Patients with metastatic non small cell lung cancer in second line therapy
Conditions
Interventions
Trade Name: tarceva
Product Name: erlotinib
Product Code: L01XE03
Pharmaceutical Form: Capsule
INN or Proposed INN: ERLOTINIB
CAS Number: 183321-74-6
Concentration unit: mg milligram(s)
Concentration
Sponsors
department of experimental and clinical medicine "F. Magrassi"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed written informed consents • Patients be age >18 years • Patients must have histologically or cytologically confirmed non small cell carcinoma of the lung and are previously treated • Patient must have measurable stage IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the TNM classification system). • Patients must have a Life Expectancy of greater than 12 weeks. • Patients must have an ECOG performance status 0 or 1 (Karnofsky> 70%). • Patients must have normal organ and marrow function as defined below, within one week prior to randomization: - Neutrophils> 1.5 x 109/L, platelets > 100 x 109/L, and hemoglobin >9 g/dL - Bilirubin level either normalor 93%. • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • Patients must have the ability to understand and the willingness to sign a written informed consent document. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with EGFR/ALK mutated histologically proven NSCLC • Type 1 or 2 Diabetes • Patients with uncontrolled undercurrents illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements. • Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible. • Patients with uncontrolled brain metastasis. Note: Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or other agents used in the study are excluded. • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol • Any investigational agent(s) within 4 weeks prior to entry • Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy • Legal incapacity or limited legal capacity • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent • Women who are pregnant or breastfeeding • Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ? 5 years will be allowed to enter the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is a two-part trial, where a safety Run-in part of metformin combined with erlotinib will be followed by a Phase II part of metformin plus erlotinib. Primary objective of the safety run in part is to determine the MTD and the recommended Phase II dose of metformin combined with erlotinib as second-line treatmentin subjects with NSCLC harboringwild-type EGFR gene. Primaryobjective of the phase II part are: • To assess the percentage of patientswithoutdiseaseprogressionat 10 weeks. • To assess the median progression free survival of the second-line combination metformin and erlotinib in subjects with NSCLCharboring wild-type EGFR gene. ;Secondary Objective: Secondary objectives of the safety run in part are: • To assess the pharmacokinetics (PK) of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To explore antitumor activity of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To explore candidate markers or tumor characteristics predictive of antitumor activity Secondary objectives of the phase II part are: • To assess the anti-tumor activity, in terms of response rate, overall survival, QoL, of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To explore candidate markers or tumor characteristics predictive of antitumor activity ;Primary end point(s): The study is a two-part trial, where a safety Run-in part of metformin combined with erlotinib will be followed by a Phase II part of metformin plus erlotinib. Primary objective of the safety run in part is to determine the MTD and the recommended Phase II dose of metformin combined with erlotinib as s | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives of the safety run in part are: • To assess the pharmacokinetics (PK) of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To explore antitumor activity of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To explore candidate markers or tumor characteristics predictive of antitumor activity Secondary objectives of the phase II part are: • To assess the anti-tumor activity, in terms of response rate, overall survival, QoL, of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To determine safety and tolerability of metformin and erlotinib when combined in subjects with NSCLCharboring wild-type EGFR gene. • To explore candidate markers or tumor characteristics predictive of antitumor activity ;Timepoint(s) of evaluation of this end point: 18 mounths | — |
Countries
Italy
Contacts
Public Contactfortunato ciardiello
department of experimental and clinical medicine "F. Magrassi"
Outcome results
None listed