A Phase 3 interventional study of Nivolumab and Sitravatinib in Metastatic Non-Squamous Non-Small Cell Lung Cancer, sponsored by Mirati Therapeutics Inc.. Terminated at 261 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Mirati Therapeutics Inc. (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
Inability to meet protocol objectives
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 577 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Mirati Therapeutics Inc. is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 4 (20%) have results posted.
First submitted before Mirati Therapeutics Inc. became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Nivolumab · Drug: Sitravatinib
Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Drug: Docetaxel
Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
Also known as: Opdivo
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Also known as: MGCD516
Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
Also known as: Taxotere
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.
Time frame: From randomization date to date of death due to any cause (Up to approximately 44 months)
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).
Time frame: 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 61 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.
Time frame: 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 61 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.
Time frame: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 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.
Time frame: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 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.
Time frame: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 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.
Time frame: 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 74 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.
Time frame: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 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.
Time frame: From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 74 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).
Time frame: 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) where a higher score represents a worse outcome. 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).
Time frame: 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.
Time frame: 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.
Time frame: Clinic visit closest to the disease evaluation on weeks 9, 17, 25, 33, 41, 49.
Sitravatinib Plasma Concentration by Time Point
Sitravatinib plasma concentration by time point. 1 cycle = 28 days.
Time frame: 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)
| Milestone | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Started | 284 | 293 |
| Safety population | 281 | 273 |
| Completed | 1 | 0 |
| Not completed | 283 | 293 |
| Withdrew: Death | 196 | 202 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Withdrawal by subject | 17 | 28 |
| Withdrew: Study terminated by sponsor | 29 | 23 |
| Withdrew: Other reasons | 38 | 36 |
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.
| Months | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Overall Survival (OS) | 12.22 (10.41 to 13.93) | 10.58 (9.40 to 12.29) |
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).
| Participants | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Any TEAE | 280 | 272 |
| Grade 3 or Greater TEAEs | 215 | 216 |
| Serious TEAEs | 128 | 102 |
| TEAEs Leading to Study Drug Dose Reduction or Interruption | 214 | 136 |
| Treatment-Related TEAEs Leading to Study Drug Dose Reduction or Interruption | 187 | 110 |
| Treatment-Related TEAEs Leading to Study Drug Discontinuation | 55 | 33 |
| TEAEs Leading to Study Discontinuation | 82 | 46 |
| Immune-Related TEAE | 129 | 0 |
| TEAE with Outcome of Death | 46 | 17 |
| Treatment-Related TEAEs with Outcome of Death | 1 | 3 |
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.
| Participants | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Discontinuation of Study Drug | 82 | 46 |
| Discontinuation of Nivolumab | 51 | — |
| Discontinuation of Sitravatinib | 79 | — |
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.
| Participants | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Hemoglobin (g/L) - Anemia — Grade 0 | 115 | 27 |
| Hemoglobin (g/L) - Anemia — Grade 1 | 136 | 146 |
| Hemoglobin (g/L) - Anemia — Grade 2 | 16 | 80 |
| Hemoglobin (g/L) - Anemia — Grade 3 | 7 | 16 |
| Hemoglobin (g/L) - Anemia — Grade 4 | 0 | 0 |
| Hemoglobin (g/L) - Anemia — Grade 5 | 0 | 0 |
| Hemoglobin (g/L) increased — Grade 0 | 235 | 268 |
| Hemoglobin (g/L) increased — Grade 1 | 35 | 1 |
| Hemoglobin (g/L) increased — Grade 2 | 3 | 0 |
| Hemoglobin (g/L) increased — Grade 3 | 1 | 0 |
| Hemoglobin (g/L) increased — Grade 4 | 0 | 0 |
| Hemoglobin (g/L) increased — Grade 5 | 0 | 0 |
| Neutrophils (10^9/L) count decreased — Grade 0 | 264 | 65 |
| Neutrophils (10^9/L) count decreased — Grade 1 | 8 | 8 |
| Neutrophils (10^9/L) count decreased — Grade 2 | 1 | 25 |
| Neutrophils (10^9/L) count decreased — Grade 3 | 1 | 42 |
| Neutrophils (10^9/L) count decreased — Grade 4 | 0 | 126 |
| Neutrophils (10^9/L) count decreased — Grade 5 | 0 | 0 |
| Platelets (10^9/L) count decreased — Grade 0 | 206 | 220 |
| Platelets (10^9/L) count decreased — Grade 1 | 64 | 44 |
| Platelets (10^9/L) count decreased — Grade 2 | 3 | 3 |
| Platelets (10^9/L) count decreased — Grade 3 | 0 | 1 |
| Platelets (10^9/L) count decreased — Grade 4 | 1 | 0 |
| Platelets (10^9/L) count decreased — Grade 5 | 0 | 0 |
| Lymphocytes (10^9/L) count decreased — Grade 0 | 116 | 59 |
| Lymphocytes (10^9/L) count decreased — Grade 1 | 59 | 39 |
| Lymphocytes (10^9/L) count decreased — Grade 2 | 66 | 82 |
| Lymphocytes (10^9/L) count decreased — Grade 3 | 33 | 73 |
| Lymphocytes (10^9/L) count decreased — Grade 4 | 0 | 11 |
| Lymphocytes (10^9/L) count decreased — Grade 5 | 0 | 0 |
| Lymphocytes (10^9/L) count increased — Grade 0 | 264 | 257 |
| Lymphocytes (10^9/L) count increased — Grade 1 | 0 | 0 |
| Lymphocytes (10^9/L) count increased — Grade 2 | 10 | 7 |
| Lymphocytes (10^9/L) count increased — Grade 3 | 0 | 0 |
| Lymphocytes (10^9/L) count increased — Grade 4 | 0 | 0 |
| Lymphocytes (10^9/L) count increased — Grade 5 | 0 | 0 |
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.
| Participants | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Alanine Aminotransferase (U/L) increased — Grade 0 | 105 | 228 |
| Alanine Aminotransferase (U/L) increased — Grade 1 | 151 | 37 |
| Alanine Aminotransferase (U/L) increased — Grade 2 | 10 | 0 |
| Alanine Aminotransferase (U/L) increased — Grade 3 | 8 | 1 |
| Alanine Aminotransferase (U/L) increased — Grade 4 | 0 | 0 |
| Alanine Aminotransferase (U/L) increased — Grade 5 | 0 | 0 |
| Aspartate Aminotransferase (U/L) increased — Grade 0 | 98 | 216 |
| Aspartate Aminotransferase (U/L) increased — Grade 1 | 165 | 49 |
| Aspartate Aminotransferase (U/L) increased — Grade 2 | 8 | 2 |
| Aspartate Aminotransferase (U/L) increased — Grade 3 | 3 | 0 |
| Aspartate Aminotransferase (U/L) increased — Grade 4 | 0 | 0 |
| Aspartate Aminotransferase (U/L) increased — Grade 5 | 0 | 0 |
| Creatinine (umol/L) increased — Grade 0 | 178 | 194 |
| Creatinine (umol/L) increased — Grade 1 | 65 | 55 |
| Creatinine (umol/L) increased — Grade 2 | 30 | 19 |
| Creatinine (umol/L) increased — Grade 3 | 0 | 0 |
| Creatinine (umol/L) increased — Grade 4 | 1 | 0 |
| Creatinine (umol/L) increased — Grade 5 | 0 | 0 |
| Bilirubin (umol/L) increased — Grade 0 | 252 | 240 |
| Bilirubin (umol/L) increased — Grade 1 | 17 | 20 |
| Bilirubin (umol/L) increased — Grade 2 | 4 | 6 |
| Bilirubin (umol/L) increased — Grade 3 | 1 | 1 |
| Bilirubin (umol/L) increased — Grade 4 | 0 | 0 |
| Bilirubin (umol/L) increased — Grade 5 | 0 | 0 |
| Sodium (mmol/L) - Hyponatremia — Grade 0 | 144 | 147 |
| Sodium (mmol/L) - Hyponatremia — Grade 1 | 106 | 100 |
| Sodium (mmol/L) - Hyponatremia — Grade 2 | 12 | 19 |
| Sodium (mmol/L) - Hyponatremia — Grade 3 | 9 | 2 |
| Sodium (mmol/L) - Hyponatremia — Grade 4 | 3 | 0 |
| Sodium (mmol/L) - Hyponatremia — Grade 5 | 0 | 0 |
| Sodium (mmol/L) - Hypernatremia — Grade 0 | 267 | 259 |
| Sodium (mmol/L) - Hypernatremia — Grade 1 | 6 | 9 |
| Sodium (mmol/L) - Hypernatremia — Grade 2 | 0 | 0 |
| Sodium (mmol/L) - Hypernatremia — Grade 3 | 1 | 0 |
| Sodium (mmol/L) - Hypernatremia — Grade 4 | 0 | 0 |
| Sodium (mmol/L) - Hypernatremia — Grade 5 | 0 | 0 |
| Potassium (mmol/L) - Hypokalemia — Grade 0 | 216 | 222 |
| Potassium (mmol/L) - Hypokalemia — Grade 1 | 42 | 37 |
| Potassium (mmol/L) - Hypokalemia — Grade 2 | 0 | 0 |
| Potassium (mmol/L) - Hypokalemia — Grade 3 | 15 | 9 |
| Potassium (mmol/L) - Hypokalemia — Grade 4 | 1 | 0 |
| Potassium (mmol/L) - Hypokalemia — Grade 5 | 0 | 0 |
| Potassium (mmol/L) - Hyperkalemia — Grade 0 | 216 | 213 |
| Potassium (mmol/L) - Hyperkalemia — Grade 1 | 35 | 40 |
| Potassium (mmol/L) - Hyperkalemia — Grade 2 | 18 | 12 |
| Potassium (mmol/L) - Hyperkalemia — Grade 3 | 2 | 3 |
| Potassium (mmol/L) - Hyperkalemia — Grade 4 | 3 | 0 |
| Potassium (mmol/L) - Hyperkalemia — Grade 5 | 0 | 0 |
| Urate (umol/L) - Hyperuricemia — Grade 0 | 186 | 224 |
| Urate (umol/L) - Hyperuricemia — Grade 1 | 87 | 42 |
| Urate (umol/L) - Hyperuricemia — Grade 2 | 0 | 0 |
| Urate (umol/L) - Hyperuricemia — Grade 3 | 0 | 0 |
| Urate (umol/L) - Hyperuricemia — Grade 4 | 0 | 0 |
| Urate (umol/L) - Hyperuricemia — Grade 5 | 0 | 0 |
| Lipase (U/L) increased — Grade 0 | 179 | 213 |
| Lipase (U/L) increased — Grade 1 | 41 | 24 |
| Lipase (U/L) increased — Grade 2 | 24 | 14 |
| Lipase (U/L) increased — Grade 3 | 20 | 9 |
| Lipase (U/L) increased — Grade 4 | 9 | 3 |
| Lipase (U/L) increased — Grade 5 | 0 | 0 |
| Amylase (U/L) increased — Grade 0 | 184 | 213 |
| Amylase (U/L) increased — Grade 1 | 44 | 26 |
| Amylase (U/L) increased — Grade 2 | 22 | 12 |
| Amylase (U/L) increased — Grade 3 | 13 | 3 |
| Amylase (U/L) increased — Grade 4 | 3 | 2 |
| Amylase (U/L) increased — Grade 5 | 0 | 0 |
| Alkaline Phosphatase (U/L) increased — Grade 0 | 160 | 201 |
| Alkaline Phosphatase (U/L) increased — Grade 1 | 107 | 62 |
| Alkaline Phosphatase (U/L) increased — Grade 2 | 2 | 2 |
| Alkaline Phosphatase (U/L) increased — Grade 3 | 5 | 1 |
| Alkaline Phosphatase (U/L) increased — Grade 4 | 0 | 0 |
| Alkaline Phosphatase (U/L) increased — Grade 5 | 0 | 0 |
| Albumin (g/L) - Hypoalbuminemia — Grade 0 | 106 | 109 |
| Albumin (g/L) - Hypoalbuminemia — Grade 1 | 81 | 83 |
| Albumin (g/L) - Hypoalbuminemia — Grade 2 | 81 | 72 |
| Albumin (g/L) - Hypoalbuminemia — Grade 3 | 6 | 3 |
| Albumin (g/L) - Hypoalbuminemia — Grade 4 | 0 | 0 |
| Albumin (g/L) - Hypoalbuminemia — Grade 5 | 0 | 0 |
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.
| Percentage of participants | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Objective Response Rate (ORR) Per Central Radiographic Assessment | 16.0 (11.88 to 20.76) | 17.2 (13.08 to 22.09) |
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.
| Months | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Duration of Response (DOR) Per Central Radiographic Assessment | 7.43 (5.36 to 13.08) | 7.10 (5.75 to 11.79) |
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.
| Percentage of participants | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Clinical Benefit Rate Per Central Radiographic Assessment | 75.5 (70.08 to 80.43) | 64.5 (58.68 to 69.99) |
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.
| Months | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Progression-Free Survival (PFS) Per Central Radiographic Assessment | 4.40 (3.91 to 5.42) | 5.42 (3.91 to 5.75) |
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).
| Percentage of participants | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| 1-Year Survival Rate | 50.68 (44.60 to 56.43) | 44.69 (38.68 to 50.52) |
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) where a higher score represents a worse outcome. 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).
| Score on a scale | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Assessment 1 (Week 9) | 2.972 ± 15.6202 | 2.394 ± 18.7744 |
| Assessment 2 (Week 17) | 1.591 ± 16.9547 | 6.357 ± 17.4287 |
| Assessment 3 (Week 25) | 2.564 ± 17.9842 | 6.565 ± 18.6062 |
| Assessment 4 (Week 33) | 3.368 ± 14.5191 | 4.284 ± 17.9242 |
| Assessment 5 (Week 41) | 5.080 ± 15.1775 | 4.285 ± 15.7422 |
| Assessment 6 (Week 49) | 2.843 ± 17.9960 | 12.192 ± 18.3685 |
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.
| Score on a scale | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Assessment 1 (Week 9) | -0.0865 ± 0.25109 | -0.0415 ± 0.23960 |
| Assessment 2 (Week 17) | -0.0629 ± 0.22582 | -0.1077 ± 0.21804 |
| Assessment 3 (Week 25) | -0.0748 ± 0.19868 | -0.1357 ± 0.21125 |
| Assessment 4 (Week 33) | -0.0640 ± 0.18523 | -0.0753 ± 0.23684 |
| Assessment 5 (Week 41) | -0.0545 ± 0.24921 | -0.0918 ± 0.21870 |
| Assessment 6 (Week 49) | -0.0298 ± 0.29730 | -0.1297 ± 0.17000 |
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.
| Change in score on a scale | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Assessment 1 (Week 9) | -4.4 ± 20.73 | -3.4 ± 20.07 |
| Assessment 2 (Week 17) | -2.9 ± 20.50 | -5.3 ± 22.34 |
| Assessment 3 (Week 25) | -1.9 ± 19.63 | -7.9 ± 20.89 |
| Assessment 4 (Week 33) | -1.5 ± 18.52 | -0.1 ± 19.10 |
| Assessment 5 (Week 41) | -2.1 ± 21.50 | -1.5 ± 13.36 |
| Assessment 6 (Week 49) | -2.5 ± 24.22 | -2.4 ± 19.38 |
Sitravatinib plasma concentration by time point. 1 cycle = 28 days.
| ng/mL | Nivolumab and Sitravatinib |
|---|---|
| Cycle 1 Day 1/ 30 mins Post-Dose | 2.73201 ± 4.816044 |
| Cycle 1 Day 1/ 5 hours Post-Dose | 32.41228 ± 21.358205 |
| Cycle 1 Day 15/ Pre-Dose | 75.72754 ± 35.261907 |
| Cycle 1 Day 15/ 5 hours Post-Dose | 89.71667 ± 36.289115 |
| Cycle 2 Day 1/ Pre-Dose | 62.20483 ± 27.055422 |
| Cycle 3 Day 1/ Pre-Dose | 51.90238 ± 19.946633 |
| Cycle 5 Day 1/ Pre-Dose | 50.40513 ± 24.995304 |
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.
| Months | Nivolumab and Sitravatinib | Docetaxel |
|---|---|---|
| Overall Survival (OS) - Extended Collection | 12.22 (10.41 to 14.19) | 10.58 (9.40 to 12.39) |
Collected over All-cause mortality was assessed from first dose to their study completion (up to approximately 74 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 61 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nivolumab + Sitravatinib | 202/284 (71.1%) | 128/281 (45.6%) | 275/281 (97.9%) |
| Docetaxel | 209/293 (71.3%) | 102/273 (37.4%) | 267/273 (97.8%) |
| Event | Nivolumab + Sitravatinib | Docetaxel |
|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 25/281 | 6/273 |
| PneumoniaInfections and infestations | 16/281 | 13/273 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/281 | 14/273 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 10/281 | 2/273 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/281 | 7/273 |
| ColitisGastrointestinal disorders | 7/281 | 1/273 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 6/281 | 1/273 |
| General physical health deteriorationGeneral disorders | 1/281 | 5/273 |
| COVID-19Infections and infestations | 2/281 | 5/273 |
| SepsisInfections and infestations | 3/281 | 5/273 |
| Event | Nivolumab + Sitravatinib | Docetaxel |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 180/281 | 107/273 |
| FatigueGeneral disorders | 100/281 | 112/273 |
| Decreased appetiteMetabolism and nutrition disorders | 108/281 | 82/273 |
| HypertensionVascular disorders | 105/281 | 14/273 |
| NauseaGastrointestinal disorders | 100/281 | 98/273 |
| Weight decreasedInvestigations | 93/281 | 32/273 |
| Neutrophil count decreasedInvestigations | 2/281 | 88/273 |
| AlopeciaSkin and subcutaneous tissue disorders | 9/281 | 85/273 |
| HypothyroidismEndocrine disorders | 85/281 | 6/273 |
| NeutropeniaBlood and lymphatic system disorders | 0/281 | 72/273 |
| Age, Continuous(years) | Nivolumab and Sitravatinib | Docetaxel | Total |
|---|---|---|---|
| Mean | 64.9 ± 8.48 | 65.0 ± 10.08 | 65.0 ± 9.32 |
| Sex: Female, Male(Participants) | Nivolumab and Sitravatinib | Docetaxel | Total |
|---|---|---|---|
| Female | 114 | 125 | 239 |
| Male | 170 | 168 | 338 |
| Ethnicity (NIH/OMB)(Participants) | Nivolumab and Sitravatinib | Docetaxel | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 18 | 30 |
| Not Hispanic or Latino | 219 | 207 | 426 |
| Unknown or Not Reported | 53 | 68 | 121 |
| Race/Ethnicity, Customized(participants) | Nivolumab and Sitravatinib | Docetaxel | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 7 | 9 | 16 |
| Black or African American | 8 | 14 | 22 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| White | 211 | 198 | 409 |
| Other | 4 | 3 | 7 |
| Not Reported | 34 | 46 | 80 |
| Unknown | 5 | 4 | 9 |
| Missing | 14 | 18 | 32 |
Showing the first 100 of 261 sites across 12 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2019 to primary completion in Mar 2023, 44 months.
Results were first posted in Jun 2024, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
Inability to meet protocol objectives
Inability to meet protocol objectives
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Studies of the drug tested here: Sitravatinib
Carcinoma, Non-Small-Cell Lung →