A study to assess the incidence of mutations in the tyrosine kinase domain of the epidermal growth factor receptor in UK patients with newly diagnosed locally advanced or metastatic non-small cell lung cancer and to investigate the quality of life of these patients undergoing first-line monotherapy with erlotinib (Tarceva®). - TRANSCRiPT

Roche Products Limited0 sites1,200 target enrollmentOctober 8, 2010

Overview

No summary available.

Registry

who.int

Start Date

October 8, 2010

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:\-

•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.