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An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR


Inclusion Criteria:



- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with
Histologic or cytologic confirmation.

- Wild type epidermal growth factor receptor status.

- Progressed after first-line chemotherapy.

- No previous systemic anticancer therapy.

- Measurable lesion according to response evaluation criteria in solid tumors with at
least one measurable lesion not previously irradiated.

- Provision of written informed consent.

Exclusion Criteria:

- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic,
stable, radiographic changes who are asymptomatic need not be excluded).

- Positive epidermal growth factor receptor mutation.

- Known severe hypersensitivity to icotinib or any of the excipients of this product.

- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the study.

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 Description:

Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Changli Wang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital

Authority:

China: Food and Drug Administration

Study ID:

BD-IC-IV26

NCT ID:

NCT01744925

Start Date:

October 2012

Completion Date:

May 2014

Related Keywords:

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

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