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Cytotoxic agent

Sitravatinib + Nivolumab for Advanced Non-Small Cell Lung Cancer (SAPPHIRE Trial)

Phase 3
Waitlist Available
Research Sponsored by Mirati Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
Must not have
Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization date to date of death due to any cause (up to approximately 44 months)
Awards & highlights

Summary

This trial will compare the effectiveness of sitravatinib when given with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression after platinum-based chemotherapy and checkpoint inhibitor therapy.

Who is the study for?
This trial is for adults with advanced non-squamous NSCLC who've had disease progression after platinum-based chemo and checkpoint inhibitor therapy. They should have tried one or two treatments before, but not more, and can't have uncontrolled brain metastases or certain genetic mutations.
What is being tested?
The study tests sitravatinib combined with nivolumab against docetaxel in patients whose lung cancer worsened despite previous therapies. It aims to see if the new combination is more effective than the standard treatment of docetaxel alone.
What are the potential side effects?
Sitravatinib may cause high blood pressure, fatigue, nausea, while Nivolumab can lead to immune-related issues like inflammation of organs. Docetaxel commonly causes hair loss, low white blood cell count increasing infection risk, and mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with both PD-1/PD-L1 inhibitors and platinum-based chemotherapy.
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My cancer progressed after treatment with a checkpoint inhibitor.
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I've had 1 or 2 treatments for my advanced illness.
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I've had treatments with PD-1/PD-L1 inhibitors and platinum-based chemotherapy.
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I am eligible for docetaxel as my second or third treatment option.
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I have been diagnosed with non-squamous non-small cell lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had cancer treatment after immunotherapy, not including maintenance chemo.
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My tumor is positive for EGFR, ROS1, ALK mutations, or ALK fusions.
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I have brain metastases that are not currently under control.
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I had severe side effects from previous immunotherapy.
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My heart doesn't work as well as it should.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization date to date of death due to any cause (up to approximately 44 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization date to date of death due to any cause (up to approximately 44 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
1-Year Survival Rate
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Health Utility Index (HUI)
Change From Baseline in the European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) - Visual Analogue Score (VAS)
+9 more

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT03680521
86%
Hypertension
71%
Dysphonia
57%
Headache
43%
Fatigue
43%
Constipation
43%
Lipase increased
43%
Oral dysaesthesia
29%
Blood thyroid stimulating hormone increased
29%
Pain
29%
Hypothyroidism
29%
Vomiting
29%
Diarrhoea
29%
Hypotension
29%
Myalgia
29%
Urinary tract infection
29%
Amylase increased
14%
Acute respiratory failure
14%
Flank pain
14%
Cough
14%
Alanine aminotransferase increased
14%
Epistaxis
14%
Night sweats
14%
Weight decreased
14%
Abdominal pain
14%
Arthralgia
14%
Hyperuricaemia
14%
Memory impairment
14%
Musculoskeletal pain
14%
Nasal congestion
14%
Urinary retention
14%
Nausea
14%
Rash
14%
Decreased appetite
14%
Dizziness
14%
Haematuria
14%
Nail discolouration
14%
Hypoglycaemia
14%
Oral herpes
14%
Pain in jaw
14%
Pneumonitis
14%
Procedural pain
14%
Pyrexia
14%
Rhinitis allergic
14%
Rhinorrhoea
14%
Sinus congestion
14%
Somnolence
14%
Thrombocytopenia
14%
Tinnitus
14%
Tooth abscess
14%
Herpes zoster
14%
Chills
14%
Urosepsis
14%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitravatinib 120 mg
Sitravatinib 80 mg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab and SitravatinibExperimental Treatment2 Interventions
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.
Group II: DocetaxelActive Control1 Intervention
Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
2017
Completed Phase 2
~510
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
7,552 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,068 Total Patients Enrolled
Ronald L. Shazer, MD, MBAStudy DirectorMirati Therapeutics Inc.
~94 spots leftby Sep 2025
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