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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

999

Study ID:

NCT05221840

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 220 Locations for this study

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San Diego California, 92123, United States
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New Haven Connecticut, 06510, United States
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Stuart Florida, 34994, United States
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Urbana Illinois, 61801, United States
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New Albany Indiana, 47150, United States
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Waterloo Iowa, 50703, United States
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Lexington Kentucky, 40503, United States
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Louisville Kentucky, 40241, United States
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Scarborough Maine, 04074, United States
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Annapolis Maryland, 21401, United States
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Baltimore Maryland, 21201, United States
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Baltimore Maryland, 21229, United States
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Bethesda Maryland, 20817, United States
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Grand Rapids Michigan, 49503, United States
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Duluth Minnesota, 55805, United States
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Duluth Minnesota, 55812, United States
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Billings Montana, 59101, United States
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Ridgewood New Jersey, 07450, United States
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Middletown New York, 10941, United States
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Greensboro North Carolina, 27403, United States
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Cleveland Ohio, 44111, United States
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Cleveland Ohio, 44124, United States
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Cleveland Ohio, 44195, United States
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Independence Ohio, 44131, United States
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Portland Oregon, 97239, United States
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Philadelphia Pennsylvania, 19104, United States
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Sioux Falls South Dakota, 57105, United States
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Charlottesville Virginia, 22908, United States
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Fairfax Virginia, 22031, United States
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Richmond Virginia, 23235, United States
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Richland Washington, 99352, United States
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Spokane Washington, 99204, United States
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Tacoma Washington, 98405, United States
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Milwaukee Wisconsin, 53226, United States
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Box Hill , 3128, Australia
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East Melbourne , 3002, Australia
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Elizabeth Vale , 5112, Australia
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Gosford , 2250, Australia
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Heidelberg , 3084, Australia
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Kogarah , 2217, Australia
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South Brisbane , 4101, Australia
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St Albans , 3021, Australia
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St. Leonards , 2065, Australia
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Westmead , 2145, Australia
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Barretos , 14784, Brazil
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Belo Horizonte , 30380, Brazil
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Florianópolis , 88034, Brazil
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Fortaleza , 60336, Brazil
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Jaú , 17210, Brazil
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Natal , 59075, Brazil
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Porto Alegre , 90610, Brazil
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Porto Alegre , 91350, Brazil
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Recife , 52010, Brazil
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Sao Paulo , 01323, Brazil
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Uberlândia , 38408, Brazil
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Vitoria , 29043, Brazil
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Edmonton Alberta, T6G 1, Canada
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Barrie Ontario, L4M 6, Canada
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Hamilton Ontario, L8V 5, Canada
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Kingston Ontario, K7L 2, Canada
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London Ontario, N6A 5, Canada
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Mississauga Ontario, L5M 2, Canada
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Toronto Ontario, M5G 2, Canada
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Rimouski Quebec, G5L 5, Canada
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Anyang , 45500, China
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Beijing , 10002, China
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Beijing , 10119, China
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Beijing , , China
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Changchun , 13002, China
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Changsha , 41000, China
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Changsha , 41001, China
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Chongqing , 40001, China
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Guangzhou , 51006, China
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Guangzhou , 51006, China
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Guangzhou , 51070, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Hefei , 13350, China
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Hefei , 23003, China
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Jieyang , 52200, China
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Kunming , 65011, China
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Linhai , 31700, China
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Nanchang , 33000, China
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Nanning , 53002, China
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Nantong , 22636, China
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Neijiang , 64100, China
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Ningbo , 31510, China
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Shanghai , 20043, China
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Shaoguan , 51202, China
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Shenyang , 11004, China
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Tianjin , 30006, China
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Wuhan , 43002, China
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Wuhan , 43007, China
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Wuhan , 43007, China
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Zhanjiang , 52400, China
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Zhengzhou City , 45000, China
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Zhengzhou , 45000, China
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Zhongshan , 52840, China
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Zhuhai , 51900, China
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Barranquilla , 08001, Colombia
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Barranquilla , 08002, Colombia
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Bogota D.C. , 11013, Colombia
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Bogotá , , Colombia
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Medellin , 05003, Colombia
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Valledupar , 20000, Colombia
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Avignon Cedex 9 , 84918, France
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Besançon Cedex , 25030, France
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Bordeaux , 33075, France
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Clermont-Ferrand , 63000, France
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Creteil Cedex , 94010, France
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Lorient cedex , 56322, France
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Marseille Cedex 20 , 13015, France
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Montpellier , 34298, France
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Paris Cedex 5 , 75005, France
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Rennes Cedex 9 , 35033, France
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Rouen , 76031, France
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Toulouse CEDEX 09 , 31059, France
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Villejuif Cedex , 94805, France
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Erfurt , 99089, Germany
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Erlangen , 91054, Germany
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Essen , 45147, Germany
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Esslingen , 73730, Germany
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Georgsmarienhuette , 49124, Germany
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Guetersloh , 33332, Germany
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Hannover , 30459, Germany
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Oldenburg , 26121, Germany
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Würzburg , 97080, Germany
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Brescia , 25123, Italy
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Firenze , 50134, Italy
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Lucca , 55100, Italy
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Meldola , 47014, Italy
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Orbassano , 10043, Italy
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Parma , 43126, Italy
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Pavia , 27100, Italy
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Roma , 00128, Italy
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Himeji-shi , 670-8, Japan
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Hiroshima-shi , 730-0, Japan
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Kashiwa , 227-8, Japan
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Kurume-shi , 830-0, Japan
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Natori-shi , 981-1, Japan
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Niigata-shi , 951-8, Japan
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Osaka-shi , 541-8, Japan
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Sendai-shi , 980-0, Japan
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Tokushima-shi , 770-8, Japan
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Toon-shi , 791-0, Japan
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Wakayama-shi , 641-8, Japan
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Changwon-si , 51353, Korea, Republic of
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Cheongju-si , 28644, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Suwon-si , 16499, Korea, Republic of
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Suwon , 16247, Korea, Republic of
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Arequipa , 04000, Peru
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Concepción , 12125, Peru
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Lima , 15036, Peru
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Lima , 15038, Peru
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Lima , LIMA , Peru
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Lima , LIMA , Peru
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Lima , Lima , Peru
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Lima , Lima , Peru
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Trujillo , , Peru
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Brzozów , 36-20, Poland
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Bydgoszcz , 85-79, Poland
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Gdańsk , 80-95, Poland
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Koszalin , 75-58, Poland
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Poznań , 60-56, Poland
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Siedlce , 08-11, Poland
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Tomaszów Mazowiecki , 97-20, Poland
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Warszawa , 02-78, Poland
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Alcabideche , 2755-, Portugal
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Coimbra , 3000-, Portugal
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Lisboa , 1099-, Portugal
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Lisboa , 1400-, Portugal
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Lisboa , 1769-, Portugal
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Lisboa , 1998-, Portugal
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Loures , 2674-, Portugal
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Porto , 4200-, Portugal
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Novosibirsk , 63009, Russian Federation
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Yekaterinburg , 62003, Russian Federation
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Barcelona , 8003, Spain
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Barcelona , 8035, Spain
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Granada , 18016, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Santiago de Compostela , 15706, Spain
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Valencia , 46010, Spain
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Hsinchu , 300, Taiwan
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Taichung , 402, Taiwan
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Taichung , 40705, Taiwan
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Taipei 112 , , Taiwan
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Taipei , 11490, Taiwan
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Taipei , 23561, Taiwan
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Taoyuan City , 333, Taiwan
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Bangkok , 10300, Thailand
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Bangkok , 10700, Thailand
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Hat Yai , 90110, Thailand
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Khon Kaen , 40000, Thailand
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Khon Kaen , 40002, Thailand
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Lampang , 52000, Thailand
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Muang , 22000, Thailand
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Muang , 50200, Thailand
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Mueang , 20000, Thailand
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Naimuang , 30000, Thailand
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Ankara , 06010, Turkey
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Ankara , 06230, Turkey
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Ankara , 06800, Turkey
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Diyarbakir , 21280, Turkey
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Goztepe Istanbul , , Turkey
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Karsiyaka , 35575, Turkey
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Chernihiv , 14029, Ukraine
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Kharkiv Region , 61018, Ukraine
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Kropyvnytskyi , 25011, Ukraine
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Kyiv , 03680, Ukraine
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Uzhgorod , 88000, Ukraine
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Zaporizhzhia , 69000, Ukraine
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Belfast , BT9 7, United Kingdom
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Bristol , BS2 8, United Kingdom
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Dundee , DD1 9, United Kingdom
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Edinburgh , EH4 2, United Kingdom
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Hampshire , SO16 , United Kingdom
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London , NW1 2, United Kingdom
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London , W6 8R, United Kingdom
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Middlesborough , TS4 3, United Kingdom
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Poole , BH15 , United Kingdom
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Rhyl , LL18 , United Kingdom
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Torquay , TQ2 7, United Kingdom
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Truro , TR1 3, United Kingdom
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Wolverhampton , WV10 , United Kingdom
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Hanoi , 10000, Vietnam
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Ho Chi Minh city , 70000, Vietnam
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Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

999

Study ID:

NCT05221840

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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