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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Participants will receive ceralasertib oral tablets.
Participants will receive durvalumab as an intravenous infusion
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Saint Petersburg, Russia
Research Site
Saint Petersburg, Russia
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who have a complete response (CR) or partial response (PR) per RECIST 1.1.
Time frame: At month 6 after the last patient's first dose (approximately 18 months).
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.
Time frame: Up to 30 months
Time to response (TTR)
Time to response (TTR) is defined as the time from the start of treatment until the date of first documented objective response per RECIST 1.1.
Time frame: Up to 30 months
Disease control rate (DCR)
DCR at 18 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) for at least 17 weeks per RECIST 1.1.
Time frame: At month 6 after the last patient's first dose (approximately 18 months).
Progression free survival (PFS)
PFS is defined as time from the start of treatment until progression per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1).
Time frame: Up to 30 months
Overall survival (OS)
OS is defined as time from the start of treatment until the date of death due to any cause.
Time frame: Up to 30 months
Number and percentage of AEs in patients receiving Ceralasertib and Durvalumab combination
The safety and tolerability profile of Ceralasertib and Durvalumab combination will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data
Time frame: Up to 30 months
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