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
LATIFY
A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY
2 other identifiers
interventional
594
23 countries
191
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2022
Longer than P75 for phase_3
191 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedStudy Start
First participant enrolled
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedApril 16, 2026
April 1, 2026
3.1 years
July 6, 2022
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
The superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel will be demonstrated by assessment of OS (HR with 95% CI and p-value) in participants with advanced NSCLC after second- or third-line therapy and without actionable genomic alterations. OS is defined as time from randomisation until the date of death due to any cause.
Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)
Secondary Outcomes (11)
Progression-Free Survival (PFS)
Up to 3 years
Objective Response Rate (ORR)
Up to 3 years
Duration of Response (DoR)
Up to 3 years
Time To Response (TTR)
Up to 3 years
Disease Control Rate (DCR)
At Week 18
- +6 more secondary outcomes
Study Arms (2)
Group A: Ceralasertib plus durvalumab combination therapy
EXPERIMENTALParticipants will be administered ceralasertib orally followed by durvalumab administered intravenously.
Group B: Docetaxel monotherapy
ACTIVE COMPARATORParticipants will be administered docetaxel (standard of care) administered intravenously.
Interventions
Participants will receive ceralasertib oral tablets.
Participants will receive durvalumab as an intravenous infusion.
Participants will received docetaxel as an intravenous infusion.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (191)
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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Tampa, Florida, 33612, 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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Ghent, 9000, 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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Perugia, 06129, 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 District, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2022
First Posted
July 11, 2022
Study Start
September 15, 2022
Primary Completion
October 6, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.