Status:
COMPLETED
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
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Taiwan Chest Disease Association
Conditions:
Advanced Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To compare the differential influence of 1st line doublet chemotherapy containing Docetaxel versus Pemetrexed on clinical efficacy of Erlotinib as a second line therapy in patients with relapsed or pr...
Detailed Description
The clinical management of advanced non-small cell lung cancer (NSCLC) remains challenging. Initial therapies for advanced NSCLC with platinum-based regimens have shown consistent overall response rat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01204307
Start Date
January 1 2010
End Date
June 1 2015
Last Update
July 28 2015
Active Locations (4)
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1
Chang Gung Memorial Hospital
Taipei, Taipei, Taiwan, 10507
2
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, Taiwan
3
McKay Memorial Hospital
Taipei, Taiwan
4
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan