NCT05450692

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 594 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ceralasertib	Participants will receive ceralasertib oral tablets.
DRUG	Durvalumab	Participants will receive durvalumab as an intravenous infusion.
DRUG	Docetaxel	Participants will received docetaxel as an intravenous infusion.

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-10-06
• Completion: 2027-12-31
• First posted: 2022-07-11
• Last updated: 2026-04-16

Locations

191 sites across 23 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Netherlands, Poland, Romania, Serbia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study