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Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)

NCT03043872

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Small Cell Lung Carcinoma Extensive Disease

Interventions: Durvalumab, Tremelimumab, Carboplatin, Cisplatin, Etoposide

Countries: United States, Argentina, Austria, Brazil, Bulgaria, China, Czechia, France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

1. 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.
2. Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
3. Life expectancy ≥12 weeks at Day 1.
4. ECOG 0 or 1 at enrolment.
5. No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.

Exclusion criteria:

1. Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
2. Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
3. Active infection including tuberculosis, HIV, hepatitis B anc C
4. Active or prior documented autoimmune or inflammatory disorders
5. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Locations (207)
  • Birmingham, Alabama, United States
  • Scottsdale, Arizona, United States
  • Rogers, Arkansas, United States
  • Santa Monica, California, United States
  • New Haven, Connecticut, United States
  • Athens, Georgia, United States
  • Fort Wayne, Indiana, United States
  • Muncie, Indiana, United States
  • Leawood, Kansas, United States
  • Wichita, Kansas, United States
  • Paducah, Kentucky, United States
  • Grand Rapids, Michigan, United States
  • Mineola, New York, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Harrisburg, Pennsylvania, United States
  • Sioux Falls, South Dakota, United States
  • Nashville, Tennessee, United States
  • Kennewick, Washington, United States
  • Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Mar del Plata, Argentina
  • Rosario, Argentina
  • San Miguel de Tucumán, Argentina
  • Linz, Austria
  • Salzburg, Austria
  • Vienna, Austria
  • Vienna, Austria
  • Barretos, Brazil
  • Curitiba, Brazil
  • + 177 more on CT.gov