Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

Lilly

Status and phase: Terminated; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: pemetrexed; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259285

9901

H3E-XM-S092

Details and patient eligibility

About

To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of non-small-cell carcinoma of the lung
• Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon
• Tumour with possibility of curative surgery
• At least one uni-dimensionally measurable lesion
• Adequate pulmonary function to perform the planned surgical resection

Exclusion criteria

• Active infection (at the investigator's discretion)
• Pregnancy or breast-feeding
• Serious concomitant illness at the investigator's discretion
• Previous diagnosis of malignant disease
• They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A

Experimental group

Treatment:

Drug: pemetrexed

Drug: cisplatin