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Active (not recruiting) Phase 3 NCT05450692

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

Phase 3 – large-scale trial before approval
Conditions: Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Description
This study will consist of two treatment arms (Groups A and B). Participants will be randomised in a 1:1 ratio to one of the two treatment groups: * Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously. * Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.
Who can participate
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.
Locations 23
Argentina (1)
Research Site
Buenos Aires
Australia (1)
Research Site
Elizabeth Vale
Belgium (1)
Research Site
Ghent
Brazil (1)
Research Site
Fortaleza
Canada (1)
Research Site
Vancouver , British Columbia
China (1)
Research Site
Baoding
France (1)
Research Site
Angers
Germany (1)
Research Site
Berlin
Hong Kong (1)
Research Site
Hong Kong
Hungary (1)
Research Site
Budapest
India (1)
Research Site
Jaipur
Ireland (1)
Research Site
Cork
Italy (1)
Research Site
Aviano
Japan (1)
Research Site
Bunkyō City
Netherlands (1)
Research Site
Heerlen
Poland (1)
Research Site
Gdansk
Romania (1)
Research Site
Bucharest
Serbia (1)
Research Site
Belgrade
South Korea (1)
Research Site
Cheongju-si
Spain (1)
Research Site
A Coruña
Taiwan (1)
Research Site
Taichung
United Kingdom (1)
Research Site
Guildford
United States (1)
Research Site
Mobile , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
15.09.2022
Completion date
31.12.2027
Registry ID
NCT05450692
Source
anzctr
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