Locally-advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Conditions
Brief summary
Assessment of PFS by BICR in TROP2 biomarker positive participants., Assessment of OS in TROP2 biomarker positive participants.
Detailed description
Assessment of PFS by BICR in the FAS population., Assessment of OS in the FAS population., Objective Response Rate (ORR), Duration of Response (DoR), Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab, Pharmacokinetics (PK), Immunogenicity, Second Progression-Free Survival (PFS2), Safety and tolerabillity evaluated in terms of AEs
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGINFLIXIMAB
DRUGRilvegostomig
DRUGDatopotamab deruxtecan
DRUGMYCOPHENOLATE MOFETIL
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of PFS by BICR in TROP2 biomarker positive participants., Assessment of OS in TROP2 biomarker positive participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PFS by BICR in the FAS population., Assessment of OS in the FAS population., Objective Response Rate (ORR), Duration of Response (DoR), Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab, Pharmacokinetics (PK), Immunogenicity, Second Progression-Free Survival (PFS2), Safety and tolerabillity evaluated in terms of AEs | — |
Countries
Austria, Belgium, Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed