A PHASE II TRIAL ON NON-SMALL-CELL LUNG CANCER STEM CELLS SENSITIVITY ASSAY (LUCAS)

Conditions: Histologically/cytologically confirmed diagnosis of metastatic NSCLC.Possibility to obtain tumor tissue form primary tumor or from an accessible metastatic site, or possibility to collect any neoplastic effusion.Performance status of 0-1 according to ECOG score.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-001440-22-IT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Histologically/cytologically confirmed diagnosis of metastatic NSCLC.
Possibility to obtain tumor tissue form primary tumor or from an accessible metastatic site, or possibility to collect any neoplastic effusion.
Performance status of 0-1 according to ECOG score.
At least one measurable lesion according to RECIST criteria.
At least one previous standard chemotherapy regimen and previous therapy with an EGFR-TKI if EGFR mutated or crizotinib (or other anti ALK agent) if ALK positive.
Adequate hematological, renal and liver functions.
Radiological evidence of disease progression to the last anticancer therapy.
At least 21 days since the last chemotherapy or any anticancer dose.
No concomitant comorbidity potentially interfering with the study.
If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method (intrauterine contraceptive device (IUD), birth control pills, or barrier device) during and for three months after trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

No possibility to obtain tumor tissue or neoplastic effusion.
Performance status >1 according to ECOG score.
No measurable lesion(s)
Life expectancy less than 3 months.
Important comorbidity interfering with the study.
Significant alteration of liver, hematological or renal function(s).
Brain metastases. Patients with resected brain metastases, or with asimptomatic brain metastases already treated with radiotherapy are eligible if they not need for steroids or antiepilettic drugs.No informed consent form signature

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary end-points:<br>Response rate (RR) in pretreated metastatic NSCLC Identification of the minimal in vitro CSC mortality rate translating in a clinical response according to RECIST criteria.<br>;Secondary Objective: Secondary end-point:<br>Progression-free survival (PFS)<br>Overall Survival (OS)<br>Toxicity<br>Biomarkers associate with drug sensitivity<br>;Primary end point(s): Primary end-points:<br>Response rate (RR) in pretreated metastatic NSCLC Identification of the minimal in vitro CSC mortality rate translating in a clinical response according to RECIST criteria;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end-point:<br>Progression-free survival (PFS)<br>Overall Survival (OS)<br>Toxicity<br>Biomarkers associate with drug sensitivity<br>;Timepoint(s) of evaluation of this end point: two years