Phase 3
Completed N=713
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT02125461 ↗Enrolled (actual)
713
Serious AEs
27.1%
Results posted
Jan 2019
Primary outcomePrimary: Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) — 16.8; 5.6 Months — p=<0.0001
◆ Published Evidence
Highly cited
1,307citations · ~327 / year
Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.
Summary
A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
Linked Publications (5)
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Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer.
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Brief Report: Durvalumab After Chemoradiotherapy in Unresectable Stage III EGFR-Mutant NSCLC: A Post Hoc Subgroup Analysis From PACIFIC.
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Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial.
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Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial.
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Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) |
16.8; 5.6 | <0.0001 sig |
| PRIMARY Overall Survival |
NA; 28.7 | 0.00251 sig |
| SECONDARY Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1 |
30.0; 17.8 | <0.001 sig |
| SECONDARY Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1 |
NA; 18.4 | — |
| SECONDARY Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1 |
55.9; 35.3 | — |
| SECONDARY Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1 |
44.2; 27.0 | — |
| SECONDARY Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1 |
28.3; 16.2 | <0.0001 sig |
| SECONDARY Percentage of Patients Alive at 24 Months (OS24) |
66.3; 55.6 | 0.005 sig |
| SECONDARY Time to Second Progression or Death (PFS2) |
28.3; 17.1 | <0.0001 sig |
| SECONDARY Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) |
7.4; 5.7 | 0.664 |
| SECONDARY Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13) |
2.8; 3.7; 5.6; 5.6; NA; 29.6 | 0.522 |
| SECONDARY Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations |
191.00; 120.00; 177.00; 373.00; 186.00 | — |
| SECONDARY Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab |
19; 10; 8; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age at least 18 years.
- Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
- Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
- World Health Organisation (WHO) Performance Status of 0 to 1.
- Estimated life expectancy of more than 12 weeks.
Exclusion Criteria
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
- Active or prior autoimmune disease or history of immunodeficiency.
- Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
- Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
Data sourced from ClinicalTrials.gov (NCT02125461) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.