Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

Plain-language summary

This study looks at induction (pre-surgery) erlotinib therapy compared with gemcitabine/carboplatin chemotherapy in patients with stage IIIA-N2 non-small cell lung cancer. People who were suitable for surgery, had not received prior therapy and had enough tissue for gene analysis could take part. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Guangdong Provincial People's Hospital

Intervention

neoadjuvant erlotinib therapy, neoadjuvant gemcitabine/carboplatin therapy

Start date

9/1/2007

Estimated completion

6/1/2013

Countries

China

Related genes

Locations

• Guangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Written informed consent
* Histological or cytological documented
* Resectable NSCLC of stage IIIA-N2 confirmed by mediastinoscopy or PET
* Naive therapy NSCLC
* Candidates should be tolerated with induction therapy and thoracotomy with ECOG performance status 0-2, adequate haematological and Hepatic- renal function and qualified lung function
* Enough tissue samples to perform gene analysis

Exclusion Criteria:

* Small cell lung cancer
* Pregnant or breast-feeding women
* Any unstable systemic disease
* Patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial