A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLC

Sponsor
University Hospital Regensburg
Study ID
NCT02852083
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Pioglitazone — DRUG
    Pioglitazone 25 mg once daily, p.o.
  • nivolumab — DRUG
    3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment)
  • Treosulfan — DRUG
    Treosulfan 250 mg twice daily, p.o.
  • Clarithromycin — DRUG
    Clarithromycin 250 mg twice daily p.o.

Study Details

This is a Phase II, multicentre, open-label, randomized, and controlled study, evaluating the efficacy and safety of combined modularized treatment of treosulfan, pioglitazone and clarithromycin in patients with with squamous and non- squamous cell lung cancer, respectively after platin failure.

Key Dates

Start date
Jan 31, 2016
Status verified
Jan 2018
Primary completion
Jul 31, 2019
Completion
Jul 31, 2020

Study Design

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

Arms

  • Experimental: A: Biomodulatory treatment
    treosulfan 250 mg p.o. twice daily, pioglitazone 45 mg p.o. once daily, clarithromycin 250 mg p.o. twice daily until progression or no clinical benefit observed, whichever comes first.
  • Active Comparator: B: Standard Treatment
    Nivolumab, 3 mg per kilogram of body weight every 2 weeks until disease progression according to RECIST 1.1 or unacceptable toxicity

Primary Outcome Measure

Progression Free Survival [ Time Frame: up to 6 months after study completion ]

Central Contacts

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