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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

SAPPHIRE Trial 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.Check my eligibility

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.See study design

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.

SAPPHIRE Trial 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.

Select...

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.

Select...

I am eligible for docetaxel as my second or third treatment option.

Select...

I have been diagnosed with non-squamous non-small cell lung cancer.

SAPPHIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Adverse Events (AEs)

Objective Response Rate (ORR)

Progression-Free Survival (PFS)

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%

Hypothyroidism

29%

Blood thyroid stimulating hormone increased

29%

Hypotension

29%

Myalgia

29%

Diarrhoea

29%

Urinary tract infection

29%

Vomiting

29%

Pain

29%

Amylase increased

14%

Arthralgia

14%

Cough

14%

Abdominal pain

14%

Acute respiratory failure

14%

Weight decreased

14%

Nasal congestion

14%

Epistaxis

14%

Flank pain

14%

Alanine aminotransferase increased

14%

Hyperuricaemia

14%

Memory impairment

14%

Musculoskeletal pain

14%

Night sweats

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%

Study treatment Arm

Sitravatinib 120 mg

Sitravatinib 80 mg

SAPPHIRE 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

~490

Nivolumab

2014

Completed Phase 3

~4750

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor

70 Previous Clinical Trials

7,531 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,650 Previous Clinical Trials

4,130,300 Total Patients Enrolled

Ronald L. Shazer, MD, MBAStudy DirectorMirati Therapeutics Inc.

~91 spots leftby Jun 2025

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