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

NCT03975114 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2023-03-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Francesco Perrone, MD, PhD · Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Italy

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 NCT03975114 on ClinicalTrials.gov