Icotinib in Previously Treated Non/Light-smoking Patients With Advanced Squamous Cell Lung Cancer

An Open-label, Single-armed Pilot Study to Evaluate the Efficacy of Icotinib in Previously Treated Non/Light-smoking Patients With Squamous Lung Cancer

This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer.

Study Overview

• Status: Unknown
• Conditions: Squamous Cell Carcinoma of Lung
• Intervention / Treatment: Drug: Icotinib

Detailed Description

This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • 79 Qingchun Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic or recurrent squamous cell lung cancer from the primary lesion and/or lymph nodes, stage IIIB or IV patients with non-smoking or light-smoking history.
• Failure of at least 1, and no more than 2, prior chemotherapy regimens for advanced disease (either due to progressive disease or toxicity).
• Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan.
• Be >= 18 years of age.
• Expected survival period over 12 weeks;
• ECOG PS 0-2. Adequate organ system function as defined within the protocol.
• Patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable.
• Consent compliance research plan and follow-up process, and be able to carry out oral therapy; Provision of written informed consent.
• In women of childbearing age, must be in before starting treatment within 7 day of urine pregnancy test and the result is negative, and not in the lactation period, and reproductive age men and women prior to entry into the study, the research process until 90 days after stopping all agree to use reliable methods of contraception;
• Weight loss =< 10% in past 6 months.
• Adequate tumor tissue for detection of molecular biomarkers.

Exclusion Criteria:

• Patients who have previously received treatment with EGFR-TKIs.
• Concomitant treatment with any other experimental drug under investigation or anti-tumor therapy;
• Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery.
• Known severe hypersensitivity to icotinib or any of the excipients of this product.
• Presence of uncontrolled pleural effusion or/and peritoneal effusion;
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
• Past or current history of neoplasm (other than the entry diagnosis) in past 5 years, with the exception of treated basal cell carcinoma or carcinoma in situ of the cervix, or other cancers cured by local therapy alone.
• Women who are lactating.or have positive pregnancy test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one arm; Icotinib of routine dose Icotinib: 125mg, oral administration, three times per day.	Drug: Icotinib; 125mg, oral administration, three times per day.; Other Names: BPI-2009

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Progression free survival 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.	3 months
Overall survival	Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.	14 months
Number of Participants with Adverse Events	Adverse events, serious adverse events, incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.	3 months

Other Outcome Measures

Outcome Measure	Time Frame
Life quality	14 months

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Principal Investigator: Zhao Qiong, Dr., Zhejiang University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: December 8, 2013
• First Submitted That Met QC Criteria: December 8, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: icotinib, SCC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ZYTOP 1401