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

Sponsor
China Medical University, China
Study ID
NCT03123484
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 21, 2017
Start date
Apr 30, 2017
Status verified
Apr 2017
Primary completion
Apr 30, 2019
Completion
Oct 31, 2019

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: β-elemene+EGFR TKI
    EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) and β-elemene
  • Active Comparator: EGFR TKI
    EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)

Primary Outcome Measure

PFS ratio in 12 week [ Time Frame: 12 week ]

Central Contacts

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