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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced or Metastatic Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Ceralasertib; Drug: Durvalumab; Drug: Docetaxel

Detailed Description

This study will consist of two treatment arms (Groups A and B).

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.

• Study Type: Interventional
• Enrollment (Actual): 594
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1058
    • Research Site
  • Pergamino, Argentina, B2700CPM
    • Research Site
  • Rosario, Argentina, S2000KZE
    • Research Site
  • Rosario, Argentina, S2000DSV
    • Research Site
  • San Juan, Argentina, 5400
    • Research Site
• Australia
  • Elizabeth Vale, Australia, 5112
    • Research Site
  • Lismore, Australia, 2480
    • Research Site
  • Murdoch, Australia, 6150
    • Research Site
  • South Brisbane, Australia, 4101
    • Research Site
  • Wollongong, Australia, 2500
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• Belgium
  • Ghent, Belgium, 9000
    • Research Site
  • Roeselare, Belgium, 8800
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• Brazil
  • Fortaleza, Brazil, 60810-180
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Porto Alegre, Brazil, 90110-270
    • Research Site
  • Salvador, Brazil, 40170-110
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Research Site
  • São Paulo, Brazil, 09323-900
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• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, VSZ 4E6
      • Research Site
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Research Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7P2
      • Research Site
    • Montreal, Quebec, Canada, H2L 4M1
      • Research Site
    • Montreal, Quebec, Canada, H3G 1A4
      • Research Site
    • Québec, Quebec, Canada, G1V 4G5
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    • Rimouski, Quebec, Canada, G5L 5T1
      • Research Site
• China
  • Baoding, China, 071000
    • Research Site
  • Beijing, China, 100021
    • Research Site
  • Beijing, China, 100044
    • Research Site
  • Changsha, China, 410008
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Deyang, China, 618000
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Hefei, China, 230001
    • Research Site
  • Jinan, China, 250013
    • Research Site
  • Linyi, China, 276000
    • Research Site
  • Nanchang, China, 330000
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Nanning, China, 530021
    • Research Site
  • Nashik, China, 422011
    • Research Site
  • Qingdao, China, 266071
    • Research Site
  • Taiyuan, China, 030000
    • Research Site
  • Tianjin, China, 300060
    • Research Site
  • Tianjin, China, 300052
    • Research Site
  • Wuhan, China, 430079
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430000
    • Research Site
  • Zhanjiang, China, 524001
    • Research Site
  • Zhengzhou, China, 450008
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• France
  • Angers, France, 49933
    • Research Site
  • Clamart, France, 92140
    • Research Site
  • Clermont-Ferrand, France, 63011
    • Research Site
  • Créteil, France, 94010
    • Research Site
  • Lyon, France, 69373
    • Research Site
  • Montpellier, France, 34070
    • Research Site
  • Nantes, France, 44093
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  • Paris, France, 75014
    • Research Site
  • Pessac, France, 33604
    • Research Site
  • Saint-Herblain, France, 44805
    • Research Site
  • Saint-Quentin, France, 02321
    • Research Site
  • Vantoux, France, 57070
    • Research Site
  • Villefranche-sur-Saône, France, 69655
    • Research Site
  • Villejuif, France, 94805
    • Research Site
• Germany
  • Berlin, Germany, 12351
    • Research Site
  • Freiburg im Breisgau, Germany, 79106
    • Research Site
  • Gauting, Germany, 82131
    • Research Site
  • Karlsruhe, Germany, 76137
    • Research Site
  • Kempten, Germany, 87439
    • Research Site
  • Löwenstein, Germany, 74245
    • Research Site
  • Moers, Germany, 47441
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Research Site
  • King's Park, Hong Kong, 150001
    • Research Site
  • Tun Mun, Hong Kong
    • Research Site
• Hungary
  • Budapest, Hungary, 1121
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
• India
  • Jaipur, India, 302017
    • Research Site
  • Pune, India, 411001
    • Research Site
  • Surat, India, 395002
    • Research Site
• Ireland
  • Cork, Ireland, T12 DV56
    • Research Site
  • Dublin, Ireland
    • Research Site
  • Dublin, Ireland, D09 V2N0
    • Research Site
  • Limerick, Ireland, V94 F858
    • Research Site
• Italy
  • Aviano, Italy, 33081
    • Research Site
  • Livorno, Italy, 57124
    • Research Site
  • Meldola, Italy, 47014
    • Research Site
  • Milan, Italy, 20133
    • Research Site
  • Monza, Italy, 20900
    • Research Site
  • Naples, Italy, 80131
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Parma, Italy, 43126
    • Research Site
  • Perugia, Italy, 06129
    • Research Site
  • Roma, Italy, 00128
    • Research Site
  • Rozzano, Italy, 20089
    • Research Site
  • Verona, Italy, 37126
    • Research Site
• Japan
  • Bunkyō City, Japan, 113-8431
    • Research Site
  • Bunkyō City, Japan, 113-8677
    • Research Site
  • Chūōku, Japan, 104-0045
    • Research Site
  • Kurashiki-shi, Japan, 710-8602
    • Research Site
  • Kurume-shi, Japan, 830-0011
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Research Site
  • Matsuyama, Japan, 791-0280
    • Research Site
  • Nagoya, Japan, 460-0001
    • Research Site
  • Niigata, Japan, 951-8566
    • Research Site
  • Osaka, Japan, 541-8567
    • Research Site
  • Sakaishi, Japan, 591-8555
    • Research Site
  • Sapporo, Japan, 003-0804
    • Research Site
  • Sendai, Japan, 980-0873
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Research Site
  • Toyoake-shi, Japan, 470-1192
    • Research Site
  • Yokohama, Japan, 241-8515
    • Research Site
• Netherlands
  • Heerlen, Netherlands, 6419 PC
    • Research Site
  • Tilburg, Netherlands, 5022 GC
    • Research Site
• Poland
  • Gdansk, Poland, 80-952
    • Research Site
  • Krakow, Poland, 30-727
    • Research Site
  • Krakow, Poland, 31-826
    • Research Site
  • Poznan, Poland, 60-693
    • Research Site
  • Skórzewo, Poland, 60-185
    • Research Site
• Romania
  • Bucharest, Romania, 022328
    • Research Site
  • Bucharest, Romania, 031422
    • Research Site
  • Cluj-Napoca, Romania, 400015
    • Research Site
  • Cluj-Napoca, Romania, 400641
    • Research Site
  • Craiova, Romania, 200347
    • Research Site
  • Craiova, Romania, 200385
    • Research Site
  • Floreşti, Romania, 407280
    • Research Site
  • Oradea, Romania, 410469
    • Research Site
  • Timișoara, Romania, 300166
    • Research Site
  • Timișoara, Romania, 300239
    • Research Site
• Serbia
  • Belgrade, Serbia, 11080
    • Research Site
• South Korea
  • Cheongju-si, South Korea, 28644
    • Research Site
  • Seoul, South Korea, 03080
    • Research Site
  • Seoul, South Korea, 03722
    • Research Site
  • Seoul, South Korea, 138-736
    • Research Site
  • Seoul, South Korea, 03181
    • Research Site
  • Seoul, South Korea, 07061
    • Research Site
  • Suwon, South Korea, 16247
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Research Site
  • A Coruña, Spain, 15009
    • Research Site
  • Barcelona, Spain, 8035
    • Research Site
  • Barcelona, Spain, 08041
    • Research Site
  • Barcelona, Spain, 8003
    • Research Site
  • Castellon, Spain, 12002
    • Research Site
  • Córdoba, Spain, 14004
    • Research Site
  • Hospitalet deLlobregat, Spain, 08907
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Málaga, Spain, 29009
    • Research Site
  • Ourense, Spain, 32005
    • Research Site
  • Palma de Mallorca, Spain, 07198
    • Research Site
  • Pamplona, Spain, 31008
    • Research Site
  • Pozuelo de Alarcón, Spain, 28223
    • Research Site
  • Sabadell, Spain, 08208
    • Research Site
  • Servilla, Spain, 41014
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
• Taiwan
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40201
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taoyuan District, Taiwan, 333423
    • Research Site
  • Yunlin, Taiwan, 640
    • Research Site
• United Kingdom
  • Guildford, United Kingdom
    • Research Site
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • Research Site
  • Stevenage, United Kingdom, SG1 4AB
    • Research Site
  • Sutton, United Kingdom, SM2 5PT
    • Research Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Research Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
  • California
    • Los Alamitos, California, United States, 90720
      • Research Site
    • Los Angeles, California, United States, 90017
      • Research Site
    • Whittier, California, United States, 90603
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Research Site
    • Orlando, Florida, United States, 32804
      • Research Site
    • Tampa, Florida, United States, 33612
      • Research Site
  • Georgia
    • Athens, Georgia, United States, 30607
      • Research Site
    • Atlanta, Georgia, United States, 30318
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Research Site
    • Bethesda, Maryland, United States, 20817
      • Research Site
    • Rockville, Maryland, United States, 20852
      • Research Site
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Research Site
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Research Site
  • Nevada
    • Reno, Nevada, United States, 89511
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Research Site
    • Cleveland, Ohio, United States, 44106
      • Research Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Research Site
    • York, Pennsylvania, United States, 17403
      • Research Site
  • Texas
    • Houston, Texas, United States, 77090
      • Research Site
    • Huntsville, Texas, United States, 77340
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Research Site
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Ceralasertib plus durvalumab combination therapy; Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.	Drug: Ceralasertib; Participants will receive ceralasertib oral tablets.; Drug: Durvalumab; Participants will receive durvalumab as an intravenous infusion.
Active Comparator: Group B: Docetaxel monotherapy; Participants will be administered docetaxel (standard of care) administered intravenously.	Drug: Docetaxel; Participants will received docetaxel as an intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS will be defined as the time from the date of randomisation until the date of objective PD.	Up to 3 years
Objective Response Rate (ORR)	ORR is defined as the proportion of participant who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1.	Up to 3 years
Duration of Response (DoR)	DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.	Up to 3 years
Time To Response (TTR)	TTR is defined as the time from randomisation until the date of first documented objective response.	Up to 3 years
Disease Control Rate (DCR)	DCR at 18 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) for at least 17 weeks.	At Week 18
Time to second progression or death (PFS2)	Time from randomisation to PFS2 will be defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.	Up to 3 years
Overall Survival (OS) at 12 months	OS is defined as time from randomisation until the data of death due to any cause.	At 12 months
Time To Deterioration (TTD) of health-related quality of life (QoL)	TTD is defined as the time from randomisation until the date of first confirmed deterioration.	Up to 3 years
TTD of physical function	TTD in physical functioning is measured by the EORTC QLQ-C30 Physical Function subscale of the EORTC QLQ-C30.	Up to 3 years
Plasma concentrations for ceralasertib plus durvalumab combination therapy	The PK plasma concentration of ceralasertib when administered in combination with durvalumab will be assessed.	Up to 3 years
Number of participants with Adverse Evens (AEs)	The safety and tolerability of ceralasertib plus durvalumab combination therapy as compared with docetaxel will be assessed.	Up to 3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Publications and helpful links

Helpful Links

• Lung Cancer Study Locator details (for US)

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): October 6, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Docetaxel; Lung cancer; Durvalumab; Ceralasertib
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; ceralasertib; durvalumab
• Other Study ID Numbers: D533BC00001; 2022-000493-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No