Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell-Lung Cancer

Treatments: Drug: cisplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191763

B9E-VI-S314

7138

Details and patient eligibility

About

Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• define histologic or cytologic diagnosis of non small cell lung cancer.
• determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer.
• define performance status of 0-1 on ECOG scale
• do not have any prior tumor therapy
• to be suitable for curative resection

Exclusion criteria

• to have any treatment within the last 30 days with any investigational drug.
• to get concurrent administration of any other tumor therapy
• to be pregnant
• to have poorly controlled diabetes mellitus
• to have serious concomitant disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)