AzTrials
AzTrials

Metastatic Non-Squamous Non-Small Cell Lung CancerPhase 3SAPPHIRENCT03906071

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

A Phase 3 study testing Nivolumab, Sitravatinib and Docetaxel in people with Metastatic Non-Squamous Non-Small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 261 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Sitravatinib and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
577 participants
Where
261 sitesin 12 countries
Study dates
15 Jul 2019to 30 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
  • Receipt of at least one but not more than two prior treatment regimens in the advanced setting
  • 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
  • Candidate to receive docetaxel as second or third line therapy

Who cannot join

  • Uncontrolled brain metastases
  • Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
  • Unacceptable toxicity with prior checkpoint inhibitor therapy
  • Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
  • Impaired heart function

Trial locations and contacts

261 sites in 12 countries.

261 sites in 12 countries

United States133 sites

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • University Cancer & Blood Center (UCBC) - Athens

    Athens, Georgia, 30607

  • Local Institution - 005-146

    Atlanta, Georgia, 30318

  • Local Institution - 005-134

    Austin, Texas, 78745

  • Comprehensive Blood and Cancer Center - Bakersfield

    Bakersfield, California, 93309

  • Local Institution - 005-075

    Beaumont, Texas, 77702

  • Overlake Medical Center and Clinics

    Bellevue, Washington, 98004

  • Local Institution - 005-118

    Beverly Hills, California, 90211

  • Sisters of Charity of Leavenworth Health St. Marys

    Billings, Montana, 59102

  • Local Institution - 005-164

    Birmingham, Alabama, 35243

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Local Institution - 005-196

    Canton, Ohio, 44708

  • Local Institution - 005-144

    Charlottesville, Virginia, 22903

  • Local Institution - 005-151

    Chicago, Illinois, 60625-3645

  • USOR - Oncology Hematology Care - Blue Ash

    Cincinnati, Ohio, 45242

  • Local Institution - 005-191

    Coeur d'Alene, Idaho, 83814

  • John B. Amos Cancer Center Research

    Columbus, Georgia, 31904

  • Local Institution - 005-181

    Columbus, Ohio, 43210

  • Local Institution - 005-128

    Dallas, Texas, 75203

  • Local Institution - 005-129

    Dallas, Texas, 75231

  • Local Institution - 005-126

    Dallas, Texas, 75246

  • Commonwealth Cancer Center - Frankfort

    Danville, Kentucky, 40422

  • USOR - Texas Oncology Northeast Texas - Denison

    Denison, Texas, 75020

  • Local Institution - 005-124

    Denton, Texas, 76201

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Local Institution - 005-137A

    Dickson, Tennessee, 37055

  • Local Institution - 005-137B

    Dickson, Tennessee, 37055

  • Local Institution - 005-137C

    Dickson, Tennessee, 37055

  • Local Institution - 005-137D

    Dickson, Tennessee, 37055

  • Local Institution - 005-137E

    Dickson, Tennessee, 37055

  • Local Institution - 005-137F

    Dickson, Tennessee, 37055

  • Local Institution - 005-137G

    Dickson, Tennessee, 37055

  • Local Institution - 005-137H

    Dickson, Tennessee, 37055

  • Local Institution - 005-137I

    Dickson, Tennessee, 37055

  • Local Institution - 005-137J

    Dickson, Tennessee, 37055

  • Local Institution - 005-137K

    Dickson, Tennessee, 37055

  • Local Institution - 005-137L

    Dickson, Tennessee, 37055

  • Local Institution - 005-110

    Evanston, Illinois, 60201

  • Local Institution - 005-082

    Everett, Washington, 98201

  • Local Institution - 005-142

    Florham Park, New Jersey, 07932

  • Michael and Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308

  • Local Institution - 005-120

    Fort Myers, Florida, 33901

  • Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office

    Fort Wayne, Indiana, 46804

  • The Center for Cancer & Blood Disorders - Fort Worth

    Fort Worth, Texas, 76104

  • Hematology Oncology Associates of Fredericksburg

    Fredericksburg, Virginia, 24408

  • Local Institution - 005-171

    Fresno, California, 93720

  • Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton

    Fullerton, California, 92835

  • Palo Verde Cancer Specialists - Glendale

    Glendale, Arizona, 85304

  • Local Institution - 005-122

    Goshen, Indiana, 46526

  • Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • The Oncology Institute of Hope & Innovation - Henderson

    Henderson, Nevada, 89052

  • Local Institution - 005-152

    Henderson, Nevada, 89074

  • Local Institution - 005-137M

    Hendersonville, Tennessee, 37075

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Straub Medical Center

    Honolulu, Hawaii, 96813

  • USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates)

    Horsham, Pennsylvania, 19044

  • Oncology Consultants - Texas Medical Center

    Houston, Texas, 77030

  • Local Institution - 005-076

    Houston, Texas, 77070

  • Millennium Research and Clinical Development

    Houston, Texas, 77090

  • Clearview Cancer Institute - Huntsville

    Huntsville, Alabama, 35805

  • Franciscan Health Cancer Center Indianapolis

    Indianapolis, Indiana, 46237

  • USOR - US Oncology Investigational Products Center

    Irving, Texas, 75063

  • Jackson Oncology Associates - The Hederman Cancer Center

    Jackson, Mississippi, 39202

  • Local Institution - 005-123

    Johnson City, New York, 13790

  • Local Institution - 005-174

    Jonesboro, Arkansas, 72401

  • NEA Baptist Fowler Family Center for Cancer Care

    Jonesboro, Arkansas, 72401

  • Kansas City Care Health Center - Research Medical Campus

    Kansas City, Missouri, 64132

  • Local Institution - 005-097

    Lafayette, Colorado, 80026

  • Local Institution - 005-150

    Lafayette, Indiana, 47904

  • Local Institution - 005-182

    Lake Success, New York, 11042

  • Watson Clinic Cancer and Research Center

    Lakeland, Florida, 33805

  • Local Institution - 005-163

    Little Silver, New Jersey, 07739

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Local Institution - 005-096

    Long Beach, California, 90813

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Local Institution - 005-185

    Los Angeles, California, 90095

  • Local Institution - 005-153

    Louisville, Kentucky, 40241

  • Local Institution - 005-116

    Madison, Wisconsin, 53792

  • Local Institution - 005-119

    Marietta, Georgia, 30060

  • Tricounty Hematology and Oncology - Massillon

    Massillon, Ohio, 44646

  • Local Institution - 005-125

    McKinney, Texas, 75071

  • Local Institution - 005-195

    Memphis, Tennessee, 38120

  • Mount Sinai Health System

    Miami Beach, Florida, 33140

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Local Institution - 005-127

    Minneapolis, Minnesota, 55404

  • Local Institution - 005-120E

    Naples, Florida, 34102

  • Local Institution - 005-137

    Nashville, Tennessee, 37203

  • Local Institution - 005-072

    Newport Beach, California, 92663

  • Local Institution - 005-198

    Niles, Illinois, 60714

  • Local Institution - 005-109

    Northridge, California, 91325

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Local Institution - 005-079

    Ocala, Florida, 34474

  • Local Institution - 005-088

    Oklahoma City, Oklahoma, 73120

  • Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • Local Institution - 005-104

    Orlando, Florida, 32804

  • Local Institution - 005-186

    Philadelphia, Pennsylvania, 19111

  • New York Cancer & Blood Specialists - Port Jefferson Medical Oncology

    Port Jefferson Station, New York, 11776

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Local Institution - 005-073

    Portland, Oregon, 97239

  • Local Institution - 005-177

    Redlands, California, 92373

  • Virginia Cancer Institute - West End

    Richmond, Virginia, 23229

  • Local Institution - 005-112

    Riverside, California, 92501

  • Local Institution - 005-178

    Rockville, Maryland, 20850-6535

  • Local Institution - 005-159

    Saint Louis Park, Minnesota, 55426-5000

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • University of California San Francisco

    San Francisco, California, 94143

  • Local Institution - 005-176

    San Marcos, California, 92069

  • New England Cancer Specialists - Scarborough

    Scarborough, Maine, 04074

  • Local Institution - 005-111

    Seattle, Washington, 98109--1023

  • Orchard Healthcare Research

    Skokie, Illinois, 60077

  • Regional Cancer Care Associates - Sparta

    Sparta, New Jersey, 07871

  • Local Institution - 005-187

    Spokane, Washington, 99218

  • Highlands Oncology Group - Springdale

    Springdale, Arkansas, 72762

  • SCRI - Florida Cancer Specialists - North Region Research Office

    St. Petersburg, Florida, 33705

  • Local Institution - 005-107

    Stony Brook, New York, 11794

  • USOR - Texas Oncology - Sugar Land

    Sugar Land, Texas, 77479

  • Local Institution - 005-081

    Tacoma, Washington, 98405

  • Northwest Medical Specialties - Tacoma

    Tacoma, Washington, 98405

  • SCRI - Florida Cancer Specialists - Panhandle Research Office

    Tallahassee, Florida, 32308

  • Healthcare Research Network - Tinley Park

    Tinley Park, Illinois, 60487

  • Local Institution - 005-103

    Toledo, Ohio, 43623

  • Local Institution - 005-192

    Torrance, California, 90505

  • The Oncology Institute of Hope & Innovation - Tucson

    Tucson, Arizona, 85745

  • USOR - Texas Oncology Northeast Texas - Cancer and Research Institute - Tyler

    Tyler, Texas, 75702

  • Local Institution - 005-136

    Vancouver, Washington, 98684

  • Local Institution - 005-090

    West Covina, California, 91790

  • Local Institution - 005-154

    West Palm Beach, Florida, 33401

  • Local Institution - 005-169

    Westwood, Kansas, 66205

  • Local Institution - 005-105

    Whittier, California, 90602

  • Local Institution - 005-098

    Wichita, Kansas, 67214

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Spain24 sites

  • Local Institution - 005-807

    A Coruña, 15006

  • Local Institution - 005-800

    Badalona, 08916

  • Local Institution - 005-822

    Barcelona, 08003

  • Local Institution - 005-811

    Barcelona, 08028

  • Local Institution - 005-810

    Barcelona, 08035

  • Local Institution - 005-805

    Jaén, 23007

  • Local Institution - 005-816

    Las Palmas de Gran Canaria, 35016

  • Local Institution - 005-817

    León, 24071

  • Local Institution - 005-812

    Lugo, 27003

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Local Institution - 005-808

    Madrid, 28006

  • Local Institution - 005-819

    Madrid, 28027

  • Local Institution - 005-821

    Madrid, 28034

  • Local Institution - 005-813

    Madrid, 28040

  • Local Institution - 005-815

    Madrid, 28040

  • Local Institution - 005-809

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Local Institution - 005-806

    Majadahonda, 28222

  • Local Institution - 005-801

    Málaga, 29009

  • Local Institution - 005-803

    Oviedo, 33011

  • Local Institution - 005-823

    Santiago de Compostela, 15706

  • IVO - Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

  • Local Institution - 005-804

    Valencia, 46026

  • Local Institution - 005-818

    Vigo, 36312

Other trials in Spain

France16 sites

  • Local Institution - 005-307

    Brest, 29200

  • Local Institution - 005-310

    Bron, 69500

  • Local Institution - 005-311

    Créteil, 94000

  • Local Institution - 005-303

    Dijon, 21079

  • Local Institution - 005-309

    Le Mans, 72037

  • Local Institution - 005-308

    Limoges, 87042

  • Local Institution - 005-317

    Lyon, 69008

  • Local Institution - 005-301

    Marseille, 13009

  • Local Institution - 005-312

    Marseille, 13015

  • Local Institution - 005-313

    Montpellier, 34298

  • Local Institution - 005-306

    Mulhouse, 68100

  • Local Institution - 005-302

    Paris, 75018

  • Local Institution - 005-314

    Rouen, 76031

  • Local Institution - 005-316

    Saint-Herblain, 44805

  • Local Institution - 005-305

    Strasbourg, 67200

  • Local Institution - 005-304

    Villejuif, 94805

Other trials in France

Germany16 sites

  • Local Institution - 005-400

    Bad Berka, 99437

  • Local Institution - 005-418

    Berlin, 13125

  • Local Institution - 005-401

    Bonn, 53127

  • Local Institution - 005-412

    Cologne, 51109

  • Local Institution - 005-419

    Essen, 45136

  • Local Institution - 005-406

    Esslingen am Neckar, 73730

  • Local Institution - 005-403

    Gauting, 82131

  • Local Institution - 005-417

    Grohansdorf, 22927

  • Local Institution - 005-408

    Halle, 06120

  • Local Institution - 005-411

    Immenstadt im Allgäu, 87509

  • Local Institution - 005-416

    Kassel, 34125

  • Local Institution - 005-410

    Löwenstein, 74245

  • Local Institution - 005-405

    Lübeck, 23538

  • Local Institution - 005-414

    Mainz, 55131

  • Local Institution - 005-413

    München, 81675

  • Local Institution - 005-402

    München, 81925

Other trials in Germany

Italy14 sites

  • Local Institution - 005-612

    Alessandria, 15121

  • Local Institution - 005-602

    Bari, 70124

  • Local Institution - 005-603

    Catania, 95123

  • Local Institution - 005-611

    Cremona, 26100

  • Local Institution - 005-608

    Lecce, 73100

  • Local Institution - 005-610

    Meldola, 47014

  • Local Institution - 005-606

    Milan, 20141

  • Local Institution - 005-605

    Monza, 20900

  • Local Institution - 005-604

    Naples, 80131

  • Local Institution - 005-600

    Parma, 43126

  • Local Institution - 005-607

    Piacenza, 29100

  • Local Institution - 005-609

    Pisa, 56126

  • Local Institution - 005-614

    Roma, 00144

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Netherlands14 sites

  • Local Institution - 005-700

    's-Hertogenbosch, 5223 GZ

  • Local Institution - 005-703

    Amsterdam, 1066 CX

  • Local Institution - 005-711

    Amsterdam, 1081 HV

  • Local Institution - 005-707

    Breda, 4818 CK

  • Local Institution - 005-713

    Dordrecht, 3318 AT

  • Local Institution - 005-702

    Groningen, 9728 NT

  • Local Institution - 005-712

    Maastricht, 6229 HX

  • Local Institution - 005-714

    Nijmegen, 6525 GA

  • Local Institution - 005-710

    Rotterdam, 3015 GD

  • Local Institution - 005-705

    Rotterdam, 3045 PM

  • Local Institution - 005-709

    The Hague, 2545 AA

  • Local Institution - 005-701

    Utrecht, 3543 AZ

  • Local Institution - 005-708

    Utrecht, 3584 CX

  • Local Institution - 005-706

    Zwolle, 8025 AB

Other trials in Netherlands

Canada9 sites

  • Local Institution - 005-259

    Calgary, Alberta, T2N 4N2

  • Local Institution - 005-252

    Hamilton, Ontario, L8V 5C2

  • Local Institution - 005-250

    Moncton, New Brunswick, E1C 6Z8

  • Local Institution - 005-255

    Montreal, Quebec, H3A 0G4

  • Local Institution - 005-258

    Québec, G1V 4G5

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Local Institution - 005-251

    Toronto, Ontario, M5G 2M9

  • Local Institution - 005-257

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Belgium8 sites

  • Local Institution - 005-201

    Brasschaat, 2930

  • Local Institution - 005-200

    Charleroi, 6000

  • Local Institution - 005-206

    Edegem, 2650

  • Local Institution - 005-202

    Ghent, 9000

  • Local Institution - 005-207

    Ghent, 9000

  • Local Institution - 005-205

    Roeselare, 8800

  • Local Institution - 005-204

    Ronse, 9600

  • Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

    Yvoir, B-5530

Other trials in Belgium

Hungary8 sites

  • Local Institution - 005-454

    Budapest, 1083

  • Local Institution - 005-457

    Budapest, 1121

  • Local Institution - 005-455

    Budapest, 1122

  • Local Institution - 005-453

    Farkasgyepű, 8582

  • Local Institution - 005-452

    Győr, 9023

  • Local Institution - 005-451

    Szombathely, 9700

  • Local Institution - 005-450

    Tatabánya, 2800

  • Local Institution - 005-456

    Törökbálint, 2045

Other trials in Hungary

United Kingdom8 sites

  • Velindre University NHS Trust

    Cardiff, CF14 2TL

  • Local Institution - 005-904

    Cornwall, TR1 3LJ

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW

  • Local Institution - 005-908

    London, NW3 2QG

  • Local Institution - 005-900

    London, SW3 6JJ

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Local Institution - 005-903

    Middlesex, HA6 2RN

Other trials in United Kingdom

Israel7 sites

  • Local Institution - 005-500

    Afula, 1834111

  • Local Institution - 005-501

    Beer Yaakov, 7030000

  • Local Institution - 005-504

    Beersheba, 84101

  • Local Institution - 005-502

    Holon, 5822012

  • Local Institution - 005-507

    Jerusalem, 9103102

  • Local Institution - 005-506

    Ramat Gan, 5265601

  • Local Institution - 005-505

    Zsfat, 1311001

Other trials in Israel

Switzerland4 sites

  • Inselspital Universitatsspital Bern

    Bern, 3010

  • Hopitaux Universitaires de Geneve

    Geneva, 1205

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne, 1011

  • Kantonsspital Winterthur

    Winterthur, 8401

Other trials in Switzerland

About this study

Official title: A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy SAPPHIRE

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.

Read the detailed description

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.

Being tested
Nivolumab, Sitravatinib, Docetaxel
Keywords
Sitravatinib, Nivolumab, Docetaxel, Checkpoint inhibitor, MGCD516, NSCLC, SAPPHIRE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called Opdivo

    Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.

  • SitravatinibDrug

    Also called MGCD516

    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.

Study groups in NCT03906071
Study groupRoleWhat they receive
Nivolumab and SitravatinibExperimentalNivolumab 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.
Receives: Biological: Nivolumab; Drug: Sitravatinib
DocetaxelActive comparatorDocetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (13)

  1. 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).

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 months)

  4. 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.

    Measured: From first dose up to 28 days post last dose (Up to an average of 7.5 months and maximum of 59 months)

  5. 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.

    Measured: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 months)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: From randomization until disease progression or start of new anti-cancer therapy (Up to approximately 74 months)

  8. 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.

    Measured: From randomization to the date of the first documentation of objective disease progression or death due to any cause (Up to approximately 74 months)

  9. 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).

    Measured: At 12 months from first dose

  10. 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).

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

  11. 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.

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

  12. 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.

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

  13. Sitravatinib Plasma Concentration by Time Point

    Sitravatinib plasma concentration by time point. 1 cycle = 28 days.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2019
  2. Study start15 Jul 2019
  3. Primary completion20 Mar 2023
  4. Study completion30 Sep 2025

Why it stopped: Inability to meet protocol objectives

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
577 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03906071
Sponsor's protocol ID
CA248-0001
Other IDs
CA248-0001, 516-005
Acronym
SAPPHIRE
Status last verified
Aug 2026
First submitted
4 Apr 2019
Last updated
30 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Sitravatinib and Docetaxel in people with Metastatic Non-Squamous Non-Small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 261 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 261 sites in United States, Spain, France, Germany, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization date to date of death due to any cause (Up to approximately 44 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03906071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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