Skip to content
DataLookout
Start free
Menu

PACIFIC-9NCT05221840

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 3 months later.

See at-risk trials from AstraZeneca

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 42 versions: 41 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 30, 2026 to Jan 8, 2027
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 3 of 202 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion pushed from Jun 30, 2026 to Sep 30, 2026v41
  3. Site details revised at 1 of 202 sitesv40
  4. Enrollment target: 1027 to 1051v39
  5. Trial status: Recruiting to Active, Not Recruitingv38 Show 4 more changesShow less
    • Enrollment target: estimated 999 to confirmed 1027
    • Study sites: 240 to 202
    • Primary completion date: May 29, 2026 to Jun 30, 2026
    • Study completion date: May 31, 2030 to Jul 2, 2030
Show 35 earlier versionsHide 35 earlier versions
  1. Site details revised at 22 of 240 sitesv37
  2. Site details revised at 14 of 240 sitesv36
  3. Site details revised at 5 of 240 sitesv35
  4. Site details revised at 4 of 240 sitesv34
  5. Site details revised at 2 of 240 sitesv33
  6. Site details revised at 4 of 240 sitesv32
  7. Site details revised at 17 of 240 sitesv31
  8. Site details revised at 8 of 240 sitesv30
  9. Site details revised at 52 of 240 sitesv29
  10. Study sites: 238 to 240v28
  11. Study sites: 235 to 238v27
  12. Study sites: 232 to 235v25
  13. Study sites: 227 to 232v24
  14. Site details revised at 2 of 227 sitesv23
  15. Study sites: 225 to 227v22
  16. Study sites: 223 to 225v21
  17. Study sites: 222 to 223v20
  18. Study sites: 221 to 222v19
  19. Study sites: 217 to 221v18
  20. Study sites: 221 to 217v17
  21. Study sites: 220 to 221v16
  22. Study sites: 218 to 220v15
  23. Study sites: 217 to 218v14
  24. Study sites: 216 to 217v13
  25. Study sites: 213 to 216v12
  26. Study sites: 205 to 213v11
  27. Study sites: 197 to 205
    • Eligibility criteria expanded, about 4 words
    v10
  28. Study sites: 189 to 197v9
  29. Study sites: 186 to 189v8
  30. Study sites: 164 to 186v7
  31. Study sites: 162 to 164v6
  32. Study sites: 156 to 162v5
  33. Study sites: 129 to 156v4
  34. Study sites: 88 to 129
    • Primary completion date: Jun 18, 2026 to May 29, 2026
    • Study completion date: Oct 18, 2030 to May 31, 2030
    v3
  35. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Enrollment target: 1000 to 999
    • Study sites: 67 to 88
    • Start date changed from estimate of Feb 18, 2022 to Feb 7, 2022
    • Interventions: Monalizumab (Drug), Oleclumab (Drug), Placebo (Other), durvalumab (Drug) to Durvalumab (Drug), Monalizumab (Drug), Oleclumab (Drug), Placebo (Other)
    • Secondary endpoints: details revised at 1 of 15 entries
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression Free Surival (PFS)
Timeframe: Up to 5 years after first patient randomized.

Secondary (15)

Overall Survival (OS)
Objective response rate (ORR)
Overall survival (OS) at 24 months
Duration of response (DoR)
Progression free survival (PFS) at 6, 12, 18, and 24 months
Show 10 moreShow less
Time from randomization to second progression (PFS2)
Time from randomization to first date of distant metastasis or death (TTDM)
Time from randomization to start date of first subsequent therapy (TFST)
Progression free survival (PFS) as assessed by Investigator
IHC analysis of PD-L1 TC expression
Concentration of Durvalumab
Anti-drug antibodies (ADAs)
Time to deterioration in pulmonary symptoms (TTFCD)
Concentration of Oleclumab
Concentration of Monalizumab

Arms and interventions

Arm A: Durvalumab and OleclumabExperimental

Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months

Arm B: Durvalumab and MonalizumabExperimental

Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only

Arm C: Durvalumab and PlaceboActive comparator

Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months

Drugs: Durvalumab, Oleclumab, Monalizumab

Other: Placebo

Sites

202 sites in 20 countries

United States 33, China 28, Brazil 12, France 12, Japan 11, United Kingdom 11, Thailand 10, Australia 9, Germany 9, Canada 8, Italy 8, South Korea 8, Poland 7, Spain 7, Taiwan 7, Portugal 6, Turkey (Türkiye) 6, Colombia 4, Peru 3, Vietnam 3