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

NCT02009605 | Unknown Phase 2 DMC

• 1 other identifier: ZYTOP 1401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of Lung

Keywords

icotinib, SCC

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

  3 months

Other Outcomes (1)

• Life quality

  14 months

Study Arms (1)

one arm

EXPERIMENTAL

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

Drug: Icotinib

Interventions

Icotinib DRUG

125mg, oral administration, three times per day.

Also known as: BPI-2009

one arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

79 Qingchun Road

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Interventions

icotinib

Study Officials

• Zhao Qiong, Dr.

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Yi Na, Dr.

CONTACT

tango654321@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 12, 2013
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

CN (1)