Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Running, not enrolling · Phase 3
Conditions studied: Small Cell Lung Carcinoma Extensive Disease
In brief
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer
Key facts
- Study ID
- NCT03043872
- Run by
- AstraZeneca
- People needed
- 987
- Starts
- 2017-03-27
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
- Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
- Life expectancy ≥12 weeks at Day 1.
- ECOG 0 or 1 at enrolment.
- No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
You may not qualify if…
- Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
- Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
- Active infection including tuberculosis, HIV, hepatitis B anc C
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Where it is running
- Research Site — Scottsdale, Arizona, United States
- Research Site — Rogers, Arkansas, United States
- Research Site — Santa Monica, California, United States
- Research Site — New Haven, Connecticut, United States
- Research Site — Athens, Georgia, United States
- Research Site — Fort Wayne, Indiana, United States
- Research Site — Muncie, Indiana, United States
- Research Site — Leawood, Kansas, United States
- Research Site — Wichita, Kansas, United States
- Research Site — Paducah, Kentucky, United States
- Research Site — Grand Rapids, Michigan, United States
- Research Site — Mineola, New York, United States
- Research Site — Cleveland, Ohio, United States
- Research Site — Columbus, Ohio, United States
- Research Site — Harrisburg, Pennsylvania, United States
- Research Site — Sioux Falls, South Dakota, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Kennewick, Washington, United States
- Research Site — Buenos Aires, Argentina
- Research Site — Ciudad de Buenos Aires, Argentina
- Research Site — Mar del Plata, Argentina
- Research Site — Rosario, Argentina
- Research Site — San Miguel de Tucumán, Argentina
- Research Site — Linz, Austria
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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