Study of Chemotherapy Sequenced by or Combined With EGFR-TKIs for NSCLC Patients Failed to EGFR-TKIs Therapy

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

There are two different treatment modes for NSCLC patients who failed to epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI. One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two different treatment modes.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Docetaxel; Gefitinib; Pemetrexed

Criteria

Inclusion Criteria:

• age ≥ 18 years

• histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable)

• clinical stages ⅢB or Ⅳ

• recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy

• partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment

• at least one bidimensionally measurable or radiographically assessable lesion

• Eastern cooperative oncology group performance status (ECOG PS) ≤ 2

• life expectancy ≥ 12 weeks

• adequate hematological, renal, and hepatic functions

Exclusion Criteria:

• additional malignancies

• uncontrolled systemic disease

• any evidence of clinically active interstitial lung disease

• newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery

• pregnancy or breast feeding phase