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Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

NCT03519971 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2025-10-28

Study results available
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Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care \[SoC\] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

Conditions

Interventions

DRUG

Durvalumab

Durvalumab IV (intravenous infusion)

OTHER

Placebo

Placebo IV (intravenous infusion)

DRUG

Cisplatin/ Etoposide

Cisplatin/ Etoposide, as per standard of care

DRUG

Carboplatin/ Paclitaxel

Carboplatin /Paclitaxel, as per standard of care

DRUG

Pemetrexed/ Cisplatin

Pemetrexed / Cisplatin, as per standard of care

DRUG

Pemetrexed/ Carboplatin

Pemetrexed / Carboplatin , as per standard of care

RADIATION

Radiation

5 fractions/ week for \~6 weeks (±3 days) (Total 60 Gy)

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Bradley, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2023-09-07
Completion
2025-12-01
FDA Drug
Yes

Countries

  • Brazil
  • Czechia
  • Hungary
  • India
  • Japan
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Thailand
  • Turkey (Türkiye)
  • 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 NCT03519971 on ClinicalTrials.gov