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Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Non-small-cell Lung Cancer

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Trial Information

Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation


Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung
cancer whose primary tumors are too large to allow for surgery. Reduction in size of the
primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover,
the goals have expanded to include: determination of the sensitivity of the tumor so that
subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong
survival.


Inclusion Criteria:



- 1.The patients signed the written informed consent. 2.The patients present with
operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.

3.The patients have no history of anti-cancer therapies including chemotherapy,
radiation therapy, and surgical therapy.

4.The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1. 5.The age of
patient is ≥ 18 years old with a life expectancy longer than 3 months.

Exclusion Criteria:

- 1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug.
4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current
administration of anti-cancer therapies, or are attending some other clinical trials.

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:

Objective response rate

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Weimin Mao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

CFDA: China Food and Drug Administration

Study ID:

BD-IC-IV06

NCT ID:

NCT01843647

Start Date:

April 2013

Completion Date:

February 2017

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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