Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

A Phase III, Multi-center, Randomized Trial of Pemetrexed and Gefitinib in Never-smoker and Adenocarcinoma Patients With Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01066195

Enrollment

129

Registered

2010-02-10

Start date

2008-05-31

Completion date

Unknown

Last updated

2010-02-10

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

Conditions

Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer, Never-Smoker and Adenocarcinoma patients, Pemetrexed (ALIMTA), Gefitinib (IRESSA®)

Brief summary

Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female. The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.

Interventions

DRUGiressa

iressa 250mg per day every day

DRUGalimta

alimta 500mg/m2 every 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma 2. Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer 3. Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy) 4. Never smoker (less than 100 cigarette for the life time) 5. 18 year or older 6. ECOG 0-2 7. No history of biologic or immunotherapy 8. Tolerable renal function ( creatine clearance rate is 60ml/min or more) 9. Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)

Exclusion criteria

1. symptomatic brain metastasis 2. previously treated with EGFR tyrosine kinase inhibitor 3. previously treated with antifolate agents 4. poor oral absorption 5. patients with active infection 6. uncontrolled diabetes mellitus 7. significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure) 8. pregnant or nursing patients 9. history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma

Design outcomes

Primary

Measure	Time frame
progression-free survival	36 months

Secondary

Measure	Time frame
overall survival	36 months
objective response rate	36 months
toxicity	36 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026