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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01066195
• Other study ID #: 2008-04-030
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: February 8, 2010
• Last updated: February 9, 2010
• Start date: May 2008

Study information

• Verified date: February 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 129
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• iressa
iressa 250mg per day every day
• alimta
alimta 500mg/m2 every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		36 months	No
Secondary	overall survival		36 months	No
Secondary	objective response rate		36 months	No
Secondary	toxicity		36 months	Yes