Unresectable non-small cell lung cancer with EGFR mutations (non-squamous histology)
Conditions
Interventions
Chemotherapy (Carboplatin + Pemetrexed)
Sponsors
Hokkaido Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven NSCLC (non-squamous histology) 2) Chemotherapy-naive patients 3) Relapsed NSCLC without adjuvant chemotherapy is also eligible 4) Stage IIIB, IV NSCLC 5) At least one measurable lesion 6) Over 20 years old and under 75 years old 7) ECOG performance status of 0-1 8) Adequate organ functions (WBC >= 4,000 /mm3, Neutrophil >= 2,000 /mm3, Platelet >= 100,000 /mm3, Hemoglobin concentration >= 9.0 g/dl, AST or ALT <= 100 (<= 150 case with liver mets), T-bilirubin <= 1.5 mg/dl, Cr <= 1.2 mg/dl, creatinin clearance >= 60 ml/min, PaO2 or SpO2 >= 60 Torr or 95%) 9) Life expectancy of at least 12 weeks 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active infection 2) fever >= 38C 3) Severe and uncontrolled complication 4) Other active malignancies 5) Unstable metastases to the brain 6) Uncontrolled pleural, pericardial effusion or ascites 7) Presence of active interstitial pneumonia 8) Allergy to treatment drugs 9) Pregnant patients 10) Unstable psychic disorder 11) Continuous use of steroid 12) Decision of ineligibility by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, overall survival, and progression-free survival | — |
Countries
Japan
Outcome results
None listed