PACIFIC
Trial question
What is the role of durvalumab in patients with unresectable, stage III non-small cell lung cancer and no disease progression after concurrent chemoradiotherapy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.7% female
70.3% male
N = 709
709 patients (213 female, 500 male)
Inclusion criteria: patients with unresectable, stage III non-small cell lung cancer and no disease progression after concurrent chemoradiotherapy
Key exclusion criteria: unresolved grade > 2 toxicities; or grade ≥ 2 pneumonitis and/or radiation pneumonitis from prior chemoradiotherapy
Interventions
N=476 durvalumab (10 mg/kg IV, administered once every 2 weeks for 12 months)
N=237 placebo (matching placebo)
Primary outcome
Median overall survival
47.5
29.1
47.5 months
35.6 months
23.8 months
11.9 months
0.0 months
Durvalumab
Placebo
Significant
increase ▲
Significant increase in median overall survival (47.5 months vs. 29.1 months; HR 1.7, 95% CI 1.1 to 1.7)
Secondary outcomes
Significant increase in progression-free survival (16.9 months vs. 5.6 months; HR 1.8, 95% CI 1.5 to 2.2)
Significant increase in median time to death or distant metastasis (36.5 months vs. 17.7 months; HR 1.7, 95% CI 1.35 to 2.1)
Conclusion
In patients with unresectable, stage III non-small cell lung cancer and no disease progression after concurrent chemoradiotherapy, durvalumab was superior to placebo with respect to median overall survival.
Reference
David R Spigel, Corinne Faivre-Finn, Jhanelle E Gray et al. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311.
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