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A phase II study of carboplatin plus pemetrexed followed by gefitinib for stage IIIB/IV non-small cell lung cancer with EGFR mutation

A phase II study of carboplatin plus pemetrexed followed by gefitinib for stage IIIB/IV non-small cell lung cancer with EGFR mutation - carboplatin, pemetrexed and gefitinib for lung cancer with EGFR mutation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003354
Enrollment
60
Registered
2010-03-23
Start date
2010-03-01
Completion date
Unknown
Last updated
2026-06-29

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 with EGFR mutation

Interventions

carboplatin, pemetrexed, gefitinib

Sponsors

Kanagawa Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with histologically or cytologically confirmed NSCLC with EGFR mutation, clinical stage IIIB or IV, an expected survival of at least 12 weeks, age >20 years and < 75 years, Eastern Cooperative Oncology Group PS score 0-1, leukocyte count>=4,000/mm2, hemoglobin >=10 g/dl, platelet count >=100,000/mm2, total serum bilirubin <=1.5 mg/dl, aspartate aminotransferase and alanine aminotransferase <100 IU/L, serum creatinine <=1.5 mg/dl. Patients who had experienced postoperative recurrence were eligible, written informed consent was obtained from every patient.

Exclusion criteria

Exclusion criteria: Patients who had received chemotherapy or radiotherapy were excluded. Patients who have massive pleural effusion or pericardial effusion, who have uncontrolled cardiac disease, diabetes mellitus or hypertension, who have infectious disease, who have interstitial pneumonitis, were excluded.

Design outcomes

Primary

MeasureTime frame
2-year survival rate

Secondary

MeasureTime frame
overall survival, progression-free survival, anti-tumor effect, toxicity

Countries

Japan

Contacts

Public ContactFumihiro Oshita

Kanagawa Prefectual Ashigarakami Hospital Comprehensive Medical Care

foshita@ashigarakami-hospital.jp+81-465-83-0351

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026