Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

Sponsor
Fudan University
Study ID
NCT02037997
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • docetaxel — DRUG
    docetaxel 75mg/m2 ivgtt D1
  • pemetrexed — DRUG
    pemetrexed 500mg/m2 ivgtt D1
  • Erlotinib — DRUG
    Erlotinib 150mg qd

Study Details

The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations

Key Dates

First listed
Jan 16, 2014
Start date
Dec 31, 2013
Status verified
Feb 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

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

Arms

  • Experimental: combination with Erlotinib
    Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
  • Active Comparator: sequential chemotherapy for Erlotinib
    docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

Central Contacts

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