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Clinical Trials in the USA / NCT05450692
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-09-15
Last updated
2026-07-13

Condition(s) studied

Advanced or Metastatic Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

CeralasertibDurvalumabDocetaxel

Ceralasertib: Participants will receive ceralasertib oral tablets.

Durvalumab: Participants will receive durvalumab as an intravenous infusion.

Docetaxel: Participants will received docetaxel as an intravenous infusion.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion 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). Exclusion 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.

Primary outcome measure(s)

Trial sites (191)

FacilityCityRegionStatus
Research Site Mobile Alabama
Research Site Chandler Arizona
Research Site Los Alamitos California
Research Site Los Angeles California
Research Site Whittier California
Research Site Jacksonville Florida
Research Site Orlando Florida
Research Site Athens Georgia
Research Site Atlanta Georgia
Research Site Fort Wayne Indiana
Research Site Baltimore Maryland
Research Site Bethesda Maryland
Research Site Rockville Maryland
Research Site Hattiesburg Mississippi
Research Site St Louis Missouri
Research Site Omaha Nebraska
Research Site Reno Nevada
Research Site Charlotte North Carolina
Research Site Winston-Salem North Carolina
Research Site Canton Ohio
Research Site Cleveland Ohio
Research Site Allentown Pennsylvania
Research Site York Pennsylvania
Research Site Houston Texas
Research Site Huntsville Texas
Research Site Kingwood Texas
Research Site Appleton Wisconsin
Research Site Buenos Aires Argentina
Research Site Pergamino Argentina
Research Site Rosario Argentina
Research Site Rosario Argentina
Research Site San Juan Argentina
Research Site Elizabeth Vale Australia
Research Site Lismore Australia
Research Site Murdoch Australia
Research Site South Brisbane Australia
Research Site Wollongong Australia
Research Site Charleroi Belgium
Research Site Ghent Belgium
Research Site Libramont-Chevigny Belgium

+ 151 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05450692 on ClinicalTrials.gov ↗ ← All trials in the USA