MedTrace Logo

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

NCT04712903 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-01-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Small Cell Lung Carcinoma Extensive Disease

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Dolores Isla, M.D. · Hospital Clínico Lozano Blesa, Zaragoza

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2023-06-21
Completion
2023-06-21
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712903 on ClinicalTrials.gov