A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06606847
- Lead Sponsor
- AstraZeneca
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Durvalumab durvalumab plus oleclumab as an IV infusions Arm 1 Oleclumab durvalumab plus oleclumab as an IV infusions
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) at 12 months From date of first dose until 12 months PFS12 is defined as the Kaplan-Meier estimate of PFS at 12 months per RECIST 1.1 as assessed by the investigator.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) at 6, 18, and 24 months From date of first dose until 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.
Progression Free Surival (PFS) Up to 24 months after the last patient's first dose 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.
Overall survival (OS) at 12 and 24 months From date of first dose until 12 and months, respectively OS12 and OS24 are defined as the Kaplan-Meier estimate of OS at 12 months and 24 months respectively
Overall Survival (OS) Up to 24 months after the last patient's first dose OS is defined as time from the start of treatment until the date of death due to any cause
Objective response rate (ORR) Up to 24 months after the last patient's first dose 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
Duration of response (DoR) Up to 24 months after the last patient's first dose 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 to Response (TTR) Up to 24 months after the last patient's first dose 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
Trial Locations
- Locations (1)
Research Site
🇷🇺Ufa, Russian Federation