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)
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|ClinicalTrials.gov Identifier: NCT05450692|
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : March 15, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Non-Small Cell Lung Cancer||Drug: Ceralasertib Drug: Durvalumab Drug: Docetaxel||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||580 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||September 15, 2022|
|Estimated Primary Completion Date :||May 22, 2025|
|Estimated Study Completion Date :||May 22, 2025|
Experimental: Group A: Ceralasertib plus durvalumab combination therapy
Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
Participants will receive ceralasertib oral tablets.
Participants will receive durvalumab as an intravenous infusion.
Active Comparator: Group B: Docetaxel monotherapy
Participants will be administered docetaxel (standard of care) administered intravenously.
Participants will received docetaxel as an intravenous infusion.
- Overall Survival (OS) [ Time Frame: Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years) ]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.
- Progression-Free Survival (PFS) [ Time Frame: Up to 3 years ]PFS will be defined as the time from the date of randomisation until the date of objective PD.
- Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]ORR is defined as the proportion of participant who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1.
- Duration of Response (DoR) [ Time Frame: Up to 3 years ]DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.
- Time To Response (TTR) [ Time Frame: Up to 3 years ]TTR is defined as the time from randomisation until the date of first documented objective response.
- Disease Control Rate (DCR) [ Time Frame: At Week 18 ]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.
- Time to second progression or death (PFS2) [ Time Frame: Up to 3 years ]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.
- Overall Survival (OS) at 12 months [ Time Frame: At 12 months ]OS is defined as time from randomisation until the data of death due to any cause.
- Time To Deterioration (TTD) of health-related quality of life (QoL) [ Time Frame: Up to 3 years ]TTD is defined as the time from randomisation until the date of first confirmed deterioration.
- TTD of physical function [ Time Frame: Up to 3 years ]TTD in physical functioning is measured by the EORTC QLQ-C30 Physical Function subscale of the EORTC QLQ-C30.
- Plasma concentrations for ceralasertib plus durvalumab combination therapy [ Time Frame: Up to 3 years ]The PK plasma concentration of ceralasertib when administered in combination with durvalumab will be assessed.
- Number of participants with Adverse Evens (AEs) [ Time Frame: Up to 3 years ]The safety and tolerability of ceralasertib plus durvalumab combination therapy as compared with docetaxel will be assessed.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05450692
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|
|Other Study ID Numbers:||
2022-000493-26 ( EudraCT Number )
|First Posted:||July 11, 2022 Key Record Dates|
|Last Update Posted:||March 15, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
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:
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Statistical Analysis Plan (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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological