Know Cancer

forgot password

Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC

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

Thank you

Trial Information

Phase II Trial of Neoadjuvant Concurrent Chemoradiation With Weekly Docetaxel/Cisplatin for Resectable IIIA-N2 NSCLC

Inclusion Criteria:

- Patients aged 18 years older.

- Present with histologically proven or cytological diagnosis of NSCLC Stage IIIA as
defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer,
that is amenable to surgery.

- No prior systemic chemotherapy or targeted therapy for lung cancer before screening.

- ECOG performance status of 0 or 1.

- Life expectancy ≥12 weeks.

- Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and
Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or
exceed this level).

- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal
(ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in
subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.

- Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60

- Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib,
gefitinib, cetuximab, trastuzumab).

- Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g.
monoclonal antibody therapy).

- History of another malignancy in the last 5 years with the exception of the
following:Other malignancies cured by surgery alone and having a continuous
disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the
skin and cured in situ carcinoma of the uterine cervix are permitted.

- Any unstable systemic disease (including active infection, uncontrolled hypertension,
unstable angina, congestive heart failure, myocardial infarction within the previous
year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic

- Known hypersensitivity to Tarceva or gemcitabine or cisplatin.

- Eye inflammation or eye infection not fully treated or conditions predisposing the
subject to this.

- Evidence of any other disease, neurological or metabolic dysfunction, physical
examination or laboratory finding giving reasonable suspicion of a disease or
condition that contraindicated the use of an investigational drug or puts the subject
at high risk for treatment-related complications.

Type of Study:


Study Design:

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

Outcome Measure:

downstage rate of mediastinal lymph nodes

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Jun Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University People's Hospital


China: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms