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A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

A Phase II Study of Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer

Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation
therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by
Erlotinib 150 mg/day consolidation treatment.

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

- Tumor EGFR wild

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)

Outcome Time Frame:

After the thoracic radiotherapy and concurrent Erlotinib treatment

Safety Issue:


Principal Investigator

Shenglin Ma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital


China: Ethics Committee

Study ID:




Start Date:

January 2010

Completion Date:

March 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Erlotinib
  • Radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms