NCT03345810

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to assess the safety and tolerability of sequential therapy consisting of standard of care mono- or combination chemotherapy followed by durvalumab in comparison to standard of care mono- or combination chemotherapy in frail/elderly patients.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-14
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-11-17
• Last updated: 2023-06-15

Locations

30 sites across 1 country: Germany