Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III)
Conditions
Brief summary
PFS using BICR assessments according to RECIST 1.1
Detailed description
OS and OS24 ORR, Rate of CR, DoR, DCR, and TTDM using BICR assessments according to RECIST 1.1 PFS2 as defined by local standard clinical practice Concentration of durvalumab in blood (such as peak and trough concentration, as data allow; sparse sampling) ADA (confirmatory results: positive or negative; titers [ADA neutralizing antibodies will also be assessed]), Presence of ADA for durvalumab (confirmatory results: positive or negative; titers); EORTC QLQ-C30 and QLQ-LC13: Change in symptoms, functioning, and global health status/QoL Safety objective: to assess the safety and tolerability profile of durvalumab + SoC CRT compared with placebo + SoC CRT
Interventions
DRUGINFLIXIMAB
DRUGMYCOPHENOLIC ACID
DRUGSALINE
DRUGETOPOSIDE
DRUGCARBOPLATIN
DRUGPEMETREXED
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGCISPLATIN
DRUGPACLITAXEL
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS using BICR assessments according to RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| OS and OS24 ORR, Rate of CR, DoR, DCR, and TTDM using BICR assessments according to RECIST 1.1 PFS2 as defined by local standard clinical practice Concentration of durvalumab in blood (such as peak and trough concentration, as data allow; sparse sampling) ADA (confirmatory results: positive or negative; titers [ADA neutralizing antibodies will also be assessed]), Presence of ADA for durvalumab (confirmatory results: positive or negative; titers); EORTC QLQ-C30 and QLQ-LC13: Change in symptoms, functioning, and global health status/QoL Safety objective: to assess the safety and tolerability profile of durvalumab + SoC CRT compared with placebo + SoC CRT | — |
Countries
Hungary, Poland
Outcome results
None listed