Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

NCT01744925 | Unknown Phase 2 DMC

• 1 other identifier: BD-IC-IV26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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.

  4 weeks

Secondary Outcomes (3)

• Progression free survival

  3 months

• Overall survival

  14 months

• Number of Participants with Adverse Events

  18 months

Study Arms (2)

Icotinib of routine dose

ACTIVE COMPARATOR

Icotinib: 125mg, oral administration, three times per day.

Drug: Icotinib of routine dose

Icotinib of high dose

EXPERIMENTAL

Icotinib: 375mg, oral administration, three times per day.

Drug: Icotinib of high dose

Interventions

Icotinib of routine dose DRUG

Icotinib: 125mg, oral administration, three times per day.

Also known as: Conmana, BPI-2009

Icotinib of routine dose

Icotinib of high dose DRUG

Icotinib: 375mg, oral administration, three times per day.

Also known as: BPI-2009, Conmana

Icotinib of high dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Changli Wang, M.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changli Wang, MD

CONTACT

86-022-23340123; wangchangli@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 7, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 7, 2017

Record last verified: 2012-08

Locations

CN (1)