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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05450692




Registration number
NCT05450692
Ethics application status
Date submitted
6/07/2022
Date registered
11/07/2022

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2022-000493-26
Secondary ID [2] 0 0
D533BC00001
Universal Trial Number (UTN)
Trial acronym
LATIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ceralasertib
Treatment: Drugs - Durvalumab
Treatment: Drugs - Docetaxel

Experimental: Group A: Ceralasertib plus durvalumab combination therapy - Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.

Active comparator: Group B: Docetaxel monotherapy - Participants will be administered docetaxel (standard of care) administered intravenously.


Treatment: Drugs: Ceralasertib
Participants will receive ceralasertib oral tablets.

Treatment: Drugs: Durvalumab
Participants will receive durvalumab as an intravenous infusion.

Treatment: Drugs: Docetaxel
Participants will received docetaxel as an intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Time To Response (TTR)
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Disease Control Rate (DCR)
Timepoint [5] 0 0
At Week 18
Secondary outcome [6] 0 0
Time to second progression or death (PFS2)
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Overall Survival (OS) at 12 months
Timepoint [7] 0 0
At 12 months
Secondary outcome [8] 0 0
Time To Deterioration (TTD) of health-related quality of life (QoL)
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
TTD of physical function
Timepoint [9] 0 0
Up to 3 years
Secondary outcome [10] 0 0
Plasma concentrations for ceralasertib plus durvalumab combination therapy
Timepoint [10] 0 0
Up to 3 years
Secondary outcome [11] 0 0
Number of participants with Adverse Evens (AEs)
Timepoint [11] 0 0
Up to 3 years

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/08/2025
Actual
Sample size
Target
Accrual to date
Final
594
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [2] 0 0
Research Site - Lismore
Recruitment hospital [3] 0 0
Research Site - Murdoch
Recruitment hospital [4] 0 0
Research Site - South Brisbane
Recruitment hospital [5] 0 0
Research Site - Wendouree
Recruitment hospital [6] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3355 - Wendouree
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment outside Australia
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United States of America
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Servilla
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Yunlin
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Bristol
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Guildford
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Stevenage
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Sutton
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05450692