Durvalumab
DrugDurvalumab IV (intravenous infusion)
NCT Number: NCT05221840
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Research Site, Box Hill, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Durvalumab IV (intravenous infusion)
Oleclumab IV (intravenous infusion)
Monalizumab IV (intravenous infusion)
Placebo IV (intravenous infusion)
Time frame: Up to 5 years after first patient randomized.
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
Time frame: Up to 9 years after first patient randomized
Overall survival (OS)
Time frame: Up to 5 years after first patient randomized
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Time frame: Up to 9 years after first patient randomized
Overall survival (OS) at 24 months
Time frame: Up to 5 years after first patient randomized
Duration of response (DoR) per RECIST 1.1 as assessed by BICR
Time frame: From date of randomization until 24 months
Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR
Time frame: Up to 5 years after first patient randomized
Time from randomization to second progression (PFS2)
Time frame: Up to 5 years after first patient randomized
Time from randomization to first date of distant metastasis or death (TTDM)
Time frame: Up to 9 years after first patient randomized
Time from randomization to start date of first subsequent therapy (TFST)
Time frame: Up to 5 years after first patient randomized
Progression free survival (PFS) as assessed by Investigator
Time frame: Up to 5 years after first patient randomized
IHC analysis of PD-L1 TC expression relative to efficacy outcomes
Time frame: From date of randomization until 3 months after date of last IP dose
To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations
Time frame: From date of randomization until 3 months after date of last IP dose
The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs)
Time frame: Up to 5 years after last patient randomized
Time to deterioration in pulmonary symptoms (TTFCD)
Time frame: From date of randomization until 3 months after last dose of IP
To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations
Time frame: From date of randomization until 3 months after last dose of IP
To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations
AstraZeneca
Industry
A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy
Acronym: PACIFIC-9
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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