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Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01783834
Enrollment
95
Registered
2013-02-05
Start date
2008-02-29
Completion date
2014-06-30
Last updated
2016-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previous Treated Metastatic Non-small Cell Lung Cancer

Keywords

Pemetrexed, Gefitinib, iressa, alimta

Brief summary

To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer

Interventions

DRUGGefitinib

compare progression free survivla rate and safety to both drugs

DRUGPemetrexed

compare PFS rate, safety to both drugs

Sponsors

Gachon University Gil Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients * second line * ECOG 0~2 * Patients with normal liver function and renal function

Exclusion criteria

* Patients with severe acute infection requiring antibiotic therapy * Patients who have received treatment in other areas of cancer within 5 years * During pregnancy and lactation patients

Design outcomes

Primary

MeasureTime frame
Overall response rate5 years

Secondary

MeasureTime frame
Progression free survival5years

Other

MeasureTime frame
Number of participants with adverse events5years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026