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| ID | Type | Description | Link |
|---|---|---|---|
| CA248-0001 | Other Identifier | Bristol-Myers Squibb Protocol ID | |
| 516-005 | Other Identifier | Mirati Therapeutics Protocol ID |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
Sitravatinib (MGCD516) is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs) including MET, TAM (Tyro3, AXL, MERTK) family, VEGFR family, PDGFR family, KIT, FLT3, TRK family, RET, DDR2, and selected EPH family members. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab and Sitravatinib | Experimental | Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily. |
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| Docetaxel | Active Comparator | Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as time from date of randomization to date of death due to any cause. Patients who did not die on study are censored at the date of the last on-study follow-up that the patient was known to be alive (including follow-up data). Results obtained via Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method. | From randomization date to date of death due to any cause (Up to approximately 44 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Event (TEAEs) | An adverse event (AE) is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any preexisting condition that increases in severity after the first dose of study treatment. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 005-164 | Birmingham | Alabama | 35243 | United States | ||
| Clearview Cancer Institute - Huntsville |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab and Sitravatinib | Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Nivolumab by intravenous infusion over 30 minutes at 240 milligram (mg) every 2 weeks or at 480 mg every 4 weeks at the discretion of the investigator . Sitravatinib capsules were administered at 100 mg orally, once daily. |
| 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 | Oct 7, 2021 |
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| Sitravatinib | Drug | Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases. |
|
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| Docetaxel | Drug | Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells. |
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| From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation | An adverse event (AE) is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. A treatment emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any preexisting condition that increases in severity after the first dose of study treatment. | From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months) |
| Number of Participants With Maximum Post Baseline Hematology Grade Results | The severity of hematology results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death. Number of participants with maximum post baseline grades is presented. Grade 0 is defined as absence of an AE or within normal limits. Baseline is defined as the last pre-dose assessment. | From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months) |
| Number of Participants With Maximum Post Baseline Chemistry Grade Results | The severity of chemistry results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Chemistry parameters were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death. Number of participants with maximum post baseline grades is presented. Grade 0 is defined as absence of an AE or within normal limits. Baseline is defined as the last pre-dose assessment. | From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months) |
| Objective Response Rate (ORR) Per Central Radiographic Assessment | ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. Patients who cannot be assessed for response are counted as non-responders. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. | From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months) |
| Duration of Response (DOR) Per Central Radiographic Assessment | DOR is defined as the time from date of the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions. Results obtained via Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method. | From randomization to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD (Up to approximately 44 months) |
| Clinical Benefit Rate Per Central Radiographic Assessment | CBR is defined as the percentage of patients documented to have a confirmed CR, confirmed PR, or SD, according to RECIST 1.1 as the best response. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. | From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months) |
| Progression-Free Survival (PFS) Per Central Radiographic Assessment | PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions. Censoring was assigned on the date of the last tumor assessment if no assessment of tumor progression is identified and the patient does not die while on study. Patients with no evaluation of disease after first study treatment will have PFS censored on the date of randomization. Patients who start new anti-cancer therapy prior to documented PD will be censored at the date of the last tumor assessment prior to the start of the new therapy. Results obtained using Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method. | From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 44 months) |
| 1-Year Survival Rate | 1-Year Survival will be defined as the percentage of participants surviving at 1 year after the first dose. Results obtained via Kaplan-Meier estimation, Greenwood's formula (1980). | At 12 months from first dose |
| Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score | The LCSS is a lung cancer specific measure of quality of life and includes 9 questions, including patient-reported ratings of six symptoms (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and three summary items (symptom distress, activity level, overall quality of life) using 100-mm visual analogue scales ranging from 0 (lowest rating) to 100 (highest rating). The average total score = is a sum of items 1 to 9 divided by the total number of items (sum of items 1 to 9) / 9). | Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49. |
| Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. | Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49. |
| Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) | The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points. | Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49. |
| Sitravatinib Plasma Concentration by Time Point | 0.5 hours post dose on cycle 1 (day 1) and 5 hours post dose on cycle 1 (day 1 and 15), and pre-dose on cycle 1 (day 15), and cycle 2, 3, and 5 (day 1) |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| Palo Verde Cancer Specialists - Glendale | Glendale | Arizona | 85304 | United States |
| The Oncology Institute of Hope & Innovation - Tucson | Tucson | Arizona | 85745 | United States |
| Yuma Regional Medical Center | Yuma | Arizona | 85364 | United States |
| Local Institution - 005-174 | Jonesboro | Arkansas | 72401 | United States |
| NEA Baptist Fowler Family Center for Cancer Care | Jonesboro | Arkansas | 72401 | United States |
| Highlands Oncology Group - Springdale | Springdale | Arkansas | 72762 | United States |
| Comprehensive Blood and Cancer Center - Bakersfield | Bakersfield | California | 93309 | United States |
| Local Institution - 005-118 | Beverly Hills | California | 90211 | United States |
| Local Institution - 005-171 | Fresno | California | 93720 | United States |
| Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton | Fullerton | California | 92835 | United States |
| Local Institution - 005-096 | Long Beach | California | 90813 | United States |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | United States |
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | 90017 | United States |
| Local Institution - 005-185 | Los Angeles | California | 90095 | United States |
| Local Institution - 005-072 | Newport Beach | California | 92663 | United States |
| Local Institution - 005-109 | Northridge | California | 91325 | United States |
| Local Institution - 005-177 | Redlands | California | 92373 | United States |
| Local Institution - 005-112 | Riverside | California | 92501 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Local Institution - 005-176 | San Marcos | California | 92069 | United States |
| Local Institution - 005-192 | Torrance | California | 90505 | United States |
| Local Institution - 005-090 | West Covina | California | 91790 | United States |
| Local Institution - 005-105 | Whittier | California | 90602 | United States |
| Local Institution - 005-097 | Lafayette | Colorado | 80026 | United States |
| Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | 33308 | United States |
| Local Institution - 005-120 | Fort Myers | Florida | 33901 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Watson Clinic Cancer and Research Center | Lakeland | Florida | 33805 | United States |
| Mount Sinai Health System | Miami Beach | Florida | 33140 | United States |
| Local Institution - 005-120E | Naples | Florida | 34102 | United States |
| Local Institution - 005-079 | Ocala | Florida | 34474 | United States |
| Local Institution - 005-104 | Orlando | Florida | 32804 | United States |
| SCRI - Florida Cancer Specialists - North Region Research Office | St. Petersburg | Florida | 33705 | United States |
| SCRI - Florida Cancer Specialists - Panhandle Research Office | Tallahassee | Florida | 32308 | United States |
| Local Institution - 005-154 | West Palm Beach | Florida | 33401 | United States |
| University Cancer & Blood Center (UCBC) - Athens | Athens | Georgia | 30607 | United States |
| Local Institution - 005-146 | Atlanta | Georgia | 30318 | United States |
| John B. Amos Cancer Center Research | Columbus | Georgia | 31904 | United States |
| Local Institution - 005-119 | Marietta | Georgia | 30060 | United States |
| Straub Medical Center | Honolulu | Hawaii | 96813 | United States |
| Local Institution - 005-191 | Coeur d'Alene | Idaho | 83814 | United States |
| Local Institution - 005-151 | Chicago | Illinois | 60625-3645 | United States |
| Local Institution - 005-110 | Evanston | Illinois | 60201 | United States |
| Local Institution - 005-198 | Niles | Illinois | 60714 | United States |
| Orchard Healthcare Research | Skokie | Illinois | 60077 | United States |
| Healthcare Research Network - Tinley Park | Tinley Park | Illinois | 60487 | United States |
| Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office | Fort Wayne | Indiana | 46804 | United States |
| Local Institution - 005-122 | Goshen | Indiana | 46526 | United States |
| Franciscan Health Cancer Center Indianapolis | Indianapolis | Indiana | 46237 | United States |
| Local Institution - 005-150 | Lafayette | Indiana | 47904 | United States |
| Local Institution - 005-169 | Westwood | Kansas | 66205 | United States |
| Local Institution - 005-098 | Wichita | Kansas | 67214 | United States |
| Commonwealth Cancer Center - Frankfort | Danville | Kentucky | 40422 | United States |
| Local Institution - 005-153 | Louisville | Kentucky | 40241 | United States |
| New England Cancer Specialists - Scarborough | Scarborough | Maine | 04074 | United States |
| Local Institution - 005-178 | Rockville | Maryland | 20850-6535 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Local Institution - 005-127 | Minneapolis | Minnesota | 55404 | United States |
| Local Institution - 005-159 | Saint Louis Park | Minnesota | 55426-5000 | United States |
| Jackson Oncology Associates - The Hederman Cancer Center | Jackson | Mississippi | 39202 | United States |
| Central Care Cancer Center - Bolivar | Bolivar | Missouri | 65613 | United States |
| Kansas City Care Health Center - Research Medical Campus | Kansas City | Missouri | 64132 | United States |
| Sisters of Charity of Leavenworth Health St. Marys | Billings | Montana | 59102 | United States |
| Saint Francis Cancer Treatment Center | Grand Island | Nebraska | 68803 | United States |
| Methodist Hospital - Omaha | Omaha | Nebraska | 68114 | United States |
| The Oncology Institute of Hope & Innovation - Henderson | Henderson | Nevada | 89052 | United States |
| Local Institution - 005-152 | Henderson | Nevada | 89074 | United States |
| Local Institution - 005-142 | Florham Park | New Jersey | 07932 | United States |
| Local Institution - 005-163 | Little Silver | New Jersey | 07739 | United States |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Regional Cancer Care Associates - Sparta | Sparta | New Jersey | 07871 | United States |
| Local Institution - 005-123 | Johnson City | New York | 13790 | United States |
| Local Institution - 005-182 | Lake Success | New York | 11042 | United States |
| New York Cancer & Blood Specialists - Port Jefferson Medical Oncology | Port Jefferson Station | New York | 11776 | United States |
| Local Institution - 005-107 | Stony Brook | New York | 11794 | United States |
| Local Institution - 005-196 | Canton | Ohio | 44708 | United States |
| USOR - Oncology Hematology Care - Blue Ash | Cincinnati | Ohio | 45242 | United States |
| Local Institution - 005-181 | Columbus | Ohio | 43210 | United States |
| Tricounty Hematology and Oncology - Massillon | Massillon | Ohio | 44646 | United States |
| Local Institution - 005-103 | Toledo | Ohio | 43623 | United States |
| Local Institution - 005-088 | Oklahoma City | Oklahoma | 73120 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Local Institution - 005-073 | Portland | Oregon | 97239 | United States |
| USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates) | Horsham | Pennsylvania | 19044 | United States |
| Local Institution - 005-186 | Philadelphia | Pennsylvania | 19111 | United States |
| Local Institution - 005-137A | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137B | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137C | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137D | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137E | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137F | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137G | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137H | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137I | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137J | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137K | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137L | Dickson | Tennessee | 37055 | United States |
| Local Institution - 005-137M | Hendersonville | Tennessee | 37075 | United States |
| Local Institution - 005-195 | Memphis | Tennessee | 38120 | United States |
| Local Institution - 005-137 | Nashville | Tennessee | 37203 | United States |
| Local Institution - 005-134 | Austin | Texas | 78745 | United States |
| Local Institution - 005-075 | Beaumont | Texas | 77702 | United States |
| Local Institution - 005-128 | Dallas | Texas | 75203 | United States |
| Local Institution - 005-129 | Dallas | Texas | 75231 | United States |
| Local Institution - 005-126 | Dallas | Texas | 75246 | United States |
| USOR - Texas Oncology Northeast Texas - Denison | Denison | Texas | 75020 | United States |
| Local Institution - 005-124 | Denton | Texas | 76201 | United States |
| The Center for Cancer & Blood Disorders - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Oncology Consultants - Texas Medical Center | Houston | Texas | 77030 | United States |
| Local Institution - 005-076 | Houston | Texas | 77070 | United States |
| Millennium Research and Clinical Development | Houston | Texas | 77090 | United States |
| USOR - US Oncology Investigational Products Center | Irving | Texas | 75063 | United States |
| Local Institution - 005-125 | McKinney | Texas | 75071 | United States |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | United States |
| USOR - Texas Oncology - Sugar Land | Sugar Land | Texas | 77479 | United States |
| USOR - Texas Oncology Northeast Texas - Cancer and Research Institute - Tyler | Tyler | Texas | 75702 | United States |
| Local Institution - 005-144 | Charlottesville | Virginia | 22903 | United States |
| Hematology Oncology Associates of Fredericksburg | Fredericksburg | Virginia | 24408 | United States |
| Virginia Cancer Institute - West End | Richmond | Virginia | 23229 | United States |
| Overlake Medical Center and Clinics | Bellevue | Washington | 98004 | United States |
| Local Institution - 005-082 | Everett | Washington | 98201 | United States |
| Local Institution - 005-111 | Seattle | Washington | 98109--1023 | United States |
| Local Institution - 005-187 | Spokane | Washington | 99218 | United States |
| Local Institution - 005-081 | Tacoma | Washington | 98405 | United States |
| Northwest Medical Specialties - Tacoma | Tacoma | Washington | 98405 | United States |
| Local Institution - 005-136 | Vancouver | Washington | 98684 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| Local Institution - 005-116 | Madison | Wisconsin | 53792 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution - 005-201 | Brasschaat | 2930 | Belgium |
| Local Institution - 005-200 | Charleroi | 6000 | Belgium |
| Local Institution - 005-206 | Edegem | 2650 | Belgium |
| Local Institution - 005-202 | Ghent | 9000 | Belgium |
| Local Institution - 005-207 | Ghent | 9000 | Belgium |
| Local Institution - 005-205 | Roeselare | 8800 | Belgium |
| Local Institution - 005-204 | Ronse | 9600 | Belgium |
| Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne | Yvoir | B-5530 | Belgium |
| Local Institution - 005-259 | Calgary | Alberta | T2N 4N2 | Canada |
| Local Institution - 005-250 | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Local Institution - 005-252 | Hamilton | Ontario | L8V 5C2 | Canada |
| Local Institution - 005-251 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 005-257 | Windsor | Ontario | N8W 2X3 | Canada |
| Local Institution - 005-255 | Montreal | Quebec | H3A 0G4 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Local Institution - 005-258 | Québec | G1V 4G5 | Canada |
| Local Institution - 005-307 | Brest | 29200 | France |
| Local Institution - 005-310 | Bron | 69500 | France |
| Local Institution - 005-311 | Créteil | 94000 | France |
| Local Institution - 005-303 | Dijon | 21079 | France |
| Local Institution - 005-309 | Le Mans | 72037 | France |
| Local Institution - 005-308 | Limoges | 87042 | France |
| Local Institution - 005-317 | Lyon | 69008 | France |
| Local Institution - 005-301 | Marseille | 13009 | France |
| Local Institution - 005-312 | Marseille | 13015 | France |
| Local Institution - 005-313 | Montpellier | 34298 | France |
| Local Institution - 005-306 | Mulhouse | 68100 | France |
| Local Institution - 005-302 | Paris | 75018 | France |
| Local Institution - 005-314 | Rouen | 76031 | France |
| Local Institution - 005-316 | Saint-Herblain | 44805 | France |
| Local Institution - 005-305 | Strasbourg | 67200 | France |
| Local Institution - 005-304 | Villejuif | 94805 | France |
| Local Institution - 005-400 | Bad Berka | 99437 | Germany |
| Local Institution - 005-418 | Berlin | 13125 | Germany |
| Local Institution - 005-401 | Bonn | 53127 | Germany |
| Local Institution - 005-412 | Cologne | 51109 | Germany |
| Local Institution - 005-419 | Essen | 45136 | Germany |
| Local Institution - 005-406 | Esslingen am Neckar | 73730 | Germany |
| Local Institution - 005-403 | Gauting | 82131 | Germany |
| Local Institution - 005-417 | Grohansdorf | 22927 | Germany |
| Local Institution - 005-408 | Halle | 06120 | Germany |
| Local Institution - 005-411 | Immenstadt im Allgäu | 87509 | Germany |
| Local Institution - 005-416 | Kassel | 34125 | Germany |
| Local Institution - 005-410 | Löwenstein | 74245 | Germany |
| Local Institution - 005-405 | Lübeck | 23538 | Germany |
| Local Institution - 005-414 | Mainz | 55131 | Germany |
| Local Institution - 005-413 | München | 81675 | Germany |
| Local Institution - 005-402 | München | 81925 | Germany |
| Local Institution - 005-454 | Budapest | 1083 | Hungary |
| Local Institution - 005-457 | Budapest | 1121 | Hungary |
| Local Institution - 005-455 | Budapest | 1122 | Hungary |
| Local Institution - 005-453 | Farkasgyepű | 8582 | Hungary |
| Local Institution - 005-452 | Győr | 9023 | Hungary |
| Local Institution - 005-451 | Szombathely | 9700 | Hungary |
| Local Institution - 005-450 | Tatabánya | 2800 | Hungary |
| Local Institution - 005-456 | Törökbálint | 2045 | Hungary |
| Local Institution - 005-500 | Afula | 1834111 | Israel |
| Local Institution - 005-501 | Beer Yaakov | 7030000 | Israel |
| Local Institution - 005-504 | Beersheba | 84101 | Israel |
| Local Institution - 005-502 | Holon | 5822012 | Israel |
| Local Institution - 005-507 | Jerusalem | 9103102 | Israel |
| Local Institution - 005-506 | Ramat Gan | 5265601 | Israel |
| Local Institution - 005-505 | Zsfat | 1311001 | Israel |
| Local Institution - 005-612 | Alessandria | 15121 | Italy |
| Local Institution - 005-602 | Bari | 70124 | Italy |
| Local Institution - 005-603 | Catania | 95123 | Italy |
| Local Institution - 005-611 | Cremona | 26100 | Italy |
| Local Institution - 005-608 | Lecce | 73100 | Italy |
| Local Institution - 005-610 | Meldola | 47014 | Italy |
| Local Institution - 005-606 | Milan | 20141 | Italy |
| Local Institution - 005-605 | Monza | 20900 | Italy |
| Local Institution - 005-604 | Naples | 80131 | Italy |
| Local Institution - 005-600 | Parma | 43126 | Italy |
| Local Institution - 005-607 | Piacenza | 29100 | Italy |
| Local Institution - 005-609 | Pisa | 56126 | Italy |
| Local Institution - 005-614 | Roma | 00144 | Italy |
| Ospedale di Circolo e Fondazione Macchi | Varese | 21100 | Italy |
| Local Institution - 005-700 | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Local Institution - 005-703 | Amsterdam | 1066 CX | Netherlands |
| Local Institution - 005-711 | Amsterdam | 1081 HV | Netherlands |
| Local Institution - 005-707 | Breda | 4818 CK | Netherlands |
| Local Institution - 005-713 | Dordrecht | 3318 AT | Netherlands |
| Local Institution - 005-702 | Groningen | 9728 NT | Netherlands |
| Local Institution - 005-712 | Maastricht | 6229 HX | Netherlands |
| Local Institution - 005-714 | Nijmegen | 6525 GA | Netherlands |
| Local Institution - 005-710 | Rotterdam | 3015 GD | Netherlands |
| Local Institution - 005-705 | Rotterdam | 3045 PM | Netherlands |
| Local Institution - 005-709 | The Hague | 2545 AA | Netherlands |
| Local Institution - 005-701 | Utrecht | 3543 AZ | Netherlands |
| Local Institution - 005-708 | Utrecht | 3584 CX | Netherlands |
| Local Institution - 005-706 | Zwolle | 8025 AB | Netherlands |
| Local Institution - 005-807 | A Coruña | 15006 | Spain |
| Local Institution - 005-800 | Badalona | 08916 | Spain |
| Local Institution - 005-822 | Barcelona | 08003 | Spain |
| Local Institution - 005-811 | Barcelona | 08028 | Spain |
| Local Institution - 005-810 | Barcelona | 08035 | Spain |
| Local Institution - 005-805 | Jaén | 23007 | Spain |
| Local Institution - 005-816 | Las Palmas de Gran Canaria | 35016 | Spain |
| Local Institution - 005-817 | León | 24071 | Spain |
| Local Institution - 005-812 | Lugo | 27003 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Local Institution - 005-808 | Madrid | 28006 | Spain |
| Local Institution - 005-819 | Madrid | 28027 | Spain |
| Local Institution - 005-821 | Madrid | 28034 | Spain |
| Local Institution - 005-813 | Madrid | 28040 | Spain |
| Local Institution - 005-815 | Madrid | 28040 | Spain |
| Local Institution - 005-809 | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Local Institution - 005-806 | Majadahonda | 28222 | Spain |
| Local Institution - 005-801 | Málaga | 29009 | Spain |
| Local Institution - 005-803 | Oviedo | 33011 | Spain |
| Local Institution - 005-823 | Santiago de Compostela | 15706 | Spain |
| IVO - Fundacion Instituto Valenciano de Oncologia | Valencia | 46009 | Spain |
| Local Institution - 005-804 | Valencia | 46026 | Spain |
| Local Institution - 005-818 | Vigo | 36312 | Spain |
| Inselspital Universitatsspital Bern | Bern | 3010 | Switzerland |
| Hopitaux Universitaires de Geneve | Geneva | 1205 | Switzerland |
| Centre Hospitalier Universitaire Vaudois Lausanne | Lausanne | 1011 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
| Velindre University NHS Trust | Cardiff | CF14 2TL | United Kingdom |
| Local Institution - 005-904 | Cornwall | TR1 3LJ | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | LE1 5WW | United Kingdom |
| Local Institution - 005-908 | London | NW3 2QG | United Kingdom |
| Local Institution - 005-900 | London | SW3 6JJ | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Local Institution - 005-903 | Middlesex | HA6 2RN | United Kingdom |
| FG001 |
| Docetaxel |
Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks. |
|
| Safety Population | The Safety Population is defined as all patients who received any dose of study medication (i.e., sitravatinib, nivolumab or docetaxel). |
|
| COMPLETED | Continuing in the study. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab and Sitravatinib | Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Nivolumab by intravenous infusion over 30 minutes at 240 milligram (mg) every 2 weeks or at 480 mg every 4 weeks at the discretion of the investigator . Sitravatinib capsules were administered at 100 mg orally, once daily. |
| BG001 | Docetaxel | Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks. |
| 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/Ethnicity, Customized | 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 | Overall Survival (OS) | OS is defined as time from date of randomization to date of death due to any cause. Patients who did not die on study are censored at the date of the last on-study follow-up that the patient was known to be alive (including follow-up data). Results obtained via Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method. | Intent-to-Treat population: all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From randomization date to date of death due to any cause (Up to approximately 44 months) |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Event (TEAEs) | An adverse event (AE) is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any preexisting condition that increases in severity after the first dose of study treatment. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death). | Safety Population: all patients who received any dose of study medication (i.e., sitravatinib, nivolumab or docetaxel) | Posted | Count of Participants | Participants | From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation | An adverse event (AE) is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. A treatment emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any preexisting condition that increases in severity after the first dose of study treatment. | Safety Population: all patients who received any dose of study medication (i.e., sitravatinib, nivolumab or docetaxel) | Posted | Count of Participants | Participants | From first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months) |
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| Secondary | Number of Participants With Maximum Post Baseline Hematology Grade Results | The severity of hematology results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death. Number of participants with maximum post baseline grades is presented. Grade 0 is defined as absence of an AE or within normal limits. Baseline is defined as the last pre-dose assessment. | Safety Population (all patients who received any dose of study medication) with at least 1 post-baseline result | Posted | Count of Participants | Participants | From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Post Baseline Chemistry Grade Results | The severity of chemistry results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Chemistry parameters were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death. Number of participants with maximum post baseline grades is presented. Grade 0 is defined as absence of an AE or within normal limits. Baseline is defined as the last pre-dose assessment. | Safety Population (all patients who received any dose of study medication) with at least 1 post-baseline result | Posted | Count of Participants | Participants | From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per Central Radiographic Assessment | ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. Patients who cannot be assessed for response are counted as non-responders. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. | The Modified Intent-to-Treat Population: all patients who are randomized into this study and have measurable disease (per RECIST 1.1) at baseline per central radiographic assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months) |
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| Secondary | Duration of Response (DOR) Per Central Radiographic Assessment | DOR is defined as the time from date of the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions. Results obtained via Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method. | Modified Intent-to-Treat Population (all patients who are randomized into this study and have measurable disease (per RECIST 1.1) at baseline) with a confirmed objective response (CR or PR) per central radiographic assessment. | Posted | Median | 95% Confidence Interval | Months | From randomization to the first documentation of disease progression (PD) or to death due to any cause in the absence of documented PD (Up to approximately 44 months) |
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| Secondary | Clinical Benefit Rate Per Central Radiographic Assessment | CBR is defined as the percentage of patients documented to have a confirmed CR, confirmed PR, or SD, according to RECIST 1.1 as the best response. Complete response (CR) is defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression. Progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. | The Modified Intent-to-Treat Population: all patients who are randomized into this study and have measurable disease (per RECIST 1.1) at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Per Central Radiographic Assessment | PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions. Censoring was assigned on the date of the last tumor assessment if no assessment of tumor progression is identified and the patient does not die while on study. Patients with no evaluation of disease after first study treatment will have PFS censored on the date of randomization. Patients who start new anti-cancer therapy prior to documented PD will be censored at the date of the last tumor assessment prior to the start of the new therapy. Results obtained using Kaplan-Meier estimation, Brookmeyer and Crowley (1982) method. | Intent-to-Treat population: all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 44 months) |
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| Secondary | 1-Year Survival Rate | 1-Year Survival will be defined as the percentage of participants surviving at 1 year after the first dose. Results obtained via Kaplan-Meier estimation, Greenwood's formula (1980). | Intent-to-Treat Population: All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months from first dose |
|
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| Secondary | Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score | The LCSS is a lung cancer specific measure of quality of life and includes 9 questions, including patient-reported ratings of six symptoms (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and three summary items (symptom distress, activity level, overall quality of life) using 100-mm visual analogue scales ranging from 0 (lowest rating) to 100 (highest rating). The average total score = is a sum of items 1 to 9 divided by the total number of items (sum of items 1 to 9) / 9). | Intent-to-Treat population (all randomized participants) with available scores for each assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49. |
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| Secondary | Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. | Intent-to-Treat population (all randomized participants) with available scores for each assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49. |
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| Secondary | Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) | The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points. | Intent-to-Treat population (all randomized participants) with available scores for each assessment. | Posted | Least Squares Mean | 95% Confidence Interval | Change in score on a scale | Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49. |
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| Secondary | Sitravatinib Plasma Concentration by Time Point | Pharmacokinetic Evaluable Population - all patients who received treatment with sitravatinib and had sufficient concentration-time data to permit calculation for sitravatinib at each time point | Posted | Mean | Standard Deviation | ng/mL | 0.5 hours post dose on cycle 1 (day 1) and 5 hours post dose on cycle 1 (day 1 and 15), and pre-dose on cycle 1 (day 15), and cycle 2, 3, and 5 (day 1) |
|
|
All-cause mortality was assessed from first dose to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose, and up to 100 days post last dose of nivolumab for immune-related AEs (Up to maximum of 38 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for SAE and Other (Not Including Serious) AE represents all participants that received at least 1 dose of study medication.
Adverse event analysis was pre-specified to be assessed per arm and not per dose/ capsule formulation since the nivolumab doses and sitravatinib capsule formulations were considered equivalent and interchangeable for the purposes of this study.
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 | Nivolumab and Sitravatinib | Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Nivolumab by intravenous infusion over 30 minutes at 240 milligram (mg) every 2 weeks or at 480 mg every 4 weeks at the discretion of the investigator . Sitravatinib malate capsules were administered at 100 mg orally, once daily (QD). | 200 | 284 | 126 | 281 | 277 | 281 |
| EG001 | Docetaxel | Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks. | 216 | 293 | 101 | 273 | 270 | 273 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Periumbilical abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Jejunal perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fluid overload | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronavirus test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial necrosis marker increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
Participants enrolled in the USA who began treatment with the sitravatinib free base capsule formulation prior to protocol amendment 03 will remain on the free base capsule formulation throughout the duration of the study; the starting dose of sitravatinib free base capsule formulation was 120 mg QD.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | 1-855-907-3286 | Clinical.Trials@bms.com |
| Mar 19, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000611865 | sitravatinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Not Reported |
|
| Unknown |
|
| Missing |
|
| OG001 |
| Docetaxel |
Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks. |
|
|
|
|
|
|
|
|
|
|
| OG001 | Docetaxel | Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks. |
|
|
Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks.
|
|
| OG001 | Docetaxel | Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks. |
|
|
|
|
|
Participants with Advanced Non-Squamous Non-Small Cell Lung Cancer were administered with Docetaxel by intravenous infusion at 75 milligram per meter square (mg/m^2) over 1 hour every 3 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|