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Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

NCT04449861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-11-27

Study results available
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Summary

This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.

Conditions

  • Small Cell Lung Carcinoma Extensive Disease

Interventions

DRUG

Durvalumab plus chemotherapy

Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria. Drug: Carboplatin 4-6 cycles every 3 weeks Drug: Cisplatin 4-6 cycles every 3 weeks Drug: Etoposide 4-6 cycles every 3 weeks

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04449861 on ClinicalTrials.gov