NCT03975114

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

A Randomized Phase 2 Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

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

Timeline

• Start date: 2018-12-20
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2019-06-05
• Last updated: 2023-03-24

Locations

1 site across 1 country: Italy