Influence of Prior Chemotherapy on Clinical Benefit With Erlotinib in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With or Without EGFR Gene Mutation
Advanced Non-Squamous Non-Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Advanced Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients > 18 years, <75 years old
- Pathological confirmation of non-squamous NSCLC
- Clinical stage IIIB or IV
- Measurable tumor size by RECIST criteria
- ECOG <2
- Adequate hematological laboratory parameters
- Adequate hepatic, renal laboratory parameters
Exclusion Criteria:
- Un-specified NSCLC
- Prior therapy with any chemotherapy or EGFR TKI or monoclonal antibodies
- Any unstable systemic disease (active infection, hypertension, unstable angina, CHF, liver cirrhosis, end stage renal failure etc., )
- Nursing or pregnant mothers
- Untreated Brain metastasis
- ECOG>2
Sites / Locations
- Chang Gung Memorial Hospital, Kaohsiung Branch
- Chang Gung Memorial Hospital
- McKay Memorial Hospital
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
docetaxel/cisplatin
Pemetrexed/cisplatin
The treatment schedule comprises a maximum of six 3-week treatment cycles consisting of weekly docetaxel (30 mg/m2) and cisplatin (37.5 mg/m2) for 2 consecutive weeks followed by a 1-week treatment-free period. The patients will be assessed after each cycle and a final assessment will be done after three and six cycles.
The patients are given pemetrexed (500 mg/m2 as a 10-min intravenous infusion) and cisplatin (75 mg/m2) on day 1 every 21 days. Dexamethasone (4 mg) is administered twice daily on the day before, the day of, and the day after each dose of pemetrexed. Oral folic acid supplementation (1000 mg) is administered daily, beginning approximately 2 weeks prior to the first dose of pemetrexed and continues until 3 weeks after treatment discontinuation. A 1000 mg vitamin B12 injection is administered intramuscularly approximately 1-2 weeks before the first dose of pemetrexed and is repeated approximately every 9 weeks until 3 weeks after therapy discontinuation.