Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease

December 26, 2014 updated by: Betta Pharmaceuticals Co., Ltd.

An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease

The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Hospital for Chest Tumors & Tuberculosis Diseases
        • Contact:
          • Chen Qun, M.D.
          • Phone Number: 0086-13860669883
        • Principal Investigator:
          • Chen Qun, M.D.
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincal Hospital
        • Contact:
          • Cui Tongjian, M.D.
          • Phone Number: 0086-13905920326
        • Principal Investigator:
          • Cui Tongjian, M.D.
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincal Cancer Hospital
        • Contact:
          • Huang Cheng, M.D.
          • Phone Number: 0086-13905010397
        • Principal Investigator:
          • Huang Cheng, M.D.
      • Xiamen, Fujian, China, 361024
        • Recruiting
        • The second hospital of Xiamen City
        • Contact:
          • Ke Mingyao, M.D.
          • Phone Number: 0086-13860166866
        • Principal Investigator:
          • Ke Mingyao, M.D.
    • Hunan
      • Changsha, Hunan, China, 410006
        • Recruiting
        • Hunan Provincal Cancer Hospital
        • Contact:
          • Wu Lin, M.D.
          • Phone Number: 0086-13706671349
        • Principal Investigator:
          • Wu Lin, M.D.
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • The Second People's Hospital of Sichuan
        • Contact:
          • Yu Jingrui, M.D.
          • Phone Number: 0086-13551237583
        • Principal Investigator:
          • Yu Jingrui, M.D.
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Lu Li Qin, M.D.
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Zhang Yi Ping, M.D.
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
        • Principal Investigator:
          • Pan Minghong, M.D.
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine
        • Contact:
        • Principal Investigator:
          • Huang Jianjin, M.D.
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital of Medical School of Zhejiang University
        • Contact:
          • Zhou Jianying, M.D.
          • Phone Number: 0086-13750881678
          • Email: drzjy@163.com
        • Principal Investigator:
          • Zhou Jianying, M.D.
      • Hangzhou, Zhejiang, China, 310006
        • Active, not recruiting
        • Zhejiang Traditional Chinese Medical Hospital
      • Hangzhou, Zhejiang, China, 310007
        • Active, not recruiting
        • Zhejiang Hospital
      • Ningbo, Zhejiang, China, 315040
        • Recruiting
        • Yinzhou People's Hospital
        • Contact:
          • Guo Jianxin, M.D.
          • Phone Number: 0086-13605741696
        • Principal Investigator:
          • Guo Jianxin, M.D.
      • Ningbo, Zhejiang, China, 315046
        • Recruiting
        • Ningbo Medical Treatment Center Lihuili Hospital
        • Contact:
          • Shen Weiyu, M.D.
          • Phone Number: 0086-13805876129
        • Principal Investigator:
          • Shen Weiyu, M.D.
      • Taizhou, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Hu Wei, M.D.
          • Phone Number: 0086-13606657129
        • Principal Investigator:
          • Hu Wei, M.D.
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical College
        • Contact:
          • Li Wenfeng, M.D.
          • Phone Number: 0086-13968840592
        • Principal Investigator:
          • Li Wenfeng, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
  • No previous targeted treatment such as gefitinib, erlotinib.
  • With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) at least according to RECIST Criteria
  • WHO performance status(PS)<= 2
  • N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
  • Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

  • Allergic to icotinib
  • Patients with metastatic brain tumors with symptoms.
  • Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Icotinib of Routine Dose
Oral Drug icotinib 125 mg three times per day
Drug: Icotinib of routine dose
Icotinib of routine dose: 125 mg is administered orally three times per day.
Other Names:
  • BPI-2009
  • Icotinib
  • Comana
Experimental: Icotinib of High Dose
Oral Drug icotinib 250 mg three times per day
Drug: Icotinib of high dose
Icotinib: 250 mg is administered orally three times per day.
Other Names:
  • BPI-2009
  • Icotinib
  • Comana

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 6 months
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 15 months
Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
15 months
Transformation rate from stable disease to complete response or partial response
Time Frame: 6 weeks
Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
6 weeks
Incidence rate of adverse events
Time Frame: 40 months
Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication.
40 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Betta Pharmaceuticals Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhang Yi Ping, M.D., Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BD-IV-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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