New combo aims to outperform chemo in tough lung cancers

NCT ID NCT05450692

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study tests whether a new drug combination (ceralasertib plus durvalumab) works better than standard chemotherapy (docetaxel) for people with advanced non-small cell lung cancer that has stopped responding to prior treatments. About 594 participants will be randomly assigned to one of the two treatments. The main goal is to see if the combination helps people live longer.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

594 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic non-small cell lung cancer

Contacts and locations

Locations

Research Site

Mobile, Alabama, 36607, United States
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Chandler, Arizona, 85224, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90017, United States
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Whittier, California, 90603, United States
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Jacksonville, Florida, 32256, United States
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Orlando, Florida, 32804, United States
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Athens, Georgia, 30607, United States
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Atlanta, Georgia, 30318, United States
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Fort Wayne, Indiana, 46804, United States
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Baltimore, Maryland, 21231, United States
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Bethesda, Maryland, 20817, United States
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Rockville, Maryland, 20852, United States
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Hattiesburg, Mississippi, 39401, United States
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St Louis, Missouri, 63110, United States
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Omaha, Nebraska, 68114, United States
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Reno, Nevada, 89511, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Canton, Ohio, 44718, United States
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Cleveland, Ohio, 44106, United States
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Allentown, Pennsylvania, 18103, United States
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York, Pennsylvania, 17403, United States
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Houston, Texas, 77090, United States
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Huntsville, Texas, 77340, United States
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Kingwood, Texas, 77339, United States
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Appleton, Wisconsin, 54911, United States
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Buenos Aires, 1058, Argentina
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Pergamino, B2700CPM, Argentina
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Rosario, S2000DSV, Argentina
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Rosario, S2000KZE, Argentina
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San Juan, 5400, Argentina
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Elizabeth Vale, 5112, Australia
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Lismore, 2480, Australia
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Murdoch, 6150, Australia
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South Brisbane, 4101, Australia
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Wollongong, 2500, Australia
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Charleroi, 6000, Belgium
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Ghent, 9000, Belgium
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Libramont-Chevigny, 6800, Belgium
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Roeselare, 8800, Belgium
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Fortaleza, 60810-180, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 90610-000, Brazil
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Salvador, 40170-110, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 09323-900, Brazil
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Vancouver, British Columbia, VSZ 4E6, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Chicoutimi, Quebec, G7H 7P2, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Québec, Quebec, G1V 4G5, Canada
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Rimouski, Quebec, G5L 5T1, Canada
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Baoding, 071000, China
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Beijing, 100021, China
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Beijing, 100044, China
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Changsha, 410008, China
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Chengdu, 610041, China
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Deyang, 618000, China
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Guangzhou, 510080, China
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Hangzhou, 310009, China
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Hefei, 230001, China
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Jinan, 250013, China
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Linyi, 276000, China
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Nanchang, 330000, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Nashik, 422011, China
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Qingdao, 266071, China
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Taiyuan, 030000, China
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Tianjin, 300052, China
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Tianjin, 300060, China
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Wuhan, 430000, China
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Wuhan, 430022, China
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Wuhan, 430079, China
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Zhanjiang, 524001, China
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Zhengzhou, 450008, China
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Angers, 49933, France
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Clamart, 92140, France
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Clermont-Ferrand, 63011, France
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Créteil, 94010, France
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Lyon, 69373, France
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Montpellier, 34070, France
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Nantes, 44093, France
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Paris, 75014, France
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Pessac, 33604, France
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Saint-Herblain, 44805, France
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Saint-Quentin, 02321, France
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Vantoux, 57070, France
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Villefranche-sur-Saône, 69655, France
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Villejuif, 94805, France
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Berlin, 12351, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Karlsruhe, 76137, Germany
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Kempten, 87439, Germany
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Löwenstein, 74245, Germany
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Moers, 47441, Germany
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Hong Kong, 999077, Hong Kong
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King's Park, 150001, Hong Kong
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Tun Mun, Hong Kong
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Budapest, 1121, Hungary
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Székesfehérvár, 8000, Hungary
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Jaipur, 302017, India
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Pune, 411001, India
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Surat, 395002, India
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Cork, T12 DV56, Ireland
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Dublin, D09 V2N0, Ireland
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Dublin, Ireland
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Limerick, V94 F858, Ireland
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Aviano, 33081, Italy
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Livorno, 57124, Italy
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Meldola, 47014, Italy
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Milan, 20133, Italy
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Monza, 20900, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Parma, 43126, Italy
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Roma, 00128, Italy
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Rozzano, 20089, Italy
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Verona, 37126, Italy
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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8677, Japan
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Chūōku, 104-0045, Japan
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Kōtoku, 135-8550, Japan
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Kurashiki-shi, 710-8602, Japan
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Kurume-shi, 830-0011, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 460-0001, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-0873, Japan
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Sunto-gun, 411-8777, Japan
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Toyoake-shi, 470-1192, Japan
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Yokohama, 241-8515, Japan
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Heerlen, 6419 PC, Netherlands
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Tilburg, 5022 GC, Netherlands
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Gdansk, 80-952, Poland
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Krakow, 30-727, Poland
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Krakow, 31-826, Poland
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Poznan, 60-693, Poland
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Skórzewo, 60-185, Poland
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Bucharest, 022328, Romania
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Bucharest, 031422, Romania
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Cluj-Napoca, 400015, Romania
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Cluj-Napoca, 400641, Romania
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Craiova, 200347, Romania
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Craiova, 200385, Romania
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Floreşti, 407280, Romania
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Oradea, 410469, Romania
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Timișoara, 300166, Romania
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Timișoara, 300239, Romania
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Belgrade, 11080, Serbia
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Cheongju-si, 28644, South Korea
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Seoul, 03080, South Korea
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Seoul, 03181, South Korea
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Seoul, 03722, South Korea
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Seoul, 07061, South Korea
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Seoul, 138-736, South Korea
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Suwon, 16247, South Korea
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A Coruña, 15006, Spain
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A Coruña, 15009, Spain
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Barcelona, 08041, Spain
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Barcelona, 8003, Spain
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Barcelona, 8035, Spain
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Castellon, 12002, Spain
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Córdoba, 14004, Spain
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Hospitalet deLlobregat, 08907, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Málaga, 29009, Spain
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Ourense, 32005, Spain
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Palma de Mallorca, 07198, Spain
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Pamplona, 31008, Spain
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Pozuelo de Alarcón, 28223, Spain
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Sabadell, 08208, Spain
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Servilla, 41014, Spain
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Zaragoza, 50009, Spain
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Taichung, 40201, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333423, Taiwan
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Yunlin, 640, Taiwan
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Guildford, United Kingdom
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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
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Sutton, SM2 5PT, United Kingdom

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