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

NCT05450692 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY
  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2025-10-06
Completion
2027-12-31
FDA Drug
Yes

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

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450692 on ClinicalTrials.gov