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
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
-
Participants will receive durvalumab as an intravenous infusion.
- DRUG
-
Participants will received docetaxel as an intravenous infusion.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - 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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