NCT04712903

Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer

A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.

Detailed description

This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity. Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.

Conditions

• Small Cell Lung Carcinoma Extensive Disease

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
DRUG	Cisplatin	Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.
DRUG	Etoposide	Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.
DRUG	Carboplatin	Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.

Timeline

• Start date: 2020-12-16
• Primary completion: 2023-06-21
• Completion: 2023-06-21
• First posted: 2021-01-15
• Last updated: 2025-01-07
• Results posted: 2025-01-07

Locations

34 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study