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The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daraxonrasib | Experimental | study drug |
|
| docetaxel | Active Comparator | Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daraxonrasib | Drug | oral tablets |
| |
| docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C) | PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by BICR. | Up to approximately 4 years |
| Overall survival (OS) in the RAS G12X-C population | OS is defined as the time from randomization until death from any cause. | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS in the RAS (MUT) population per BICR | PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by BICR. | Up to approximately 4 years |
| OS in the RAS (MUT) population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Revolution Medicines Study Director | Contact | 1-844-2-REVMED | medinfo@revmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Recruiting | Birmingham | Alabama | 35243 | United States |
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The central reader of the tumor scans will be masked to the patients' treatment arm.
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| Drug |
intravenous (IV) infusion |
|
OS is defined as time from randomization until death from any cause. |
| up to approximately 4 years |
| Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations | Objective response of partial response (PR) or complete response (CR) per RECIST v1.1 as assessed by BICR. | Up to approximately 4 years |
| PFS per Investigator in the RAS (G12X-C) and RAS (MUT) populations | PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by Investigator. | Up to approximately 4 years |
| Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations | Objective response of PR or CR per RECIST v1.1 as assessed by Investigator. | Up to approximately 4 years |
| Duration of response (DOR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations | DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator and by BICR. | Up to approximately 4 years |
| Time to response (TTR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations | TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by Investigator and by BICR. | Up to approximately 4 years |
| Treatment effect on quality of life (QoL) using EORTC QLQ-LC13 In the RAS (G12X-C) and RAS (MUT) populations | Time to deterioration (TTD) in selected symptoms (dyspnea, chest pain, cough) defined as the time from randomization to the first onset of 10 points or more deterioration from baseline in the corresponding symptom scales (dyspnea, chest pain, cough) on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13). Change from baseline on EORTC QLQ-LC13 in symptom scales (dyspnea, cough, chest pain). | Up to approximately 4 years |
| Treatment effect on quality of life (QoL) using EORTC QLQ-C30 In the RAS (G12X-C) and RAS (MUT) populations | Change from baseline in global quality of life score from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) questionnaire. Change from baseline on EORTC QLQ-C30 functioning domains (physical role, cognitive, emotional, social). | Up to approximately 4 years |
| Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population | Incidence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), serious adverse events (SAEs), changes in vital signs and clinical laboratory tests. | Up to approximately 4 years |
| PK characterization of daraxonrasib In the RAS (MUT) population | Predose and post-dose blood concentrations of daraxonrasib over time. | Up to approximately 4 years |
| MemorialCare Long Beach Medical Center | Recruiting | Long Beach | California | 90806 | United States |
|
| Yale University, Smillow Cancer Center | Recruiting | New Haven | Connecticut | 06519 | United States |
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| Florida Cancer Specialists & Research Institute - South | Recruiting | Fort Myers | Florida | 33901 | United States |
|
| BRCR Global | Recruiting | Plantation | Florida | 33322 | United States |
|
| Cancer Care Centers of Breevard | Recruiting | Rockledge | Florida | 32955 | United States |
|
| Florida Cancer Specialists & Research Institute - North | Recruiting | St. Petersburg | Florida | 33705 | United States |
|
| Cleveland Clinic Martin North | Recruiting | Stuart | Florida | 34994 | United States |
|
| Florida Cancer Specialists & Research Institute - East | Recruiting | West Palm Beach | Florida | 33401 | United States |
|
| University Cancer and Blood Center | Recruiting | Athens | Georgia | 30607 | United States |
|
| Piedmont Healthcare, Inc | Recruiting | Atlanta | Georgia | 30318 | United States |
|
| Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Center for Care and Discovery | Recruiting | Chicago | Illinois | 60637 | United States |
|
| University of Iowa Health Care Cancer Services Quad Cities | Recruiting | Bettendorf | Iowa | 52722 | United States |
|
| University of Iowa Hospitals & Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| University of Iowa Health Care, Mission Cancer + Blood | Recruiting | Waukee | Iowa | 50263 | United States |
|
| The University of Kansas Cancer Center | Recruiting | Westwood | Kansas | 66205 | United States |
|
| Johns Hopkins University of Medicine | Recruiting | Baltimore | Maryland | 21224 | United States |
|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
|
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Washington University School of Medicine - Siteman Cancer Center | Recruiting | St Louis | Missouri | 63110 | United States |
|
| St. Vincent Frontier Cancer Center | Recruiting | Billings | Montana | 59102 | United States |
|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
|
| John Theurer Cancer Center at Hackensack UMC | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Morristown Medical Center (MMCORC) | Recruiting | Morristown | New Jersey | 07960 | United States |
|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
|
| UNC Lineberger Comprehensive Cancer Center at University of North Carolina | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| TriHealth Cancer & Blood Institute Research | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| Taylor Cancer Research Center | Recruiting | Maumee | Ohio | 43537 | United States |
|
| Oncology Associates of Oregon PC | Recruiting | Eugene | Oregon | 97401 | United States |
|
| Penn State Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
|
| Avera Saint Luke's Hospital | Recruiting | Aberdeen | South Dakota | 57401 | United States |
|
| Avera Cancer Institute | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
|
| SCRI Oncology Partners - Tennessee | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Texas Oncology - South Austin | Recruiting | Austin | Texas | 78745 | United States |
|
| Texas Oncology Dallas | Recruiting | Dallas | Texas | 75251 | United States |
|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Texas Oncology - Gulf Coast | Recruiting | The Woodlands | Texas | 77380 | United States |
|
| Utah Cancer Specialists | Recruiting | Salt Lake City | Utah | 84106 | United States |
|
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| Blacktown Medical Oncology Research, Blacktown Hospital | Recruiting | Blacktown | New South Wales | 2148 | Australia |
|
| Blacktown Medical Oncology Research | Recruiting | Blacktown | New South Wales | 2148 | Australia |
|
| Chris O'Brien Lifehouse | Recruiting | Camperdown | New South Wales | 2050 | Australia |
|
| St. George Private Hospital Clinical Trials Unit | Recruiting | Kogarah | New South Wales | 2217 | Australia |
|
| Calvary Mater Newcastle | Recruiting | Waratah | New South Wales | 2298 | Australia |
|
| Mater Misericordiae Limited | Recruiting | South Brisbane | Queensland | 4101 | Australia |
|
| Alfred House | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| Sir Charles Gairdner Hospital | Recruiting | Perth | Western Australia | 6009 | Australia |
|
| Institut Jules Bordet | Recruiting | Anderlecht | Belgium | 1070 | Belgium |
|
| Grand Hôpital de Charleroi - Les Viviers | Recruiting | Gilly | 6060 | Belgium |
|
| AZ Groeninge | Recruiting | Kortrijk | 8500 | Belgium |
|
| UZ Leuven-Campus Gasthuisberg | Recruiting | Leuven | 3000 | Belgium |
|
| AZ Delta | Recruiting | Roeselare | 8800 | Belgium |
|
| CHU Strasbourg - Nouvel Hôpital Civil | Recruiting | Strasbourg | Bas Rhin | 67091 | France |
|
| Hopital Nord - CHU Marseille | Recruiting | Marseille | Bouches-du-Rhône | 13915 | France |
|
| Institut régional du Cancer de Montpellier | Recruiting | Montpellier | Herault | 34298 | France |
|
| CHU Rennes Hôpital Pontchaillou | Recruiting | Rennes | Ille et Vilaine | 35033 | France |
|
| CHU de Grenoble - Hôpital Albert Michallon | Recruiting | La Tronche | Isere | 38700 | France |
|
| CHU Nantes - Hôpital Guillaume et René Laënnec | Recruiting | Saint-Herblain | Loire Atlantique | 44805 | France |
|
| Institut de Cancerologie de l Ouest | Recruiting | Saint-Herblain | Loire Atlantique | 44805 | France |
|
| Centre Leon Berard | Recruiting | Léon | Lyon | 69008 | France |
|
| Hopital Albert Calmette - CHU Lille | Recruiting | Lille | Nord | 59037 | France |
|
| Hôpital Bichat - Claude Bernard | Recruiting | Paris | Paris | 75018 | France |
|
| Hopital Louis Pradel | Recruiting | Bron | Rhone | 69677 | France |
|
| Centre Hospitalier Intercommunal de Créteil | Recruiting | Créteil | Val de Marne | 94000 | France |
|
| Institut Gustave Roussy | Recruiting | Vaillant | Villejuif | 94800 | France |
|
| CHU Brest - Hôpital Morvan | Recruiting | Brest | 29200 | France |
|
| Institut Bergonie | Recruiting | Gironde | 33076 | France |
|
| CHU de Toulouse - Hopital Larrey | Recruiting | Toulouse | 31059 | France |
|
| LKI Lungenfachklinik Immenhausen | Recruiting | Immenhausen | Hesse | 34376 | Germany |
|
| Universitaetsklinikum Essen | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
|
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
|
| Thoraxklinik Heidelberg gGmbH | Recruiting | Baden | Wuerttemberg | 69469 | Germany |
|
| Klinikum Esslingen GmbH | Recruiting | Baden | 73730 | Germany |
|
| Evangelische Lungenklinik Berlin | Recruiting | Berlin | 13125 | Germany |
|
| Hong Kong United Oncology Centre | Recruiting | Hong Kong | Hong Kong |
|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
|
| The Chinese University of Hong Kong | Recruiting | Shatin | 00000 | Hong Kong |
|
| Cork Univeristy Hospital | Recruiting | Cork | Cork | T12 DC4A | Ireland |
|
| Mater Private Hospital | Recruiting | Dublin | Dublin | 7 | Ireland |
|
| University Hospital Limerick | Recruiting | Cork | Limerick | V94 F858 | Ireland |
|
| Tallaght University Hospital | Recruiting | Dublin | 24 | Ireland |
|
| Beaumont Hospital Cancer Clinical | Recruiting | Dublin | D09 V2N0 | Ireland |
|
| Galway University Hospital | Recruiting | Galway | H91 YR71 | Ireland |
|
| IEO Istituto Europeo di Oncologia | Recruiting | Milan | Milano | 20141 | Italy |
|
| Azienda Socio Sanitaria Territoriale Niguarda | Recruiting | Milan | Milano | 21206 | Italy |
|
| Istituto Clinico Humanitas | Recruiting | Rossano | Milano | 20089 | Italy |
|
| Fondazione IRCCS San Gerardo dei Tintori | Recruiting | Monza | Milan | 20900 | Italy |
|
| Istituto Nazionale Tumori Fondazione G. Pascale | Recruiting | Naples | Napoli | 80131 | Italy |
|
| Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) | Recruiting | Pisa | Pisa | 56124 | Italy |
|
| Istituto Nazionale dei Tumori Regina Elena IRCCS | Recruiting | Roma | Roma | 00144 | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
|
| Aichi Cancer Center Hospital | Recruiting | Nagoya | Aichi-ken | 464-8681 | Japan |
|
| Fujita Health University Hospital | Recruiting | Toyoake-shi | Aichi-ken | 470-1192 | Japan |
|
| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
|
| NHO Himeji Medical Center | Recruiting | Matsuyama | Ehime | 791-0280 | Japan |
|
| NHO Shikoku Cancer Center | Recruiting | Matsuyama | Ehime | 791-0280 | Japan |
|
| National Hospital Organization Hokkaido Cancer Center | Recruiting | Sapporo | Hokkaido | 003-0804 | Japan |
|
| Hyogo Cancer Center | Recruiting | Akashi | Hyōgo | 673-8558 | Japan |
|
| Kanazawa University Hospital | Recruiting | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
|
| Kanagawa Cancer Center | Recruiting | Yokohama | Kanagawa | 241-8515 | Japan |
|
| Tohoku University Hospital | Recruiting | Sendai | Miyagi | 980-8574 | Japan |
|
| Sendai Kousei Hospital | Recruiting | Sendai | Miyagi | 981-0914 | Japan |
|
| Nara Medical University Hospital | Recruiting | Kashihara-shi | Nara | 634-8522 | Japan |
|
| Niigata Cancer Center | Recruiting | Niigata | Niigata | 951-8566 | Japan |
|
| Kansai Medical University Hospital | Recruiting | Hirakata-shi | Osaka | 573-1191 | Japan |
|
| Kindai University Hospital | Recruiting | Osakasayama-shi | Osaka | 589-8511 | Japan |
|
| Shizuoka Cancer Center | Recruiting | Nagaizumi-chō | Shizuoka | 411-8777 | Japan |
|
| National Cancer Center Hospital | Recruiting | Chuo Ku | Tokyo | 104-0045 | Japan |
|
| Cancer Institute Hospital of JFCR | Recruiting | Koto-Ku | Tokyo | 135-8550 | Japan |
|
| Wakayama Medical University Hospital | Recruiting | Wakayama | Wakayama | 641-8510 | Japan |
|
| Amsterdam UMC, Locatie VUMC | Recruiting | Amsterdam | Netherlands | 1081BT | Netherlands |
|
| Erasmus Medisch Centrum | Recruiting | Rotterdam | Netherlands | 3015AA | Netherlands |
|
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | 1066 CX | Netherlands |
|
| Maastricht University Medical Center P. Debyelaan 25 | Recruiting | Maastricht | 6229 | Netherlands |
|
| Radboudumc | Recruiting | Nijmegen | 6525 GA | Netherlands |
|
| Auckland City Hospital - Cancer and Blood Research | Recruiting | Grafton | Auckland | 1023 | New Zealand |
|
| Klinika Onkologii I Radioterapii UCK | Recruiting | Gdansk | 80-214 | Poland |
|
| INSTYTUT GENETYKI I IMMMUNOLOGII GENIM sp. z o.o. | Recruiting | Lublin | 29-609 | Poland |
|
| Med-Polonia Sp. z o.o. | Recruiting | Poznan | 60-693 | Poland |
|
| Aidport Sp. z o.o. | Recruiting | Skorzewo | 60-185 | Poland |
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| Pan American Center for Oncology Trials | Recruiting | San Juan | Puerto Rico | 00909 | Puerto Rico |
|
| National University Hospital | Recruiting | Singapore | Singapore | 119074 | Singapore |
|
| National Cancer Centre Singapore | Recruiting | Singapore | 168583 | Singapore |
|
| Icon Cancer Centre | Recruiting | Singapore | 574623 | Singapore |
|
| Ajou University Hospital | Recruiting | Gyeonggi-do | Suwon-si | 16499 | South Korea |
|
| Chungbuk National University Hospital | Recruiting | Cheongju-si | 28644 | South Korea |
|
| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | 58128 | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
|
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
|
| Complejo Hospitalario Universitario A Coruña | Recruiting | A Coruña | A Coruña | 15006 | Spain |
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| Hospital Universitari Dexeus | Recruiting | Barcelona | Barcelona | 08028 | Spain |
|
| Hospital Universitario La Paz | Recruiting | Fuencarral-El Pardo | Madrid | 28046 | Spain |
|
| Hospital Universitario HM Madrid Sanchinarro | Recruiting | Madrid | Madrid | 28050 | Spain |
|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
|
| Universitätsspital Basel | Recruiting | Basel | 4031 | Switzerland |
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| HFR Fribourg/Kantonsspital Fribourg | Recruiting | Fribourg | 1708 | Switzerland |
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| Kantonsspital St. Gallen | Recruiting | Sankt Gallen | 9000 | Switzerland |
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| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung | Taiwan | 100 | Taiwan |
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| National Cheng Kung University Hospital | Recruiting | Tainan | Taiwan | 704 | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | Taiwan | 10002 | Taiwan |
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| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
|
| Chang Gung Medical Foundation Linkou | Recruiting | Taoyuan | 333 | Taiwan |
|
| Royal Marsden Hospital-London | Recruiting | London | Greater London | SW3 6JJ | United Kingdom |
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| The Clatterbridge Cancer Centre | Recruiting | Liverpool | Merseyside | L7 8YA | United Kingdom |
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| Royal Marsden Hospital-Sutton | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
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| Royal Free Hospital | Recruiting | London | W3 2QG | United Kingdom |
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| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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