CASPIAN
Trial question
What is the role of first-line durvalumab plus platinum-etoposide in patients with extensive-stage small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 537
537 patients (163 female, 374 male)
Inclusion criteria: adult patients with untreated extensive-stage small cell lung cancer
Key exclusion criteria: history of radiotherapy to the chest or planned consolidation chest radiotherapy; active or previous autoimmune or inflammatory disorders; paraneoplastic syndrome of autoimmune nature requiring systemic treatment; active primary immunodeficiency; uncontrolled, concurrent illness or active infections
Interventions
N=268 durvalumab plus platinum-etoposide (four cycles of platinum-etoposide plus durvalumab 1,500 mg)
N=269 platinum-etoposide (platinum-etoposide alone)
Primary outcome
Median overall survival
13
10.3
13.0 months
9.8 months
6.5 months
3.3 months
0.0 months
Durvalumab plus
platinum-etoposide
Platinum-etoposide
Significant
increase ▲
Significant increase in median overall survival (13 months vs. 10.3 months; HR 1.37, 95% CI 1.1 to 1.7)
Secondary outcomes
Borderline significant decrease in median progression-free survival (5.1 months vs. 5.4 months; HR 0.78, 95% CI 0.65 to 0.94)
Borderline significant increase in confirmed objective response (68% vs. 58%; OR 1.56, 95% CI 1.1 to 2.22)
Safety outcomes
No significant differences in adverse events, death due to adverse events.
Conclusion
In adult patients with untreated extensive-stage small cell lung cancer, durvalumab plus platinum-etoposide was superior to platinum-etoposide with respect to median overall survival.
Reference
Luis Paz-Ares, Mikhail Dvorkin, Yuanbin Chen et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939.
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