Efficacy and Safety Study of a New Therapeutic Strategy in the Treatment of Extended-Disease Small-Cell Lung Cancer
Status:
Recruiting
Trial end date:
2024-10-17
Target enrollment:
Participant gender:
Summary
Small cell lung cancer (SCLC) is an aggressive type of neuroendocrine tumor with the majority
of patients (about 60-70%) being diagnosed with metastatic disease and with a median survival
ranging from 7 to 12 months. Combination chemotherapy (CT), namely a platinum and
etoposide-based regimen, represents the cornerstone of treatment for extended disease (ED)
SCLC. Despite this the duration of response is short and nearly all patients develop disease
relapse or progression. The recent approval of atezolizumab in combination with carboplatin
and etoposide as first line in patients with ED SCLC is surely a step forward in the
understanding the molecular landscape and treatment of this complex tumor, but new
therapeutic approaches need to be explored.
This trial aims to assess the efficacy in terms of 1 year survival a new therapeutic strategy
that combines to the standard CT (carboplatin and etoposide), two drugs indicated in the
tratment of several types of tumors: bevacizumab and atezolizomab.
The treatment will start with an induction phase during which eligible patients will receive,
by intravenous way, a combination of the above mentioned drugs according to a specific
administration regimen. This phase will last about 18 weeks. Therafter the treatment will
proceed with a maintenence phase lasting for a maximum of 54 weeks during which the patients
will receive only atezolizumab and bevacizumab, by intravenous way, according to a specific
administration regimen. Treatment will be discontnued in case of disease progression,
unacceptable toxicity, patient refusal or loss of clinical benefit (for atezolizumab). During
the study period the patients will undergo to periodic visits and laboratory, radiologic
assessments to monitor the efficacy and the safety of the ongoing treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
Collaborators:
Dr. Luca Boni U.O. Epidemiologia Clinica, IRCCS Ospedale Policlinico San Martino - IST NORD CBA Roche Pharma, Italy YGHEA, CRO Division of Ecol Studio spa