Locally advanced or metastatic Non Small Cell Lung Cancer MedDRA version: 14.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Tarceva 25mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ERLOTINIB
CAS Number: 183321-74-6
Current Sponsor code: Ro 50-8231
Other descriptive name: erlotinib hydrochloride
Sponsors
Roche Products Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnostic phase: 1. Patients able and willing to give written informed consent. Consent must be obtained prior to any study-specific procedure 2. Male or female patients aged 18 years. 3. ECOG Performance Status 0-3 4. Histologically confirmed or working diagnosis (on clinical grounds) of locally advanced (stage TuB with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) NSCLC 5. Patients with Non-squamous or Squamous advanced NSCLC are to be screened in the diagnostic phase of the study 6. Ability to provide adequate biopsy sample for EGFR mutation testing Treatment phase: 1. Patients must have been proven to have a histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study. 2. Adequate haematological function:- - Haemoglobin =9 g/dL - Absolute neutrophil count (ANC) =1.5 × 109/L - Platelets =100 × 109/L - APTT in the normal range (1.2 × DLN-1.2 × ULN) 3. Adequate liver function: - Aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 × ULN in the absence of liver metastases (AST, ALT =5 × ULN in case of liver metastases) - Total bilirubin =1.5 × ULN - INR =1.5 4. Adequate renal function as assessed by the investigator - Creatinine =1.5 × ULN 5. Able and willing to comply with the required protocol and follow-up procedures including answering the QoL questionnaire, and able to receive oral medications 6. Female patients must be postmenopausal (12 months of amenorrhea), surgically sterile or they must agree to use a physical method of contraception. Male patients must be surgically sterile or agree to use a barrier method of contraception. Women with an intact uterus (unless amenorrhoeic for the last 12 months) must have a negative pregnancy test (urine or serum) within 3 days prior to enrolment into the study. Male and female patients must use effective contraception during the study and for a period of 2 weeks following the last administration of erlotinib 7. Patients with asymptomatic and stable (as defined by centre standard) cerebral metastases receiving medical treatment will be eligible for the study. Patients who have received radiation therapy for their cerebral metastases before the initiation of systemic treatment for non-small-cell lung cancer also will be eligible. Radiotherapy can be given but should be completed prior to the initiation of study therapy – a 2 week ‘washout’ period is recommended 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will be excluded if the answer to any of the following statements is "yes". Treatment phase: 1. Previous treatment for NSCLC with chemotherapy (except for neo-adjuvant or adjuvant chemotherapy completed >6 months prior to consent for diagnostic phase of the study) or therapy against EGFR, either with antibody or small molecule (tyrosine kinase inhibitor). NB: Patients can have received radiotherapy as long as the irradiated lesion is not the only target lesion for evaluating response and as long as radiotherapy has been completed before initiating the study treatment (a 2-week period is recommended). 2. Treatment with any investigational drug agent during the 3 weeks before enrollment in the study 3. Patients with symptomatic cerebral metastases 4. Known hypersensitivity to erlotinib or any of its excipients 5. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications 6. Positive urine or serum pregnancy test in women of childbearing potential. Patients (male or female) with reproductive potential not willing to use effective method of contraception. Female patients should not be pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the prevalence of EGFR exon 19 deletion or exon 21 mutation in NSCLC patients tested in the UK.;Secondary Objective: • Quality of life (QoL) • Response rate • Progression free survival (PFS) • Safety ;Primary end point(s): The diagnostic phase will end when approximately 1200 patients have been tested for EGFR mutations. The treatment phase will end when all eligible patients have experienced progressive disease, death, unacceptable toxicities or withdrawn consent. ;Timepoint(s) of evaluation of this end point: When 1200 patients have been tested for EGFR mutations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are Quality of Life, Response Rate, Progressive Disease and Safety (treatment phase).;Timepoint(s) of evaluation of this end point: The treatment phase is event driven and will end when all eligible patients have experienced progressive disease, death, unacceptable toxicities or withdraws consent. | — |
Countries
United Kingdom
Contacts
Public ContactTarceva Medical Manager-Asud Khaliq
Roche Products Limited
Outcome results
None listed