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

Conditions

• Small Cell Lung Carcinoma Extensive Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Dec 16, 2020

Status verified

Dec 2024

Primary completion

Jun 21, 2023

Completion

Jun 21, 2023

Study Design

Enrollment

101 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab in Combination with Platinum-Etoposide
  Durvalumab 1500 mg via IV infusion 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 post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.

Primary Outcome Measure

Number of Patients With Adverse Events (AEs) Grade ≥ 3 [ Time Frame: During study treatment, until disease progression (median 6 months) ]