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Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma


Phase 4
18 Years
70 Years
Open (Enrolling)
Both
EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma

Thank you

Trial Information

Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma


This study is designed to compare the efficacy and safety of first-line icotinib treatment
and first-line chemotherapy followed by maintenance with icotinib.

Primary endpoint:

Progression-free survival between first-line icotinib treatment and first-line chemotherapy
followed by maintenance with icotinib

Secondary endpoint:

1. Overall survival between icotinib and chemotherapy

2. Time to Progression between icotinib and chemotherapy

3. Objective response rate and disease control rate between icotinib and chemotherapy


Inclusion Criteria:



- Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at
least one lesion that can be accurately measured in at least one dimension (longest
diameter to be recorded on CT); Patients must have previously untreated locally
advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR
activating mutation (exon 19 deletion, L858R).

Exclusion Criteria:

- Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that
target EGFR Patients must not be receiving any other investigational agents Any
evidence of interstitial lung disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Outcome Time Frame:

8 months

Safety Issue:

No

Principal Investigator

Jiao Shunchang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese People's Liberation Army (PLA) General Hospital

Authority:

China: Food and Drug Administration

Study ID:

BD-IC-IV08

NCT ID:

NCT01665417

Start Date:

August 2012

Completion Date:

February 2014

Related Keywords:

  • EGFR Positive Non-small Cell Lung Cancer
  • Adenocarcinoma
  • Icotinib
  • EGFR positive mutation
  • First-line treatment
  • Maintenance treatment
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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