Overview

Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Status:
Unknown status
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
Summary
Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang Cancer Hospital
Treatments:
Erlotinib Hydrochloride
Criteria
Inclusion Criteria:

- Histologically proven non-small cell lung cancer (squamous cell carcinoma,
adenocarcinoma, large cell carcinoma and etc)

- Tumor EGFR mutation

- Presence of measurable disease by RECIST

- stage IIIA or IIIB, non-resectable

- ECOG performance status 0-2

- No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy

- Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

- Carcinoid tumor, small cell carcinoma of lung

- Patients with any distant metastasis

- History of another malignancy except cured basal cell carcinoma of skin and cured
carcinoma in-situ of uterine cervix

- Any other morbidity or situation with contraindication for radiotherapy (e.g. active
infection, myocardial infarction preceding 6 months, symptomatic heart disease
including unstable angina, congestive heart failure or uncontrolled arrhythmias,
immunosuppressive treatment)

- Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days
before the first administration) and pregnant women

- Women and men of childbearing potential who have no willing of employing adequate
contraception

- Tumor EGFR wild