Active — Not RecruitingPhase 3

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

United States987 participantsStarted 2017-03-27

Plain-language summary

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

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP

Timeframe: From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).

OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP

Timeframe: From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).

OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP

Timeframe: From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).

OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP

Timeframe: From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).

Trial details

NCT IDNCT03043872

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-27

Results submitted2021-01-21

View on ClinicalTrials.gov More Small Cell Lung Carcinoma Extensive Disease trials