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

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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCeralasertib and Durvalumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?191 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: AstraZeneca
Interventions being studied: Drug: Ceralasertib; Drug: Durvalumab; Drug: Docetaxel

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
Documented radiological PD whilst on or after receiving the most recent treatment regimen.
Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
Adequate organ function and marrow reserve
Minimum life expectancy of 12 weeks.
Body weight \> 30 kg and no cancer-associated cachexia.
Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

Reasons someone may not be able to joinExclusion criteria

Participant with mixed SCLC and NSCLC histology.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
Persistent toxicities (CTCAE Grade \> 2) caused by previous anticancer therapy.
Active or prior documented autoimmune or inflammatory disorders.
Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
Participants: 1. Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy. 2. All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved. 3. Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy. 4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \> 10 mg prednisone or equivalent per day.
Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteMobile, Alabama
Research SiteChandler, Arizona
Research SiteLos Alamitos, California
Research SiteLos Angeles, California
Research SiteWhittier, California
Research SiteJacksonville, Florida
Research SiteOrlando, Florida
Research SiteAthens, Georgia
Research SiteAtlanta, Georgia
Research SiteFort Wayne, Indiana
Research SiteBaltimore, Maryland
Research SiteBethesda, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2026. Always confirm current availability with the study team.

View original record ↗