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Trial Title:
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
NCT ID:
NCT05941897
Condition:
Advanced or Metastatic NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Durvalumab
Conditions: Keywords:
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Respiratory Tract Diseases
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Durvalumab
Ceralasertib
ATR inhibitor
Immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ceralasertib
Description:
Participants will receive ceralasertib oral tablets.
Arm group label:
Group A
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Participants will receive durvalumab as an intravenous infusion
Arm group label:
Group A
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.
Detailed description:
This is a single-arm study, all participants will be assigned to one treatment group -
ceralasertib plus durvalumab combination therapy. Each 28-day cycle will begin with
ceralasertib administered orally followed by durvalumab administered intravenously.
The objectives of the current single-arm local study are to estimate the efficacy and
safety of ceralasertib and durvalumab combination in local population to obtain relevant
information for routine clinical practice. The results of this additional study will
provide clinical data on efficacy and safety of an innovation drug in the new region -
Russian Federation.
Criteria for eligibility:
Criteria:
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.
- 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.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO)
performance status of 0 or 1.
- Adequate organ function and marrow reserve.
- Body weight > 30 kg and no cancer-associated cachexia.
Exclusion Criteria:
- Participant with mixed SCLC and NSCLC histology.
- Brain metastases or spinal cord compression unless the participant is stable and off
steroids.
- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- History of leptomeningeal carcinomatosis.
- Participants who have received more than one line of prior anti-PD-(L)1.
- Participants must not have experienced a toxicity that led to discontinuation of the
prior anti-PD(L)1 therapy.
- Participants 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.
- Participants 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.
- Participants who have received more than one prior line of platinum-based
chemotherapy in metastatic setting.
- As judged by the investigator, any evidence of medical condition, which, in the
investigator's opinion, makes it undesirable for the participant to participate in
the study.
- Participants who have received a prior ATR inhibitor.
- Diagnosis of ataxia telangiectasia.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
111123
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
115478
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
115533
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
125284
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
143423
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Nizhny Novgorod
Zip:
603126
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Zip:
197758
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
St. Petersburg
Zip:
197758
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
St. Petersburg
Zip:
198255
Country:
Russian Federation
Start date:
June 21, 2023
Completion date:
July 29, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05941897
