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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 progressed non-squamous NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: Taiwan Chest Disease Association
• Treatments: Cisplatin; Docetaxel; Erlotinib Hydrochloride; Pemetrexed

Criteria

Inclusion Criteria:

1. Patients > 18 years, <75 years old

2. Pathological confirmation of non-squamous NSCLC

3. Clinical stage IIIB or IV

4. Measurable tumor size by RECIST criteria

5. ECOG <2

6. Adequate hematological laboratory parameters

7. Adequate hepatic, renal laboratory parameters

Exclusion Criteria:

1. Un-specified NSCLC

2. Prior therapy with any chemotherapy or EGFR TKI or monoclonal antibodies

3. Any unstable systemic disease (active infection, hypertension, unstable angina, CHF, liver cirrhosis, end stage renal failure etc., )

4. Nursing or pregnant mothers

5. Untreated Brain metastasis

6. ECOG>2