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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03345810
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Induction: (1125 mg) cycle Q3W Maintenance: (1500 mg) cycle Q4W
  • Vinorelbine — DRUG
    (30 mg/m2 D1 + D8 as infusion) cycle Q3W
  • Gemcitabine — DRUG
    (1000 mg/m2 D1 + D8 as infusion) cycle Q3W
  • nab-Paclitaxel — DRUG
    (100 mg/m2 intravenous infusion over 30 minutes on D1, D8) cycle Q3W
  • Carboplatin — DRUG
    (AUC = 5 mg•min/mL on Day 1) cycle Q3W

Study Details

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.

Key Dates

Start date
Dec 14, 2017
Status verified
Jun 2023
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Arm A
    Frail or elderly patients with metastatic NSCLC; CARG- Score ≤ 3 Carboplatin (AUC 5.0; D1) + nab-Paclitaxel (100mg/m2 D1,D8) Q3W
  • Experimental: Experimental Arm B
    Frail or elderly patients with metastatic NSCLC; CARG- Score ≤ 3 Induction:Carboplatin (AUC 5.0; D1) + nab-Paclitaxel (100mg/m2) D1,D8; Q3W \[2 cyc\] followed by durvalumab (1125 mg; Q3W) \[ 2 cyc\] Maintenance:durvalumab (1500 mg) Q4W
  • Experimental: Experimental Arm C
    Frail or elderly patients with metastatic NSCLC; CARG- Score \> 3 Induction: Vinorelbine (30 mg/m2; D1+D8) Q3W \[ 2 cyc\] or Gemcitabine (1000 mg/m2; D1+D8) Q3W \[ 2 cyc\] followed by durvalumab (1125 mg) Q3W \[2 cyc\] Maintenance:durvalumab (1500 mg; Q4W)
  • Active Comparator: Control Arm D
    Frail or elderly patients with metastatic NSCLC; CARG- Score \> 3 Vinorelbine (30 mg/m2; D1+D8) Q3W or Gemcitabine (1000 mg/m2; D1+D8) Q3W

Primary Outcome Measure

Rate of treatment related Grade III/IV adverse events (CTCAE V4.03) [ Time Frame: through study completion, an average of 24 months ]

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