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Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION)

NCT03345810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-06-15

No results posted yet for this study

Summary

AIO-YMO/TRK-0416 (DURATION) is a open-label, treatment stratified and randomized phase II study of Durvalumab, frail or elderly patients with metastatic non-squamous NSCLC with no targetable molecular alterations (EGFRwt; ALKtransl-) and not amenable to cisplatinum-based standard-combination chemotherapy but eligible for at-least mono-chemotherapy with gemcitabine or vinorelbine.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Metastatic Lung Cancer
  • Non Small Cell Lung Cancer
  • Lung Adenocarcinoma Metastatic
  • Large Cell Lung Carcinoma Metastatic

Interventions

DRUG

Durvalumab

Induction: (1125 mg) cycle Q3W Maintenance: (1500 mg) cycle Q4W

DRUG

Vinorelbine

(30 mg/m2 D1 + D8 as infusion) cycle Q3W

DRUG

Gemcitabine

(1000 mg/m2 D1 + D8 as infusion) cycle Q3W

DRUG

nab-Paclitaxel

(100 mg/m2 intravenous infusion over 30 minutes on D1, D8) cycle Q3W

DRUG

Carboplatin

(AUC = 5 mg•min/mL on Day 1) cycle Q3W

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Celgene

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Jonas Kuon, Dr · Department of Thoracic Oncology, Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-14
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Germany

Study Locations

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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 NCT03345810 on ClinicalTrials.gov