Study of AZD2811 + Durvalumab in ES-SCLC

• Status: Recruiting
• Trial end date: 2024-03-11
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Carboplatin; Cisplatin; Durvalumab; Etoposide

Criteria

Inclusion Criteria:

• Documented evidence of extensive stage SCLC (ES-SCLC)

• Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC

• No prior exposure to immune-mediated therapy

• Life expectancy ≥12 weeks at Day 1.

• ECOG 0 or 1 at enrolment.

Exclusion Criteria:

• Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy

• Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS

• Active infection including tuberculosis, HIV, hepatitis B and C

• Active or prior documented autoimmune or inflammatory disorders

• Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.