To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Pemetrexed 500 mg/m2; Drug: Pemetrexed 1000 mg/m2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191191

H3E-JE-NS01 (Other Identifier)

5250

Details and patient eligibility

About

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).

Enrollment: 226 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical stage III or IV
• Previously treated with one or two chemotherapeutic regimens
• Performance status: 0-2

Exclusion criteria

• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Pemetrexed 500 mg/m2

Experimental group

Description:

Pemetrexed 500 mg/m2

Treatment:

Drug: Pemetrexed 500 mg/m2

Pemetrexed 1000 mg/m2

Experimental group

Description:

Pemetrexed 1000 mg/m2

Treatment:

Drug: Pemetrexed 1000 mg/m2