NCT03123484

β-elemene Combine With EGFR-TKI for Advanced EGFR-TKI-resistant NSCLC

β-elemene Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Epidermal Growth Factor Receptor tyrosine-kinase inhibitors （EGFR-TKIs）, including gefitinib，erlotinib and icotinib demonstrate excellent effect on the treatment of non small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. In this study, the investigators aim to explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung cancer with EGFR-TKI resistance.

Detailed description

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), including gefitinib，erlotinib and icotinib demonstrate excellent effect on the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. Beta-elemene, a natural plant drug extracted from Curcuma wenyujin, has been used as an antitumor drug for different tumors, including NSCLC via mechanism that inhibits Ras/Mapk signaling and cell cycle progression.In this study, the investigators aim to explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung cancer with EGFR-TKI resistance. main objectives: progression-free survival (PFS) ratio in 12 week the secondary goal: Objective Response Rate （ORR）

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	β-elemene	β-elemene：400-600mg + 5%GS 500ml,ivgtt,qd, continuously 45days
DRUG	EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)	EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) as usual

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-04-01
• Completion: 2019-10-01
• First posted: 2017-04-21
• Last updated: 2017-04-21