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 (LATIFY)

  • STATUS
    Recruiting
  • End date
    Jun 4, 2025
  • participants needed
    580
  • sponsor
    AstraZeneca
Updated on 27 October 2022

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.

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.

Details
Condition Advanced or Metastatic Non-Small Cell Lung Cancer
Treatment docetaxel, durvalumab, Ceralasertib
Clinical Study IdentifierNCT05450692
SponsorAstraZeneca
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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