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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Durvalumab; Etoposide; Etoposide phosphate; Tremelimumab

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.