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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509429-37-00
Acronym
D533BC00001
Enrollment
520
Registered
2024-01-31
Start date
2022-10-03
Completion date
Unknown
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Non-Small Cell Lung Cancer

Brief summary

OS is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.

Detailed description

To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, DoR, TTR, DCR at 18 weeks, PFS2, OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability., To assess the PK of ceralasertib when administered in combination with durvalumab., To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel

Interventions

DRUG250 mg
DRUGDOCETAXEL
DRUGMYCOPHENOLATE MOFETIL
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGINFLIXIMAB
DRUGCeralasertib

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OS is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.

Secondary

MeasureTime frame
To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, DoR, TTR, DCR at 18 weeks, PFS2, OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability., To assess the PK of ceralasertib when administered in combination with durvalumab., To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel

Countries

Belgium, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026