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

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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)

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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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