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
NCT ID: NCT05450692
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
594 participants
INTERVENTIONAL
2022-09-15
2026-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Ceralasertib plus durvalumab combination therapy
Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
Ceralasertib
Participants will receive ceralasertib oral tablets.
Durvalumab
Participants will receive durvalumab as an intravenous infusion.
Group B: Docetaxel monotherapy
Participants will be administered docetaxel (standard of care) administered intravenously.
Docetaxel
Participants will received docetaxel as an intravenous infusion.
Interventions
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Ceralasertib
Participants will receive ceralasertib oral tablets.
Durvalumab
Participants will receive durvalumab as an intravenous infusion.
Docetaxel
Participants will received docetaxel as an intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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:
1. Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
2. All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
3. 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.
4. 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.
18 Years
130 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Mobile, Alabama, United States
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Chandler, Arizona, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Whittier, California, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Fort Wayne, Indiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Rockville, Maryland, United States
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Hattiesburg, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Reno, Nevada, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cleveland, Ohio, United States
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Allentown, Pennsylvania, United States
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York, Pennsylvania, United States
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Houston, Texas, United States
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Huntsville, Texas, United States
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Kingwood, Texas, United States
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Appleton, Wisconsin, United States
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Buenos Aires, , Argentina
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Pergamino, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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Elizabeth Vale, , Australia
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Lismore, , Australia
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Murdoch, , Australia
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South Brisbane, , Australia
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Wollongong, , Australia
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Charleroi, , Belgium
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Ghent, , Belgium
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Libramont-Chevigny, , Belgium
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Roeselare, , Belgium
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Fortaleza, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Vancouver, British Columbia, Canada
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Newmarket, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Baoding, , China
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Beijing, , China
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Beijing, , China
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Changsha, , China
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Chengdu, , China
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Deyang, , China
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Guangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Jinan, , China
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Linyi, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Nashik, , China
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Qingdao, , China
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Taiyuan, , China
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Tianjin, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Wuhan, , China
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Zhanjiang, , China
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Zhengzhou, , China
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Angers, , France
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Clamart, , France
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Clermont-Ferrand, , France
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Créteil, , France
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Lyon, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Pessac, , France
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Saint-Herblain, , France
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Saint-Quentin, , France
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Vantoux, , France
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Villefranche-sur-Saône, , France
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Villejuif, , France
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Berlin, , Germany
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Freiburg im Breisgau, , Germany
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Gauting, , Germany
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Karlsruhe, , Germany
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Kempten, , Germany
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Löwenstein, , Germany
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Moers, , Germany
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Hong Kong, , Hong Kong
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King's Park, , Hong Kong
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Tun Mun, , Hong Kong
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Budapest, , Hungary
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Székesfehérvár, , Hungary
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Jaipur, , India
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Pune, , India
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Surat, , India
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Cork, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Limerick, , Ireland
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Aviano, , Italy
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Livorno, , Italy
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Meldola, , Italy
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Milan, , Italy
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Monza, , Italy
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Napoli, , Italy
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Padua, , Italy
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Parma, , Italy
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Perugia, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Verona, , Italy
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Bunkyō City, , Japan
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Bunkyō City, , Japan
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Chūōku, , Japan
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Kōtoku, , Japan
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Kurashiki-shi, , Japan
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Kurume-shi, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Sunto-gun, , Japan
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Toyoake-shi, , Japan
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Yokohama, , Japan
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Heerlen, , Netherlands
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Tilburg, , Netherlands
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Gdansk, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Skórzewo, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Craiova, , Romania
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Floreşti, , Romania
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Oradea, , Romania
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Timișoara, , Romania
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Timișoara, , Romania
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Belgrade, , Serbia
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Cheongju-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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A Coruña, , Spain
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Castellon, , Spain
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Córdoba, , Spain
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Hospitalet deLlobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Ourense, , Spain
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Palma de Mallorca, , Spain
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Pamplona, , Spain
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Pozuelo de Alarcón, , Spain
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Sabadell, , Spain
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Servilla, , Spain
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Zaragoza, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Yunlin, , Taiwan
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Guildford, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
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Stevenage, , United Kingdom
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Sutton, , United Kingdom
Countries
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Related Links
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Lung Cancer Study Locator details (for US)
Other Identifiers
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2022-000493-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D533BC00001
Identifier Type: -
Identifier Source: org_study_id
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