Lung Cancer Clinical Trial
A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy
Summary
This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
Full Description
This study will consist of two treatment arms (Groups A and B).
Participants will be randomised in a 1:1 ratio to one of the two treatment groups:
Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously.
Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
Documented radiological PD whilst on or after receiving the most recent treatment regimen.
Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
Adequate organ function and marrow reserve
Minimum life expectancy of 12 weeks.
Body weight > 30 kg and no cancer-associated cachexia.
Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).
Exclusion Criteria:
Participant with mixed SCLC and NSCLC histology.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
Active or prior documented autoimmune or inflammatory disorders.
Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
Participants:
Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.
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There are 196 Locations for this study
Chandler Arizona, 85224, United States
Corona California, 92882, United States
Los Angeles California, 90017, United States
Miami Florida, 33136, United States
Orlando Florida, 32804, United States
Atlanta Georgia, 30318, United States
Baltimore Maryland, 21231, United States
Rockville Maryland, 20852, United States
Hattiesburg Mississippi, 39401, United States
Winston-Salem North Carolina, 27103, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44106, United States
Allentown Pennsylvania, 18103, United States
Greenville South Carolina, 29605, United States
Houston Texas, 77090, United States
Kingwood Texas, 77339, United States
Lacey Washington, 98503, United States
Buenos Aires , 1058, Argentina
Caba , C1280, Argentina
Cordoba , 5000, Argentina
Pergamino , B2700, Argentina
Rosario , S2000, Argentina
San Juan , 5400, Argentina
Viedma , R8500, Argentina
Elizabeth Vale , 5112, Australia
Murdoch , 6150, Australia
South Brisbane , 4101, Australia
Wendouree , 3355, Australia
Wollongong , 2500, Australia
Charleroi , 6000, Belgium
Gent , 9000, Belgium
Libramont-Chevigny , 6800, Belgium
Roeselare , 8800, Belgium
Fortaleza , 60810, Brazil
Porto Alegre , 90110, Brazil
Porto Alegre , 90610, Brazil
Salvador , 40170, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 09323, Brazil
São Paulo , 04014, Brazil
Vancouver British Columbia, VSZ 4, Canada
Newmarket Ontario, L3Y 2, Canada
Chicoutimi Quebec, G7H 7, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H3G 1, Canada
Rimouski Quebec, G5L 5, Canada
Quebec , G1V 4, Canada
Baoding , 07100, China
Beijing , 10002, China
Beijing , 10004, China
Changsha , 41000, China
Changsha , 41001, China
Chengdu , 61004, China
Chongqing , 40001, China
Deyang , 61800, China
Ganzhou , 34100, China
Guangzhou , 51008, China
Hefei , 23000, China
Jinan , 25001, China
Linyi , 27600, China
Nanchang , 33000, China
Nanjing , 21002, China
Nanning , 53002, China
Qingdao , 26607, China
Taiyuan , 03000, China
Taiyuan , 03000, China
Tianjin , 30005, China
Tianjin , 30006, China
Wuhan , 43000, China
Wuhan , 43002, China
Wuhan , 43007, China
Xingtai , 05400, China
Yantai , 26400, China
Zhanjiang , 52400, China
Zhengzhou , 45000, China
Zhengzhou , 45000, China
Angers , 49933, France
Clamart Cedex , 92140, France
Clermont Ferrand , 63011, France
Creteil , 94010, France
Lyon , 69373, France
Montpellier , 34070, France
Nantes cedex 1 , 44093, France
Paris , 75005, France
Paris , 75014, France
Pessac , 33604, France
Saint Herblain Cedex , 44805, France
Saint-Quentin cedex , 02321, France
Vantoux , 57070, France
Villefranche Sur Saone , 69655, France
Villejuif Cedex , 94805, France
Berlin , 12351, Germany
Freiburg , 79106, Germany
Gauting , 82131, Germany
Karlsruhe , 76137, Germany
Kempten , 87439, Germany
Löwenstein , 74245, Germany
Moers , 47441, Germany
Münster , 48147, Germany
Ulm , 89081, Germany
Hong Kong , , Hong Kong
King's Park , 15000, Hong Kong
Tun Mun , , Hong Kong
Budapest , 1121, Hungary
Székesfehérvár , 8000, Hungary
Törökbálint , 2045, Hungary
Zalaegerszeg , 8900, Hungary
Jaipur , 30201, India
Pune , 41100, India
Surat , 39500, India
Dublin 4 , , Ireland
Dublin , 7, Ireland
Dublin , D09 V, Ireland
Aviano , 33081, Italy
Catania , 95123, Italy
Livorno , 57124, Italy
Meldola , 47014, Italy
Milano , 20133, Italy
Monza , 20900, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Parma , 43126, Italy
Rozzano , 20089, Italy
Verona , 37126, Italy
Bunkyo-ku , 113-8, Japan
Chuo-ku , 104-0, Japan
Hiroshima-shi , 730-8, Japan
Kurashiki-shi , 710-8, Japan
Kurume-shi , 830-0, Japan
Matsuyama-shi , 791-0, Japan
Nagasaki-shi , 852-8, Japan
Nagoya-shi , 460-0, Japan
Niigata-shi , 951-8, Japan
Osaka-shi , 541-8, Japan
Sakai-shi , 591-8, Japan
Sapporo-shi , 003-0, Japan
Sendai-shi , 980-0, Japan
Sunto-gun , 411-8, Japan
Toyoake-shi , 470-1, Japan
Yokohama-shi , 236-0, Japan
Yokohama-shi , 240-8, Japan
Yokohama-shi , 241-8, Japan
Cheongju-si , 28644, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 07061, Korea, Republic of
Seoul , 13620, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Suwon , 16247, Korea, Republic of
Rotterdam , 3015 , Netherlands
Tilburg , 5022 , Netherlands
Zutphens , 7207 , Netherlands
Gdansk , 80-95, Poland
Gdańsk , 80-21, Poland
Krakow , 30-51, Poland
Kraków , 31-82, Poland
Poznan , 60-69, Poland
Skórzewo , 60-18, Poland
Toruń , 87-10, Poland
Bucuresti , 02232, Romania
Bucuresti , 03142, Romania
Cluj-Napoca , 40001, Romania
Cluj-Napoca , 40064, Romania
Constanta , 90059, Romania
Craiova , 20034, Romania
Craiova , 20038, Romania
Floresti , 40728, Romania
Oradea , 41046, Romania
Timisoara , 30016, Romania
Timisoara , 30023, Romania
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Belgrad , 11000, Serbia
Kragujevac , 34000, Serbia
A Coruña , 15006, Spain
A Coruña , 15009, Spain
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Barcelona , 8003, Spain
Castello de la Plana , 12002, Spain
Cordoba , 14004, Spain
Hospitalet deLlobregat , 08907, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Malaga , 29009, Spain
Orense , 32005, Spain
Palma de Mallorca , 07198, Spain
Pamplona , 31008, Spain
Pozuelo de Alarcon , 28223, Spain
Sabadell , 08208, Spain
Servilla , 41014, Spain
Zaragoza , 50009, Spain
Taichung , 40201, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei City , 11217, Taiwan
Taipei , 10048, Taiwan
Taoyuan City , 333, Taiwan
Yunlin , 640, Taiwan
Bristol , BS2 8, United Kingdom
Guildford , , United Kingdom
Stevenage , SG1 4, United Kingdom
Wirral , CH63 , United Kingdom
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