.>> >> Pembrolizumab: Given IV>> >> Pemetrexed: Given IV>> >> Carboplatin: Given IV>> >> Comprehensive Geriatric Assessment: Ancillary studies>> >> Questionnaire Administration: Ancillary studies>> >> Quality-of-Life Assessment: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction.> ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.> ECOG = 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.> ECOG = 0 is better. ECOG = 3 is worse. | Count of Participants | Participants |
| |||||||||||||||
| Concomitant Chemo | Count of Participants | Participants |
| ||||||||||||||||
| Prior Adjuvant Chemo | Count of Participants | Participants |
| ||||||||||||||||
| Prior Radiotherapy | Count of Participants | Participants |
| ||||||||||||||||
| Any Prior Cancer Diagnosed | Count of Participants | Participants |
| ||||||||||||||||
| Cancer Treatment started prior to enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Smoking History | Count of Participants | Participants |
| ||||||||||||||||
| PD-L1 Expression | Mean | Standard Deviation | Tumor Proportion Score (%) |
| |||||||||||||||
| Diagnosis of Non-Small Cell Lung Cancer | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Grade 3 or Worse Adverse Events Post Registration | Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE. | Posted | Count of Participants | Participants | Up to 7 days of last day of treatment, up to 6 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Will be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort. | Posted | Median | 95% Confidence Interval | months | From study registration to death or the last follow-up whichever occurs first, assessed up to 3 years |
| |||||||||||||||||||||||||||||||
| Secondary | Quality of Life (QOL): Linear Analogue Self-Assessment [LASA] Questionnaire | The overall quality of life score (the first question of the Linear Analogue Self-Assessment [LASA] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot. The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method. The overall quality of life score will be measured on a scale from 0-10, with higher being better. | There were 60 patients who had QOL change from baseline to week 9. Per the protocol section 13.5, quality of life would be examined combined by arm. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 9 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Comprehensive Geriatric Assessment Risk Score | The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events. | Analyzed with both arms combined | Posted | Count of Participants | Participants | At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm. |
|
|
Up to 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Pembrolizumab) | Quality-of-Life Assessment: Ancillary studies | 8 | 43 | 8 | 43 | 43 | 43 |
| EG001 | Group B (Pembrolizumab, Pemetrexed, Carboplatin) | Quality-of-Life Assessment: Ancillary studies | 6 | 54 | 6 | 54 | 53 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart failure | Cardiac disorders | CTCAE 5 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Disease progression | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Neoplasms benign, mal, uncpec - Oth spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 5 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 5 | Systematic Assessment |
| |
| Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | CTCAE 5 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE 5 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE 5 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE 5 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE 5 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE 5 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE 5 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE 5 | Systematic Assessment |
| |
| Ear and labyrinth disorders - Oth spec | Ear and labyrinth disorders | CTCAE 5 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE 5 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE 5 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE 5 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE 5 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE 5 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE 5 | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE 5 | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE 5 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE 5 | Systematic Assessment |
| |
| Flashing lights | Eye disorders | CTCAE 5 | Systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE 5 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Belching | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Facial pain | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Gen disord and admin site conds-Oth spec | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Generalized edema | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE 5 | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE 5 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE 5 | Systematic Assessment |
| |
| Infections and infestations - Oth spec | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE 5 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Inj, pois and proced complic - Oth spec | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Thyroid stimulating hormone increased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 5 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hyperlipidemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Neoplasms benign, mal, uncpec - Oth spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 5 | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 5 | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Muscle weakness left-sided | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Muscle weakness right-sided | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE 5 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 5 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE 5 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE 5 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 5 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE 5 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | CTCAE 5 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Dysuria (painful urination) | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Renal and urinary disorders - Oth spec | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE 5 | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE 5 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Resp, thoracic, mediastinal - Oth spec | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE 5 | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE 5 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 5 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE 5 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE 5 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE 5 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aminah Jatoi | Mayo Clinic | 507-266-9160 | Jatoi.Aminah@mayo.edu |
| Oct 17, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| 3 |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Stage IV |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Low Risk Group |
| |||||
| Medium Risk Group |
| |||||
| High Risk Group |
|
|