MedTrace Logo

Early Switch Maintenance vs Delayed Second-line Nivolumab in Advanced Stage Squamous Non-small Cell Lung Cancer (NSCLC) Patients (EDEN Trial)

NCT03542461 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2022-10-03

No results posted yet for this study

Summary

The study's hypothesis is that using Nivolumab as early switch maintenance, after 4-6 cycles of standard first-line chemotherapy, might improve survival in patients with advanced stage squamous NSCLC.

Conditions

  • Squamous Non-small Cell Lung Cancer

Interventions

DRUG

Nivolumab 10 MG/ML Intravenous Solution

240 mg as a 30 minutes IV infusion on Day 1 of each treatment cycle every 2 weeks, until intolerable toxicity or patient refusal or investigator's decision. In case of disease progression the treatment should be discontinued unless documented clinical benefits in the Investigator's judgement (no rapid progression, tolerance of trial drug, stable performance status, treatment maintenance does not delay an imminent intervention to prevent serious complication of PD) and no evidence of further progression at a radiographic assessment performed within 6 weeks. No dose escalations or reduction allowed. Administration delay until 6 weeks as well as resuming dose are allowed according to protocol defined criteria.

OTHER

Best Supportive Care

Care that aims to optimize the comfort, function and social support of the patients and their family at all stages of the illness. Best Supportive Care (BSC)includes the use of analgesics, antibiotics, blood tranfusions, blood products, radiotherapy, corticosteroids, antiemetics, antidiarrheals, vitamins and any intervention aiming the improvement of patient's discomfort. Any chemotherapy, immunotherapy and targeted therapy are not considered as part of BSC.

Sponsors & Collaborators

  • Mipharm S.p.A.

    collaborator UNKNOWN

  • Bioikos Ambiente Srl

    collaborator OTHER

  • Istituto Toscano Tumori

    collaborator OTHER

  • Temas srl

    collaborator UNKNOWN

  • Bristol Myers Squibb Srl Italia

    collaborator UNKNOWN

  • Gruppo Oncologico Italiano di Ricerca Clinica

    lead OTHER

Principal Investigators

  • Andrea Ardizzoni, Dr · Medical Oncology Unit - S.Orsola Malpighi University Hospital of Bologna

  • Marcello Tiseo, Dr · Medical Oncology Unit - University Hospital of Parma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT03542461 on ClinicalTrials.gov