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Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

NCT03703297 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2025-11-21

Study results available
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Summary

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Conditions

Interventions

DRUG

Durvalumab

Durvalumab IV (intravenous infusion)

DRUG

Tremelimumab

Tremelimumab IV (intravenous infusion)

OTHER

Placebo

Placebo IV (intravenous infusion)

Sponsors & Collaborators

Principal Investigators

  • Haiyi Jiang, M.D. · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2024-01-15
Completion
2026-10-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • China
  • Czechia
  • Germany
  • India
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03703297 on ClinicalTrials.gov