A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy
- Sponsor
- AstraZeneca
- Study ID
- NCT05941897
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Advanced or Metastatic NSCLC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ceralasertib — DRUGParticipants will receive ceralasertib oral tablets.
- Durvalumab — DRUGParticipants will receive durvalumab as an intravenous infusion
Study Details
A study to investigate efficacy and safety of ceralasertib plus durvalumab in participants aged ≥ 18 years with advanced or metastatic non-small cell lung cancer whose disease progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
Key Dates
- Start date
- Jun 21, 2023
- Status verified
- Mar 2026
- Primary completion
- Jul 29, 2024
- Completion
- Jan 1, 2027
Study Design
- Enrollment
- 39 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Group ACeralasertib plus durvalumab combination therapy Participants will be administered orally ceralasertib followed by IV durvalumab each 28 days cycle.
Primary Outcome Measure
Objective response rate (ORR) [ Time Frame: At month 6 after the last patient's first dose (approximately 18 months). ]