The purpose of this Phase II, open-label, multicentre, single-arm study is to assess efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) in participants with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), who have not progressed following platinum-based concurrent or sequential chemoradiotherapy (cCRT or sCRT).
This is a Phase II, open-label, multicentre, single-arm study assessing the efficacy and safety of durvalumab in combination with oleclumab in participants with locally advanced (Stage III), unresectable NSCLC with WHO performance status of 0 or 1, who have not progressed on prior platinum-based CRT. All participants will be assigned to receive durvalumab and oleclumab as an IV infusions for up to 12 months (last dose should be administered at week 48). The last administration at Week 48, or until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or an intervention discontinuation criterion is met. The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oleclumab IV (intravenous infusion)
Durvalumab IV (intravenous infusion)
Research Site
Kazan', Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Progression free survival (PFS) at 12 months
PFS12 is defined as the Kaplan-Meier estimate of PFS at 12 months per RECIST 1.1 as assessed by the investigator.
Time frame: From date of first dose until 12 months
Progression free survival (PFS) at 6, 18, and 24 months
PFS6, PFS18 and PFS24 are defined as the Kaplan-Meier estimate of PFS at 6 months, 18 months and 24 months respectively, per RECIST 1.1 as assessed by the investigator.
Time frame: From date of first dose until 24 months
Progression Free Surival (PFS)
PFS is defined as time from the start of treatment until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause.
Time frame: Up to 24 months after the last patient's first dose
Overall survival (OS) at 12 and 24 months
OS12 and OS24 are defined as the Kaplan-Meier estimate of OS at 12 months and 24 months respectively
Time frame: From date of first dose until 12 and months, respectively
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 24 months after the last patient's first dose
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR), as determined by the investigator per RECIST 1.1
Time frame: Up to 24 months after the last patient's first dose
Duration of response (DoR)
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Research Site
Nizhny Novgorod, Russia
Research Site
Novosibirsk, Russia
Research Site
Obninsk, Russia
Research Site
Saint Petersburg, Russia
Research Site
Saint Petersburg, Russia
Research Site
Ufa, Russia
...and 1 more locations
DoR is defined as the time from first response until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause
Time frame: Up to 24 months after the last patient's first dose
Time to Response (TTR)
TTR is defined as the time from the start of the treatment to the first documented objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST 1.1
Time frame: Up to 24 months after the last patient's first dose