Lung Cancer Clinical Trial
A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Summary
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
Eligibility Criteria
INCLUSION CRITERIA:
Participant must be ≥ 18 years at the time of screening.
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
Provision of a tumour tissue sample obtained prior to CRT
Documented tumour PD-L1 status by central lab
Documented EGFR and ALK wild-type status (local or central).
Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
WHO performance status of 0 or 1 at randomization
Adequate organ and marrow function
EXCLUSION CRITERIA:
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 and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
Mixed small cell and non-small cell lung cancer histology.
Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization.
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
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There are 200 Locations for this study
San Diego California, 92123, United States
New Haven Connecticut, 06510, United States
Stuart Florida, 34994, United States
Urbana Illinois, 61801, United States
Waterloo Iowa, 50703, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40241, United States
Scarborough Maine, 04074, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21229, United States
Grand Rapids Michigan, 49503, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55812, United States
Billings Montana, 59101, United States
Ridgewood New Jersey, 07450, United States
Middletown New York, 10941, United States
Greensboro North Carolina, 27403, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Sioux Falls South Dakota, 57105, United States
Charlottesville Virginia, 22908, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23235, United States
Richland Washington, 99352, United States
Spokane Washington, 99204, United States
Tacoma Washington, 98405, United States
Milwaukee Wisconsin, 53226, United States
Box Hill , 3128, Australia
East Melbourne , 3002, Australia
Elizabeth Vale , 5112, Australia
Gosford , 2250, Australia
Heidelberg , 3084, Australia
Kogarah , 2217, Australia
South Brisbane , 4101, Australia
St Albans , 3021, Australia
St. Leonards , 2065, Australia
Westmead , 2145, Australia
Belo Horizonte , 30380, Brazil
Florianópolis , 88034, Brazil
Jaú , 17210, Brazil
Porto Alegre , 90610, Brazil
Porto Alegre , 91350, Brazil
Recife , 52010, Brazil
Sao Paulo , 01323, Brazil
Uberlândia , 38408, Brazil
Vitoria , 29043, Brazil
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 2, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 2, Canada
Anyang , 45500, China
Beijing , 10002, China
Beijing , , China
Changchun , 13002, China
Changsha , 41000, China
Changsha , 41001, China
Chongqing , 40001, China
Guangzhou , 51006, China
Guangzhou , 51006, China
Guangzhou , 51070, China
Hangzhou , 31000, China
Hangzhou , 31002, China
Hefei , 13350, China
Hefei , 23003, China
Kunming , 65011, China
Linhai , 31700, China
Nanchang , 33000, China
Nanning , 53002, China
Nantong , 22636, China
Neijiang , 64100, China
Ningbo , 31510, China
Shanghai , 20043, China
Shaoguan , 51202, China
Shenyang , 11004, China
Tianjin , 30006, China
Wuhan , 43002, China
Wuhan , 43007, China
Wuhan , 43007, China
Zhanjiang , 52400, China
Zhengzhou City , 45000, China
Zhengzhou , 45000, China
Zhongshan , 52840, China
Zhuhai , 51900, China
Barranquilla , 08001, Colombia
Barranquilla , 08002, Colombia
Bogotá , , Colombia
Medellin , 05003, Colombia
Valledupar , 20000, Colombia
Avignon Cedex 9 , 84918, France
Besançon Cedex , 25030, France
Bordeaux , 33075, France
Clermont-Ferrand , 63000, France
Creteil Cedex , 94010, France
Lorient cedex , 56322, France
Marseille Cedex 20 , 13015, France
Montpellier , 34298, France
Paris Cedex 5 , 75005, France
Rennes Cedex 9 , 35033, France
Rouen , 76031, France
Toulouse CEDEX 09 , 31059, France
Villejuif Cedex , 94805, France
Erfurt , 99089, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Esslingen , 73730, Germany
Georgsmarienhuette , 49124, Germany
Guetersloh , 33332, Germany
Hannover , 30459, Germany
Oldenburg , 26121, Germany
Würzburg , 97080, Germany
Brescia , 25123, Italy
Firenze , 50134, Italy
Lucca , 55100, Italy
Meldola , 47014, Italy
Orbassano , 10043, Italy
Parma , 43126, Italy
Pavia , 27100, Italy
Roma , 00128, Italy
Himeji-shi , 670-8, Japan
Hiroshima-shi , 730-0, Japan
Kashiwa , 227-8, Japan
Kurume-shi , 830-0, Japan
Natori-shi , 981-1, Japan
Niigata-shi , 951-8, Japan
Osaka-shi , 541-8, Japan
Sendai-shi , 980-0, Japan
Tokushima-shi , 770-8, Japan
Toon-shi , 791-0, Japan
Wakayama-shi , 641-8, Japan
Changwon-si , 51353, Korea, Republic of
Cheongju-si , 28644, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Suwon-si , 16499, Korea, Republic of
Suwon , 16247, Korea, Republic of
Concepción , 12125, Peru
Lima , 15036, Peru
Lima , LIMA , Peru
Lima , LIMA , Peru
Lima , Lima , Peru
Lima , Lima , Peru
Trujillo , , Peru
Brzozów , 36-20, Poland
Bydgoszcz , 85-79, Poland
Gdańsk , 80-95, Poland
Koszalin , 75-58, Poland
Siedlce , 08-11, Poland
Tomaszów Mazowiecki , 97-20, Poland
Warszawa , 02-78, Poland
Lisboa , 1099-, Portugal
Lisboa , 1400-, Portugal
Lisboa , 1769-, Portugal
Lisboa , 1998-, Portugal
Loures , 2674-, Portugal
Porto , 4200-, Portugal
Novosibirsk , 63009, Russian Federation
Yekaterinburg , 62003, Russian Federation
Barcelona , 08035, Spain
Barcelona , 8003, Spain
Granada , 18016, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Santiago de Compostela , 15706, Spain
Valencia , 46010, Spain
Hsinchu , 300, Taiwan
Taichung , 402, Taiwan
Taichung , 40705, Taiwan
Taipei 112 , , Taiwan
Taipei , 11490, Taiwan
Taipei , 23561, Taiwan
Taoyuan City , 333, Taiwan
Bangkok , 10300, Thailand
Bangkok , 10700, Thailand
Hat Yai , 90110, Thailand
Khon Kaen , 40000, Thailand
Khon Kaen , 40002, Thailand
Lampang , 52000, Thailand
Muang , 22000, Thailand
Muang , 50200, Thailand
Mueang , 20000, Thailand
Naimuang , 30000, Thailand
Ankara , 06010, Turkey
Ankara , 06230, Turkey
Ankara , 06800, Turkey
Diyarbakir , 21280, Turkey
Goztepe Istanbul , , Turkey
Karsiyaka , 35575, Turkey
Chernihiv , 14029, Ukraine
Kharkiv Region , 61018, Ukraine
Kropyvnytskyi , 25011, Ukraine
Kyiv , 03680, Ukraine
Uzhgorod , 88000, Ukraine
Zaporizhzhia , 69000, Ukraine
Belfast , BT9 7, United Kingdom
Bristol , BS2 8, United Kingdom
Dundee , DD1 9, United Kingdom
Edinburgh , EH4 2, United Kingdom
Hampshire , SO16 , United Kingdom
London , NW1 2, United Kingdom
London , W6 8R, United Kingdom
Middlesbrough , TS4 3, United Kingdom
Poole , BH15 , United Kingdom
Rhyl , LL18 , United Kingdom
Torquay , TQ2 7, United Kingdom
Truro , TR1 3, United Kingdom
Wolverhampton , WV10 , United Kingdom
Hanoi , 10000, Vietnam
Ho Chi Minh city , 70000, Vietnam
Ho Chi Minh City , 70000, Vietnam
Ho Chi Minh , 70000, Vietnam
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