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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
Select...
I have been treated with both PD-1/PD-L1 inhibitors and platinum-based chemotherapy.
Select...
My cancer progressed after treatment with a checkpoint inhibitor.
Select...
I've had 1 or 2 treatments for my advanced illness.
Select...
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 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%
Blood thyroid stimulating hormone increased
29%
Hypotension
29%
Hypothyroidism
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%
0%
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
2021
Completed Phase 2
~700
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
7,723 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,127,982 Total Patients Enrolled
Ronald L. Shazer, MD, MBAStudy DirectorMirati Therapeutics Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other Sitravatinib clinical trials that have been completed?

"Sitravatinib is currently being trialed in 1072 studies, 207 of which are Phase 3 trials. The primary location for these Sitravatinib trials is Fuzhou, Fujian; however, there are a total of 61220 locations running similar studies."

Answered by AI

Are there currently any open slots for new patients in this study?

"The trial, which was last updated on May 4th, 2022 is not currently recruiting patients according to the information found on clinicaltrials.gov. Although this study isn't presently looking for participants, there are 3023 other trials that are."

Answered by AI

What is Sitravatinib used to treat?

"Sitravatinib is most commonly used for treatment of malignant neoplasms. It can also be prescribed to treat other conditions like unresectable melanoma, squamous cell carcinoma, and sarcoma."

Answered by AI

In how many different places is this research project taking place?

"This clinical trial is accepting patients at Saint Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center in Fullerton, California; Yuma Regional Medical Center in Yuma, Arizona; Memorial Regional Hospital in Hollywood, Florida; and 100 other locations."

Answered by AI

How many individuals are able to participate in this clinical research?

"This study is not presently looking for new participants. The original posting date was July 15th, 2019 and the last update occurred on May 4th, 2022. However, there are 1951 other trials related to carcinoma, non-small-cell lung and 1072 trials involving Sitravatinib that are actively recruiting patients."

Answered by AI

Who else is applying?

What site did they apply to?
Palo Verde Cancer Specialists - Glendale
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
2019. "Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03906071.
All > Hawaii > Paid Studies Maine
~93 spots leftby Apr 2025
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