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Clinical Trial Details — Status: Temporarily not available

Administrative data

NCT number NCT01297101
Other study ID # ML25268(C-TONG1101)
Secondary ID
Status Temporarily not available
Phase N/A
First received February 15, 2011
Last updated February 15, 2011

Study information

Verified date January 2011
Source Shanghai Chest Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

The aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.


Description:

Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those patients.

Tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy.

Based on the encouraging results reported from the SLCG phase II study reported the efficacy of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would prolong overall survival, delay disease progression and be well tolerated, mOS reached 27 months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo, Tarceva may provide an important treatment alternative for local advanced pts with EGFR mutation.


Recruitment information / eligibility

Status Temporarily not available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pathologically diagnosed of non-small cell lung cancer

- Diagnosed as stage IIIA-NI, N2, except for T4N1M0

- The diagnosis standard of N1 or N2 is as below:

- The short axis of N1 lymph node of Stage IIIA-N1 must be = 10 mm on Computed Tomography, and the Standard Uptake Value (SUV) on PET-CT of N1 lymph node must be > 2.5

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)

- Resection of primary malignancy

Study Design

N/A


Intervention

Drug:
Erlotinib
150mg/qd, on day 15-28 of each 28 day cycle.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Shanghai Chest Hospital Guangdong General Hospital, Shanghai Pulmonary Hospital, Shanghai, China
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