Title
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study
Phase
Phase 2Lead Sponsor
University of CopenhagenStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Non-small Cell Lung CancerIntervention/Treatment
erlotinib ...Study Participants
15The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).
Tarceva 150 mg/day
66 Gy/33 F/5 F per week for 5 weeks
Inclusion Criteria: Age ≥18 years Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion Performance status ≤2 on the ECOG scale Serum bilirubin must be ≤1.5 upper limit of normal (ULN) ALAT ≤2 x ULN Able to comply with study and follow-up procedures Patients with reproductive potential must use effective contraception Written (signed) informed consent to participate in the study Exclusion Criteria: Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease) Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer) Inability to take oral medication, or requirement of intravenous alimentation Nursing mothers
| Event Type | Organ System | Event Term | Concurrent Tarceva and RT in LA-NSCLC |
|---|
Progression free survival from registration according to RECIST 1.1
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