Non-small Cell Lung Cancer Stage IV Clinical Trial
Official title:
Maintenance Metronomic Per OS Navelbine In Advanced NSCLC Patients After Previous Platinum Based Chemotherapy: A Multicenter Randomized Best Supportive Care Controlled Phase II Study - MA.NI.LA. Trial
Non Small Cell Lung Cancer (NSCLC) represents the first cancer related cause of death
worldwide with 1.4 millions of deaths every years. Current standard therapies include
platinum-containing drugs but at one year from diagnosis the survival rate is still low
(30-40%) .
The purpose of this study is to evaluate the role of a platinum-free drug, named Vinorelbine,
administered by the so called "metronomic schedule" in order to prolong the progression free
survival of patients.
Systemic therapy remains the mainstay of treatment of advanced stage NSCLC. Combination
chemotherapy with a platinum-based regimen has emerged as standard therapy for patients with
advanced stage disease. Observations supported by the findings of several clinical trial,
established the notion that an efficacy plateau had been reached in advanced stage NSCLC
patients treated with platinum-containing drugs.
Recent phase III trials suggest the benefit of "switch" and "continuing" maintenance
treatment with different drugs. As "switched therapy", Vinorelbine has been selected on the
base of its anti-mitotic role. In fact, the use of anti-mitotic drugs at lower dose but with
higher frequency (metronomic schedule) seems to augment the anti-angiogenetic effect of this
kind of drugs, thus augmenting the efficacy of the therapy.
Therefore, the purpose of the current study is to evaluate the role of a "switched
maintenance" with oral vinorelbine administered as a metronomic schedule in terms of
Progression Free Survival (PFS) in advanced NSCLC patients with stable disease after first
line platinum based chemotherapy.
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