and who did not progress after definitive platinum based cCRT., The target population of interest in this study is participants with locally advanced (Stage III), unresectable NSCLC, whose tumours express PD L1 TC ≥ 1% as assessed by a central reference laboratory using the VENTANA PD-L1 (SP263) IHC assay
Conditions
Brief summary
Progression Free Survival (PFS) using Blinded Independent Central Review (BICR) assessment according to RECIST 1.1 with participants with PD-L1 TC>=50%. PFS will be evaluated every 00 weeks (±00 days) from randomisation through 00 weeks, and q00w (± 00 days) thereafter until RECIST 1.1 defined radiological progression, plus 1 or more follow-up scans.
Detailed description
PFS in PD-L1 TC ≥ 1% by BICR. Comparison of durvalumab + domvanalimab to durvalumab + placebo in TC ≥ 1% or TC ≥ 50% in: 1. Overall Survival (OS) 2. PFS by investigator 3. PFS6, PFS12, PFS18, PFS24 4. OS at 24 months 5. ORR and DoR by BICR 6. PFS2, TTDM, TFST 7. PK and immunogenicity of durvalumab and domvanalimab 8. Time to First Confirmed Deterioration (TTFCD) in pulmonary symptoms measured by the NSCLC-SAQ.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) using Blinded Independent Central Review (BICR) assessment according to RECIST 1.1 with participants with PD-L1 TC>=50%. PFS will be evaluated every 00 weeks (±00 days) from randomisation through 00 weeks, and q00w (± 00 days) thereafter until RECIST 1.1 defined radiological progression, plus 1 or more follow-up scans. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS in PD-L1 TC ≥ 1% by BICR. Comparison of durvalumab + domvanalimab to durvalumab + placebo in TC ≥ 1% or TC ≥ 50% in: 1. Overall Survival (OS) 2. PFS by investigator 3. PFS6, PFS12, PFS18, PFS24 4. OS at 24 months 5. ORR and DoR by BICR 6. PFS2, TTDM, TFST 7. PK and immunogenicity of durvalumab and domvanalimab 8. Time to First Confirmed Deterioration (TTFCD) in pulmonary symptoms measured by the NSCLC-SAQ. | — |
Countries
Belgium, France, Germany, Greece, Hungary, Italy, Norway, Poland, Romania, Spain