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A Phase III, Randomised, Double blind, Placebo controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum based Concurrent Chemoradiation Therapy (PACIFIC-8)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506891-28-00
Acronym
D9075C00001
Enrollment
280
Registered
2024-01-31
Start date
2022-05-02
Completion date
Unknown
Last updated
2025-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

DRUGDOMVANALIMAB
DRUGPLACEBO
DRUGINFLIXIMAB
DRUGMYCOPHENOLATE MOFETIL
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026