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Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy

NCT04351256 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-03-27

No results posted yet for this study

Summary

This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty).

Conditions

  • NSCLC, Stage III

Interventions

DRUG

Durvalumab Injection [Imfinzi]

Durvalumab fixed dose of 1,500 mg

RADIATION

Thoracic Radiotherapy (TRT) conventionally

Conventionally fractionated TRT consisting of 30 x 2 Gy (60 Gy) within 6 weeks

RADIATION

Thoracic Radiotherapy (TRT) hypofractionated

Hypofractionated TRT consisting of 20 x 2,75 Gy (55 Gy) within 4 weeks

Sponsors & Collaborators

  • Thoraxklinik-Heidelberg gGmbH

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Farastuk Bozorgmehr, Dr. med. · Dept. of Thoracic Oncology Thoraxklinik at Heidelberg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2026-01-21
Completion
2026-01-21

Countries

  • Germany

Study Locations

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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 NCT04351256 on ClinicalTrials.gov