A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Sponsor
Chinese PLA General Hospital
Study ID
NCT01131429
Phase
PHASE2
Status
Unknown

Conditions

  • Carcinoma, Non-Small Cell Lung
  • Drug Therapy
  • Genes, EGFR
  • Neoplasms, Lung

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib 150 mg/d per os until proven disease progression
  • Docetaxel — DRUG
    Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
  • Cisplatin — DRUG
    cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
  • Docetaxel — DRUG
    Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
  • Cisplatin — DRUG
    Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
  • Erlotinib — DRUG
    Erlotinib 150 mg/d per os as second-line treatment

Study Details

Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .

Key Dates

First listed
May 27, 2010
Start date
Jun 30, 2010
Status verified
Apr 2010
Primary completion
Jun 30, 2013
Completion
Jun 30, 2015

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: first-line erlotinib
    erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment
  • Active Comparator: second-line erlotinib
    docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment

Primary Outcome Measure

Overall survival [ Time Frame: three year ]

Central Contacts

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