A Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5)

Sponsor
National Cancer Institute, Naples
Study ID
NCT03975114
Phase
PHASE2
Status
Unknown

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Chemotherapy — DRUG
    Any approved first line chemotherapy regimen at Investigators' choice
  • Durvalumab — DRUG
    Durvalumab 1500 mg iv Q4w until progressive or unacceptable toxicity or patient's refusal
  • Tremelimumab — DRUG
    Tremelimumab 75 mg iv Q4w for 4 administrations (4 months)

Study Details

This is a randomized phase 2 trial aiming to assess the early efficacy of two experimental treatment sequences. Three arms are planned; (i) standard chemotherapy followed at progression by single agent immunotherapy with durvalumab (CT), (ii) experimental single agent immunotherapy with durvalumab followed at progression by chemotherapy, (iii) experimental combination immunotherapy with durvalumab+tremelimumab followed at progression by chemotherapy. The the two experimental strategies will be compared with the standard strategy in terms of 12-month overall survival, time considered informative for the type of treatment and disease

Key Dates

Start date
Dec 20, 2018
Status verified
Mar 2023
Primary completion
Dec 31, 2023
Completion
Jun 30, 2024

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Chemo first
    Standard chemotherapy followed at progression by durvalumab
  • Experimental: Immuno Monotherapy first
    Experimental single agent immunotherapy with durvalumab followed at progression by chemotherapy
  • Experimental: Immuno Combination Therapy first
    experimental single agent immunotherapy with durvalumab followed at progression by chemotherapy

Primary Outcome Measure

12-month overall survival [ Time Frame: 12 months ]

Central Contacts

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