Trial Outcomes & Findings for Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (NCT NCT03906071)

Last Updated: 2025-10-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

577 participants

Primary outcome timeframe

From randomization date to date of death due to any cause (Up to approximately 44 months)

Results posted on

2025-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	284	293
Overall Study Safety Population	281	273
Overall Study COMPLETED	84	77
Overall Study NOT COMPLETED	200	216

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	180	185
Overall Study Lost to Follow-up	3	3
Overall Study Withdrawal by Subject	15	27
Overall Study Other	2	1

Baseline Characteristics

Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab and Sitravatinib n=284 Participants 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.	Docetaxel n=293 Participants 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.	Total n=577 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 8.48 • n=5 Participants	65.0 years STANDARD_DEVIATION 10.08 • n=7 Participants	65.0 years STANDARD_DEVIATION 9.32 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	125 Participants n=7 Participants	239 Participants n=5 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	168 Participants n=7 Participants	338 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	219 Participants n=5 Participants	207 Participants n=7 Participants	426 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	53 Participants n=5 Participants	68 Participants n=7 Participants	121 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	211 Participants n=5 Participants	198 Participants n=7 Participants	409 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	34 Participants n=5 Participants	46 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Missing	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization date to date of death due to any cause (Up to approximately 44 months)

Population: Intent-to-Treat population: all randomized participants.

Outcome measures

Outcome measures
Measure	Docetaxel n=293 Participants 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.	Nivolumab and Sitravatinib n=284 Participants 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.
Overall Survival (OS)	10.58 Months Interval 9.4 to 12.29	12.22 Months Interval 10.41 to 13.93

SECONDARY outcome

Timeframe: 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)

Population: Safety Population: all patients who received any dose of study medication (i.e., sitravatinib, nivolumab or docetaxel)

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).

Outcome measures

Outcome measures
Measure	Docetaxel n=273 Participants 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.	Nivolumab and Sitravatinib n=281 Participants 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.
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Any TEAE	272 Participants	280 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Grade 3 or Greater TEAEs	216 Participants	214 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) TEAEs Leading to Study Drug Dose Reduction or Interruption	136 Participants	213 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Treatment-Related TEAEs Leading to Study Drug Dose Reduction or Interruption	110 Participants	184 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Treatment-Related TEAEs Leading to Study Drug Discontinuation	32 Participants	52 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) TEAEs Leading to Study Discontinuation	18 Participants	11 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Immune-Related TEAE	0 Participants	129 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) TEAE with Outcome of Death	17 Participants	46 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Treatment-Related TEAEs with Outcome of Death	3 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Serious TEAEs	101 Participants	126 Participants

SECONDARY outcome

Timeframe: 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)

Population: Safety Population: all patients who received any dose of study medication (i.e., sitravatinib, nivolumab or docetaxel)

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=273 Participants 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.	Nivolumab and Sitravatinib n=281 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation Discontinuation of Sitravatinib	—	74 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation Discontinuation of Study Drug	44 Participants	77 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation Discontinuation of Nivolumab	—	50 Participants

SECONDARY outcome

Timeframe: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months)

Population: Safety Population (all patients who received any dose of study medication) with at least 1 post-baseline result

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=269 Participants 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.	Nivolumab and Sitravatinib n=274 Participants 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.
Number of Participants With Maximum Post Baseline Hematology Grade Results Neutrophils (10^9/L) count decreased · Grade 2	25 Participants	1 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Platelets (10^9/L) count decreased · Grade 0	221 Participants	207 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Platelets (10^9/L) count decreased · Grade 1	43 Participants	63 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Platelets (10^9/L) count decreased · Grade 2	3 Participants	3 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Platelets (10^9/L) count decreased · Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Platelets (10^9/L) count decreased · Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Neutrophils (10^9/L) count decreased · Grade 3	42 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Neutrophils (10^9/L) count decreased · Grade 4	126 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Neutrophils (10^9/L) count decreased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) - Anemia · Grade 0	27 Participants	118 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) - Anemia · Grade 1	146 Participants	134 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) - Anemia · Grade 2	80 Participants	16 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) - Anemia · Grade 3	16 Participants	6 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) - Anemia · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) - Anemia · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) increased · Grade 0	268 Participants	236 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) increased · Grade 1	1 Participants	35 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) increased · Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) increased · Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) increased · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Hemoglobin (g/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Neutrophils (10^9/L) count decreased · Grade 0	66 Participants	265 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Neutrophils (10^9/L) count decreased · Grade 1	7 Participants	8 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Platelets (10^9/L) count decreased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count decreased · Grade 0	59 Participants	117 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count decreased · Grade 1	39 Participants	58 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count decreased · Grade 2	83 Participants	66 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count decreased · Grade 3	72 Participants	33 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count decreased · Grade 4	11 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count decreased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count increased · Grade 0	257 Participants	266 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count increased · Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count increased · Grade 2	7 Participants	8 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count increased · Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count increased · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Hematology Grade Results Lymphocytes (10^9/L) count increased · Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 36 months)

Population: Safety Population (all patients who received any dose of study medication) with at least 1 post-baseline result

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=268 Participants 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.	Nivolumab and Sitravatinib n=274 Participants 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.
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hypokalemia · Grade 0	222 Participants	217 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Lipase (U/L) increased · Grade 0	213 Participants	181 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alkaline Phosphatase (U/L) increased · Grade 2	2 Participants	2 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alkaline Phosphatase (U/L) increased · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alanine Aminotransferase (U/L) increased · Grade 0	228 Participants	106 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alanine Aminotransferase (U/L) increased · Grade 1	37 Participants	151 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alanine Aminotransferase (U/L) increased · Grade 2	0 Participants	10 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alanine Aminotransferase (U/L) increased · Grade 3	1 Participants	7 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alanine Aminotransferase (U/L) increased · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alanine Aminotransferase (U/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Aspartate Aminotransferase (U/L) increased · Grade 0	216 Participants	100 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Aspartate Aminotransferase (U/L) increased · Grade 1	49 Participants	163 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Aspartate Aminotransferase (U/L) increased · Grade 2	2 Participants	8 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Aspartate Aminotransferase (U/L) increased · Grade 3	0 Participants	3 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Aspartate Aminotransferase (U/L) increased · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Aspartate Aminotransferase (U/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Creatinine (umol/L) increased · Grade 0	194 Participants	180 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Creatinine (umol/L) increased · Grade 1	55 Participants	67 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Creatinine (umol/L) increased · Grade 2	19 Participants	27 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Creatinine (umol/L) increased · Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Creatinine (umol/L) increased · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Creatinine (umol/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Bilirubin (umol/L) increased · Grade 0	240 Participants	252 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Bilirubin (umol/L) increased · Grade 1	20 Participants	17 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Bilirubin (umol/L) increased · Grade 2	6 Participants	4 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Bilirubin (umol/L) increased · Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Bilirubin (umol/L) increased · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Bilirubin (umol/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hyponatremia · Grade 0	147 Participants	147 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hyponatremia · Grade 1	100 Participants	105 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hyponatremia · Grade 2	19 Participants	11 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hyponatremia · Grade 3	2 Participants	9 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hyponatremia · Grade 4	0 Participants	2 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hyponatremia · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hypernatremia · Grade 0	259 Participants	268 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hypernatremia · Grade 1	9 Participants	5 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hypernatremia · Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hypernatremia · Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hypernatremia · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Sodium (mmol/L) - Hypernatremia · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hypokalemia · Grade 1	37 Participants	41 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hypokalemia · Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hypokalemia · Grade 3	9 Participants	15 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hypokalemia · Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hypokalemia · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hyperkalemia · Grade 0	213 Participants	217 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hyperkalemia · Grade 1	40 Participants	34 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hyperkalemia · Grade 2	12 Participants	20 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hyperkalemia · Grade 3	3 Participants	2 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hyperkalemia · Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Potassium (mmol/L) - Hyperkalemia · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Urate (umol/L) - Hyperuricemia · Grade 0	224 Participants	189 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Urate (umol/L) - Hyperuricemia · Grade 1	42 Participants	84 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Urate (umol/L) - Hyperuricemia · Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Urate (umol/L) - Hyperuricemia · Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Urate (umol/L) - Hyperuricemia · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Urate (umol/L) - Hyperuricemia · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Lipase (U/L) increased · Grade 1	24 Participants	41 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Lipase (U/L) increased · Grade 2	14 Participants	22 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Lipase (U/L) increased · Grade 3	9 Participants	20 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Lipase (U/L) increased · Grade 4	3 Participants	9 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Lipase (U/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Amylase (U/L) increased · Grade 0	213 Participants	184 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Amylase (U/L) increased · Grade 1	26 Participants	46 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Amylase (U/L) increased · Grade 2	12 Participants	20 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Amylase (U/L) increased · Grade 3	3 Participants	13 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Amylase (U/L) increased · Grade 4	2 Participants	3 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Amylase (U/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alkaline Phosphatase (U/L) increased · Grade 0	201 Participants	162 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alkaline Phosphatase (U/L) increased · Grade 1	62 Participants	105 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alkaline Phosphatase (U/L) increased · Grade 3	1 Participants	5 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Alkaline Phosphatase (U/L) increased · Grade 5	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Albumin (g/L) - Hypoalbuminemia · Grade 0	109 Participants	108 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Albumin (g/L) - Hypoalbuminemia · Grade 1	83 Participants	81 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Albumin (g/L) - Hypoalbuminemia · Grade 2	72 Participants	79 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Albumin (g/L) - Hypoalbuminemia · Grade 3	3 Participants	6 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Albumin (g/L) - Hypoalbuminemia · Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post Baseline Chemistry Grade Results Albumin (g/L) - Hypoalbuminemia · Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=290 Participants 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.	Nivolumab and Sitravatinib n=282 Participants 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.
Objective Response Rate (ORR) Per Central Radiographic Assessment	17.2 Percentage of participants Interval 13.08 to 22.09	15.6 Percentage of participants Interval 11.57 to 20.37

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=50 Participants 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.	Nivolumab and Sitravatinib n=44 Participants 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.
Duration of Response (DOR) Per Central Radiographic Assessment	7.10 Months Interval 5.85 to 11.79	7.43 Months Interval 5.36 to 13.08

SECONDARY outcome

Timeframe: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 44 months)

Population: The Modified Intent-to-Treat Population: all patients who are randomized into this study and have measurable disease (per RECIST 1.1) at baseline.

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=290 Participants 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.	Nivolumab and Sitravatinib n=282 Participants 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.
Clinical Benefit Rate Per Central Radiographic Assessment	64.5 Percentage of participants Interval 58.68 to 69.99	75.5 Percentage of participants Interval 70.08 to 80.43

SECONDARY outcome

Timeframe: From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 44 months)

Population: Intent-to-Treat population: all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=293 Participants 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.	Nivolumab and Sitravatinib n=284 Participants 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.
Progression-Free Survival (PFS) Per Central Radiographic Assessment	5.42 Months Interval 3.91 to 5.75	4.40 Months Interval 3.91 to 5.42

SECONDARY outcome

Timeframe: At 12 months from first dose

Population: Intent-to-Treat Population: All randomized participants

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).

Outcome measures

Outcome measures
Measure	Docetaxel n=293 Participants 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.	Nivolumab and Sitravatinib n=284 Participants 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.
1-Year Survival Rate	44.12 Percentage of participants Interval 38.01 to 50.05	50.18 Percentage of participants Interval 44.05 to 55.99

SECONDARY outcome

Timeframe: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.

Population: Intent-to-Treat population (all randomized participants) with available scores for each assessment.

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).

Outcome measures

Outcome measures
Measure	Docetaxel n=142 Participants 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.	Nivolumab and Sitravatinib n=177 Participants 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.
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score Assessment 1 (Week 9)	2.75 Score on a scale Interval 0.27 to 5.24	4.10 Score on a scale Interval 1.87 to 6.33
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score Assessment 2 (Week 17)	5.78 Score on a scale Interval 2.8 to 8.75	2.74 Score on a scale Interval 0.24 to 5.25
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score Assessment 3 (Week 25)	7.92 Score on a scale Interval 4.58 to 11.27	4.58 Score on a scale Interval 1.8 to 7.35
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score Assessment 4 (Week 33)	5.83 Score on a scale Interval 1.77 to 9.89	4.08 Score on a scale Interval 0.92 to 7.23
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score Assessment 5 (Week 41)	5.12 Score on a scale Interval 0.5 to 9.74	6.73 Score on a scale Interval 3.09 to 10.37
Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Average Total Score Assessment 6 (Week 49)	10.85 Score on a scale Interval 5.49 to 16.21	3.91 Score on a scale Interval -0.35 to 8.16

SECONDARY outcome

Timeframe: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.

Population: Intent-to-Treat population (all randomized participants) with available scores for each assessment.

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=154 Participants 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.	Nivolumab and Sitravatinib n=193 Participants 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.
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) Assessment 5 (Week 41)	-0.12 Score on a scale Interval -0.18 to -0.05	-0.08 Score on a scale Interval -0.14 to -0.03
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) Assessment 1 (Week 9)	-0.05 Score on a scale Interval -0.08 to -0.01	-0.09 Score on a scale Interval -0.12 to -0.06
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) Assessment 2 (Week 17)	-0.10 Score on a scale Interval -0.14 to -0.06	-0.07 Score on a scale Interval -0.11 to -0.04
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) Assessment 3 (Week 25)	-0.15 Score on a scale Interval -0.2 to -0.1	-0.10 Score on a scale Interval -0.14 to -0.06
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) Assessment 4 (Week 33)	-0.09 Score on a scale Interval -0.15 to -0.03	-0.09 Score on a scale Interval -0.13 to -0.04
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI) Assessment 6 (Week 49)	-0.15 Score on a scale Interval -0.23 to -0.07	-0.10 Score on a scale Interval -0.16 to -0.04

SECONDARY outcome

Timeframe: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.

Population: Intent-to-Treat population (all randomized participants) with available scores for each assessment.

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.

Outcome measures

Outcome measures
Measure	Docetaxel n=154 Participants 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.	Nivolumab and Sitravatinib n=193 Participants 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.
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) Assessment 6 (Week 49)	-4.17 Change in score on a scale Interval -10.48 to 2.15	-6.05 Change in score on a scale Interval -10.8 to -1.31
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) Assessment 1 (Week 9)	-3.77 Change in score on a scale Interval -6.52 to -1.01	-4.74 Change in score on a scale Interval -7.21 to -2.27
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) Assessment 2 (Week 17)	-5.12 Change in score on a scale Interval -8.37 to -1.86	-3.24 Change in score on a scale Interval -6.03 to -0.45
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) Assessment 3 (Week 25)	-8.72 Change in score on a scale Interval -12.46 to -4.98	-3.37 Change in score on a scale Interval -6.49 to -0.25
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) Assessment 4 (Week 33)	-2.71 Change in score on a scale Interval -7.3 to 1.88	-3.41 Change in score on a scale Interval -7.0 to 0.19
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS) Assessment 5 (Week 41)	-2.89 Change in score on a scale Interval -8.17 to 2.38	-3.55 Change in score on a scale Interval -7.71 to 0.61

SECONDARY outcome

Timeframe: 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)

Population: 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

Outcome measures

Outcome measures
Measure	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.	Nivolumab and Sitravatinib n=227 Participants 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.
Sitravatinib Plasma Concentration by Time Point Cycle 1 Day 1/ 30 mins Post-Dose	—	2.73201 ng/mL Standard Deviation 4.816044
Sitravatinib Plasma Concentration by Time Point Cycle 1 Day 1/ 5 hours Post-Dose	—	32.41228 ng/mL Standard Deviation 21.358205
Sitravatinib Plasma Concentration by Time Point Cycle 1 Day 15/ Pre-Dose	—	75.72754 ng/mL Standard Deviation 35.261907
Sitravatinib Plasma Concentration by Time Point Cycle 1 Day 15/ 5 hours Post-Dose	—	89.71667 ng/mL Standard Deviation 36.289115
Sitravatinib Plasma Concentration by Time Point Cycle 2 Day 1/ Pre-Dose	—	62.20483 ng/mL Standard Deviation 27.055422
Sitravatinib Plasma Concentration by Time Point Cycle 3 Day 1/ Pre-Dose	—	51.90238 ng/mL Standard Deviation 19.946633
Sitravatinib Plasma Concentration by Time Point Cycle 5 Day 1/ Pre-Dose	—	50.40513 ng/mL Standard Deviation 24.995304

Adverse Events

Nivolumab and Sitravatinib

Serious events: 126 serious events

Other events: 277 other events

Deaths: 200 deaths

Docetaxel

Serious events: 101 serious events

Other events: 270 other events

Deaths: 216 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: 1-855-907-3286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER