Ceralasertib / Advanced Or Metastatic NSCLC / Durvalumab · Phase 2 Trial

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

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registry record documenting a planned study of ceralasertib plus durvalumab in treatment-refractory advanced or metastatic NSCLC. Recruitment is complete with 39 participants enrolled, but no results have been posted to this registry record and the outcome data remain unreported as of the current submission.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Advanced or Metastatic NSCLC; age from 18 Years. Intervention: Group A. n = 39. 8 sites: Russia.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 2 trial registry record with no results posted; enrollment is complete but outcomes have not yet been reported or analysed.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Objective response rate (ORR) (assessed at At month 6 after the last patient's first dose (approximately 18 months).)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationAdvanced or Metastatic NSCLC; age from 18 Years

Sample size39

InterventionGroup A

Setting8 sites: Russia

Reported figures

Quoted from the source exactly as published.

Planned enrollment (actual)39

PhasePhase 2

Primary outcome measureObjective response rate (ORR)

Primary outcome assessment timepointMonth 6 after last patient's first dose (approximately 18 months)

Caveats

No results reported in this registry record; outcomes remain unreported.
No control or comparator arm identified in registry record.
Blinding status not specified.
Follow-up duration and analysis approach not detailed in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design; no control arm specified in registry.

Directness

strong

Addresses clinical efficacy and safety in intended population with hard endpoint.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

insufficient

No blinding, comparator, or analytical approach described in registry record.

Sample adequacy

limited

Actual enrollment 39 participants; modest sample for Phase 2 efficacy claim.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05941897). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 39 participants (ACTUAL). Conditions: Advanced or Metastatic NSCLC. Interventions: DRUG: Ceralasertib; DRUG: Durvalumab. Primary outcome measures: Objective response rate (ORR) , At month 6 after the last patient's first dose (approximately 18 months).. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

CeralasertibAdvanced Or Metastatic NSCLCNCT05941897DurvalumabAstraZeneca