Metastatic Non-Squamous Non-Small Cell Lung Cancer Clinical Trial
— SAPPHIREOfficial 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
| Verified date | October 2023 |
| Source | Mirati Therapeutics Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 532 |
| Est. completion date | April 30, 2024 |
| Est. primary completion date | March 20, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Algemeen Ziekenhuis Klina | Brasschaat | Antwerp |
| Belgium | Grand Hôpital de Charleroi - Notre Dame | Charleroi | Henegouwen |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | Algemeen Ziekenhuis Maria Middelares | Gent | Oost-Vlaaderen |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | Algemeen Ziekenhuis Delta | Roeselare | West-Vlaanderen |
| Belgium | Algemeen Ziekenhuis Glorieux Ronse | Ronse | East Flanders |
| Belgium | Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne | Yvoir | Namur |
| Canada | Tom Baker Cancer Centre | Calgary | Alberta |
| Canada | Juravinski Cancer Centre | Hamilton | Ontario |
| Canada | Horizon Health Network - The Moncton Hospital | Moncton | New Brunswick |
| Canada | Institut Universitaire de Cardiologie et de Pneumologie de Québec-Universite Laval | Québec | |
| Canada | Saint John Regional Hospital | Saint John | New Brunswick |
| Canada | Saskatoon Cancer Center | Saskatoon | |
| Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
| Canada | Windsor Regional Hospital Cancer Program | Windsor | Ontario |
| France | Hôpital Morvan | Brest | |
| France | Hôpital Louis Pradel | Bron | |
| France | Centre Hospitalier Intercommunal de Créteil | Créteil | |
| France | Centre Georges François Leclerc | Dijon Cedex | |
| France | Centre Hospitalier Le Mans | Le Mans Cedex 9 | |
| France | Centre Hospitalier Universitaire Limoges | Limoges Cedex | |
| France | Centre Léon Bérard | Lyon | |
| France | Institut Paoli-Calmettes | Marseille | |
| France | Hôpital Nord de Marseille | Marseille cedex 20 | |
| France | Institut Régional du Cancer de Montpellier - Val d'Aurelle | Montpellier | |
| France | Hôpital Bichat-Claude-Bernard | Paris Cedex 18 | |
| France | Rouen University Hôpital Charles-Nicolle | Rouen | |
| France | Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec | Saint-Herblain | |
| France | Institut de Cancérologie Strasbourg Europe | Strasbourg | |
| France | Institut Gustave Roussy | Villejuif Cedex | |
| Germany | Evangelische Lungenklinik Berlin | Berlin | |
| Germany | Universitätsklinikum Bonn | Bonn | |
| Germany | KEM. Evang.Kliniken Essen-Mitte gGmbh | Essen | |
| Germany | Asklepios Fachkliniken München-Gauting | Gauting | |
| Germany | LungenClinic Grosshansdorf GmbH | Großhansdorf | Schleswig-Holstein |
| Germany | Martha-Maria Krankenhaus Halle-Dölau gGmbH, Studiensekretariat | Halle | |
| Germany | Klinik Löwenstein gGmbH | Heilbronn | Baden-Württemberg |
| Germany | Klinikverbund Kempten-Oberallgäu - Klinik Immenstadt - Klinikverbund Allgäu gGmbH | Immenstadt | Bayern |
| Germany | Klinikum Kassel | Kassel | |
| Germany | Kliniken der Stadt Köln | Köln | |
| Germany | Universitatsklinikum Schleswig-Holstein-Campus Lubeck | Lübeck | |
| Germany | Universitätsmedizin der Johannes Gutenberg-Universität Mainz - III. Medizinischen Klinik und Poliklinik | Mainz | |
| Germany | Klinikum rechts der Isar der Technischen Universität München | München | |
| Germany | Munchen Klinik Bogenhausen | München | |
| Hungary | Országos Korányi Tbc És Pulmonológiai Intézet | Budapest | |
| Hungary | Országos Onkológiai Intézet | Budapest | |
| Hungary | Semmelweis Egyetem - Pulmonológiai Klinika | Budapest | |
| Hungary | Petz Aladár Megyei Oktató Kórház | Gyor | Gyor-Moson-Sopron |
| Hungary | Intézeti Gyógyszertár | Szombathely | Vas |
| Hungary | Szent Borbála Kórház | Tatabánya | Komárom-Esztergom |
| Hungary | Törökbálinti Tüdogyógyintézet | Törökbálint | |
| Israel | Emek Medical Center | Afula | |
| Israel | Soroka Medical Center | Be'er Sheva | |
| Israel | Shamir Medical Center (Assaf Harofeh) | Be'er Ya'aqov | |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Chaim Sheba Medical Center | Ramat Gan | |
| Israel | Ziv Medical Center | Safed | |
| Israel | The Edith Wolfson Medical Center | Tel Aviv | |
| Italy | Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo | Alessandria | |
| Italy | IRCCS Istituto Tumori "Giovanni Paolo II" | Bari | |
| Italy | Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco" | Catania | |
| Italy | Ospedale di Cremona | Cremona | |
| Italy | ASL Lecce - Ospedale Vito Fazzi | Lecce | |
| Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Forlì-Cesena |
| Italy | Istituto Europeo di Oncologia | Milano | Lombardia |
| Italy | S.C Oncologia Medica, ASST Monza - Ospedale San Gerardo | Monza | |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Napoli | Naples |
| Italy | Azienda Ospedaliero-Universitaria di Parma | Parma | |
| Italy | Ospedale Guglielmo da Saliceto | Piacenza | |
| Italy | Azienda Ospedaliero - Universitaria Pisana | Pisa | |
| Italy | Istituto Nazionale Tumori Regina Elena | Roma | |
| Italy | ASST-SETTE LAGHI, Ospedale di Circolo e Fondazione Macchi | Varese | |
| Netherlands | Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum | Amsterdam | |
| Netherlands | The Netherlands Cancer Institute | Amsterdam | Noord-Holland |
| Netherlands | Amphia Ziekenhuis - Breda Molengracht | Breda | |
| Netherlands | Hagaziekenhuis Van Den Haag - Leyweg | Den Haag | Zuid-Holland |
| Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | |
| Netherlands | Martini Ziekenhuis | Groningen | |
| Netherlands | Maastricht Universitair Medisch Centrum | Maastricht | Limburg |
| Netherlands | Ziekenhuis Nieuwegein | Nieuwegein | Utrecht |
| Netherlands | Radboud University Medical Center | Nijmegen | |
| Netherlands | Erasmus Medisch Centrum | Rotterdam | Zuid-Holland |
| Netherlands | Jeroen Bosch Ziekenhuis | s-Hertogenbosch | North Brabant |
| Netherlands | Franciscus Vlietland & Gasthuis | Schiedam | South Holland |
| Netherlands | UMC Utrecht | Utrecht | |
| Netherlands | Isala | Zwolle | Overijssel |
| Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | La Coruña |
| Spain | Institut Català d'Oncologia Badalona, Hospital Universitari Germans Trias i Puj | Badalona | Barcelona |
| Spain | Hospital del Mar - Parc de Salut Mar | Barcelona | |
| Spain | Hospital Universitari Dexeus | Barcelona | |
| Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
| Spain | Complejo Hospitalario de Jaén | Jaén | |
| Spain | Hospital Universitario Insular de Gran Canaria | Las Palmas De Gran Canaria | |
| Spain | Hospital de León | León | |
| Spain | Hospital Universitario Lucus Augusti | Lugo | |
| Spain | Clinica Universidad de Navarra - Madrid | Madrid | |
| Spain | Complejo Hospitalario Ruber Juan Bravo | Madrid | |
| Spain | Hospital Clinico San Carlos | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario La Princesa | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Regional Universitario de Málaga - Hospital Civil | Málaga | Malaga |
| Spain | Hospital Universitario Central de Asturias | Oviedo | |
| Spain | Hospital Clínico Universitario de Santiago de Compostela | Santiago De Compostela | A Coruña |
| Spain | Fundacion Instituto Valenciano de Oncologia | Valencia | |
| Spain | Hospital Universitari i Politècnic La Fe | Valencia | |
| Spain | Hospital Alvaro Cunqueiro - Clinico Universitario Vigo | Vigo | |
| Switzerland | HUG: hopitaux universitaires de genève | Genève | |
| Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
| Switzerland | Kantonsspital Winterthur | Winterthur | |
| United Kingdom | Velindre University NHS Trust | Cardiff | |
| United Kingdom | University Hospitals of Leicester NHS Trust | Leicester | |
| United Kingdom | Barts Health NHS Trust | London | |
| United Kingdom | Royal Free London NHS Foundation Trust | London | |
| United Kingdom | The Royal Marsden NHS Foundation Trust | London | |
| United Kingdom | East and North Hertfordshire NHS Trust | Northwood | Middlesex |
| United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | |
| United Kingdom | Royal Cornwall Hospital NHS Trust | Truro | Cornwall |
| United Kingdom | The Christie NHS Foundation Trust | Withington | Manchester |
| United States | ThedaCare Regional Cancer Center | Appleton | Wisconsin |
| United States | University Cancer and Blood Center - LLC - Athens | Athens | Georgia |
| United States | Piedmont Cancer Institute | Atlanta | Georgia |
| United States | Texas Oncology - South Austin | Austin | Texas |
| United States | Comprehensive Blood and Cancer Center - Bakersfield | Bakersfield | California |
| United States | Texas Oncology - Beaumont Mamie Mcfaddin Ward Cancer Center | Beaumont | Texas |
| United States | Beverly Hills Cancer Center | Beverly Hills | California |
| United States | St. Vincent Frontier Cancer Center | Billings | Montana |
| United States | Alabama Oncology - Grandview | Birmingham | Alabama |
| United States | Central Care Cancer Center - Bolivar | Bolivar | Missouri |
| United States | Mercy Hematology & Oncology Associates | Canton | Ohio |
| United States | University of Virginia Cancer Center | Charlottesville | Virginia |
| United States | Oncology Hematology Care - Blue Ash | Cincinnati | Ohio |
| United States | Beacon Cancer Care | Coeur d'Alene | Idaho |
| United States | John B. Amos Cancer Center Research | Columbus | Georgia |
| United States | The Ohio State University College of Medicine | Columbus | Ohio |
| United States | The Oncology Institute of Hope and Innovation - Corona | Corona | California |
| United States | Pontchartrain Cancer Center - Covington Office | Covington | Louisiana |
| United States | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas |
| United States | Texas Oncology - Methodist Dallas Cancer Center | Dallas | Texas |
| United States | Commonwealth Cancer Center | Danville | Kentucky |
| United States | Texas Oncology - Denton South | Denton | Texas |
| United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Evanston Hospital | Evanston | Illinois |
| United States | Providence Regional Center Partnership | Everett | Washington |
| United States | Summit Medical Group - Florham Park Campus | Florham Park | New Jersey |
| United States | Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida |
| United States | Florida Cancer Specialists & Research Institute | Fort Myers | Florida |
| United States | Fort Wayne Medical Oncology and Hematology - Fort Wayne South Office | Fort Wayne | Indiana |
| United States | The Center for Cancer & Blood Disorders - Fort Worth | Fort Worth | Texas |
| United States | Hematology Oncology Associates of Fredericksburg | Fredericksburg | Virginia |
| United States | Saint Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center | Fullerton | California |
| United States | Palo Verde Cancer Specialists - Glendale | Glendale | Arizona |
| United States | Goshen Center for Cancer Care | Goshen | Indiana |
| United States | Sisters of Charity of Leavenworth Health St. Mary's | Grand Junction | Colorado |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | Memorial Regional Hospital | Hollywood | Florida |
| United States | Straub Medical Center | Honolulu | Hawaii |
| United States | USOR - Consultants in Medical Oncology and Hematology PC - Abington Hematology/Oncology Associates | Horsham | Pennsylvania |
| United States | Millennium Physicians - North Houston | Houston | Texas |
| United States | Texas Oncology - Houston Willowbrook | Houston | Texas |
| United States | Clearview Cancer Institute | Huntsville | Alabama |
| United States | Franciscan Health Indianapolis | Indianapolis | Indiana |
| United States | Jackson Oncology Associates | Jackson | Mississippi |
| United States | Broome Oncology | Johnson City | New York |
| United States | NEA Baptist Fowler Family Center for Cancer Care | Jonesboro | Arkansas |
| United States | Saint Bernards Medical Center | Jonesboro | Arkansas |
| United States | Kansas City Care Health Center - Research Medical Campus | Kansas City | Missouri |
| United States | Good Samaritan Medical Center | Lafayette | Colorado |
| United States | Indiana University Health Arnett Cancer Care | Lafayette | Indiana |
| United States | Monter Cancer Center | Lake Success | New York |
| United States | Watson Clinic Cancer & Research Center | Lakeland | Florida |
| United States | Regional Cancer Care Associates - Little Silver | Little Silver | New Jersey |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Cancer and Blood Specialty Clinic | Los Alamitos | California |
| United States | Los Angeles Hematology Oncology Medical Group | Los Angeles | California |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center | Los Angeles | California |
| United States | Norton Cancer Institute - Broadway | Louisville | Kentucky |
| United States | University Wisconsin Carbone Cancer Center | Madison | Wisconsin |
| United States | Northwest Georgia Oncology Centers - Marietta | Marietta | Georgia |
| United States | Tricounty Hematology and Oncology- Massillon | Massillon | Ohio |
| United States | Texas Oncology - McKinney | McKinney | Texas |
| United States | Baptist Cancer Center - Memphis | Memphis | Tennessee |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | Froedtert Hospital - Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | SCRI - Tennessee Oncology - Nashville - Centennial | Nashville | Tennessee |
| United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
| United States | Illinois Cancer Specialists - Niles | Niles | Illinois |
| United States | Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut |
| United States | Florida Cancer Affiliates - Ocala - Main | Ocala | Florida |
| United States | Mercy Clinic Oncology and Hematology - Coletta | Oklahoma City | Oklahoma |
| United States | Methodist Hospital - Omaha | Omaha | Nebraska |
| United States | Cancer Institute of Florida - Orlando | Orlando | Florida |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | BRCR Medical Center Inc | Plantation | Florida |
| United States | New York Cancer & Blood Specialists | Port Jefferson Station | New York |
| United States | Oregon Health and Science University Knight Cancer Institute | Portland | Oregon |
| United States | Providence Cancer Institute Franz Clinic | Portland | Oregon |
| United States | Redlands Hematology Oncology | Redlands | California |
| United States | Virginia Cancer Institute - Reynolds Crossing | Richmond | Virginia |
| United States | Maryland Oncology Hematology - Rockville Aquilino Cancer Center | Rockville | Maryland |
| United States | Park Nicollet - Frauenshuh Cancer Center | Saint Louis Park | Minnesota |
| United States | Texas Oncology - San Antonio | San Antonio | Texas |
| United States | University of California San Francisco | San Francisco | California |
| United States | California Cancer Associates for Research and Excellence - San Marcos | San Marcos | California |
| United States | SCRI - Florida Cancer Specialists - North Region Research Office | Sarasota | Florida |
| United States | New England Cancer Specialists | Scarborough | Maine |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Texas Oncology - Sherman | Sherman | Texas |
| United States | Orchard Healthcare Research Inc. | Skokie | Illinois |
| United States | Cancer Care Northwest - North Spokane | Spokane | Washington |
| United States | Highlands Oncology Group - Springdale | Springdale | Arkansas |
| United States | Stony Brook University Cancer Center | Stony Brook | New York |
| United States | Texas Oncology - Sugar Land | Sugar Land | Texas |
| United States | MultiCare Institute for Research & Innovation | Tacoma | Washington |
| United States | Northwest Medical Specialties, PLLC | Tacoma | Washington |
| United States | SCRI - Florida Cancer Specialists - Panhandle Research Office | Tallahassee | Florida |
| United States | The Oncology Institute of Hope and Innovation - Thousand Oaks | Thousand Oaks | California |
| United States | Toledo Clinic Cancer Center | Toledo | Ohio |
| United States | Torrance Memorial Physician Network - Cancer Care and Infusion Center | Torrance | California |
| United States | The Oncology Institute of Hope and Innovation - Tucson | Tucson | Arizona |
| United States | Texas Oncology - Tyler | Tyler | Texas |
| United States | Northwest Cancer Specialists | Vancouver | Washington |
| United States | Brian J. LeBerthon M.D. | West Covina | California |
| United States | SCRI - Florida Cancer Specialists - West Palm Beach | West Palm Beach | Florida |
| United States | The Richard and Annette Bloch Cancer Care Pavilion and Westwood Medical Pavilion | Westwood | Kansas |
| United States | The Oncology Institute of Hope and Innovation - Whittier | Whittier | California |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| United States | Yuma Regional Medical Center | Yuma | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Mirati Therapeutics Inc. | Bristol-Myers Squibb |
United States, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS is defined as time from date of randomization to date of death due to any cause | 36 Months | |
| Secondary | Adverse Events (AEs) | Frequency of patients experiencing treatment-emergent AEs | 36 Months | |
| Secondary | Objective Response Rate (ORR) | ORR defined as 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 | 36 Months | |
| Secondary | Progression-Free Survival (PFS) | 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 | 36 months |