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Non-small Cell Lung CancerPhase 3ICOGENNCT01040780

Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients

A Phase 3 study testing Icotinib and Gefitinib in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 27 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Icotinib and Gefitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
27 sitesChina
Study dates
Feb 2009to Dec 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).
  • Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior chemotherapy must be completed at least 4 weeks before study enrollment; =.

Who cannot join

  • 1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality, 100020

  • Cancer Hospital, Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Bejing Cancer Hospital

    Beijing, Beijing Municipality, 100036

  • 307 Hospital of PLA

    Beijing, Beijing Municipality, 100071

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100079

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 101149

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • the Second Xiangya Hospital，Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Third Affiliated Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • Guanghzou General Hospital of PLA

    Guangzhou, Guangdong, 510000

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital， Southern Medical University

    Guangzhou, Guangdong, 510515

  • Sun yat-sen Univerisity Cancer Center

    Guanzhou, Guangdong, 510060

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310022

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • 81 Hospital of PLA

    Nanjing, Jiangsu, 210002

  • Nanjing General Hospital of Nanjing Command，PLA

    Nanjing, Jiangsu, 210002

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Ruijin Hospital，Shanghai Jiao-Tong University

    Shanghai, Shanghai Municipality, 200023

  • Zhongshan Hospital，Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Changhai Hospital， Second Military Medical University

    Shanghai, Shanghai Municipality, 200433

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Tangdu Hospital, Fourth Military Medical University

    Xi’an, Shanxi, 710000

  • Xijing Hospital, Fourth Military Medical University

    Xi’an, Shanxi, 710032

Other trials in China

About this study

Official title: A Randomized,Double-blind,Multicenter Phase III Trial to Evaluate the Safety and Efficacy of Icotinib and Gefitinib in Advanced NSCLC Patients Previously Treated With Chemotherapy

The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.

Read the detailed description

Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.

Being tested
Icotinib, Gefitinib
Keywords
Efficacy, Safety, EGFR-TKI, phase III, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IcotinibDrug

    Also called BPI-2009, Conmana

    125 mg three times daily (375 mg per day) by mouth

  • GefitinibDrug

    Also called ZD1839, Iressa

    250 mg every 24 hours by mouth

Study groups in NCT01040780
Study groupRoleWhat they receive
IcotinibExperimental125 mg three times daily (375 mg per day) by mouth
Receives: Drug: Icotinib
GefitinibActive comparator250 mg every 24 hours by mouth
Receives: Drug: Gefitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

    Measured: 2-7 months

Secondary outcomes (4)

  1. Overall Survival

    Median number of months from first study treatment until time of death

    Measured: From first study treatment until time of death

  2. Best Tumor Response

    Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline

    Measured: While receiving study treatment; assessed every 21 days until progression

  3. Time To Progression

    Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.

    Measured: 2-7 months

  4. Safety and Tolerability

    Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.

    Grade 3 = Severe Grade 4 = Life-threatening or disabling

    Measured: Assessed over two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMar 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01040780
Sponsor's protocol ID
BPI-2009
Acronym
ICOGEN
Status last verified
Jan 2014
First submitted
27 Dec 2009
Last updated
14 Feb 2014
Data monitoring committee
Yes

Publications

  • Camidge DR. Icotinib: kick-starting the Chinese anticancer drug industry. Lancet Oncol. 2013 Sep;14(10):913-4. doi: 10.1016/S1470-2045(13)70385-1. Epub 2013 Aug 13. No abstract available.

    PubMed 23948350

  • Zhao Q, Shentu J, Xu N, Zhou J, Yang G, Yao Y, Tan F, Liu D, Wang Y, Zhou J. Phase I study of icotinib hydrochloride (BPI-2009H), an oral EGFR tyrosine kinase inhibitor, in patients with advanced NSCLC and other solid tumors. Lung Cancer. 2011 Aug;73(2):195-202. doi: 10.1016/j.lungcan.2010.11.007. Epub 2010 Dec 8.

    PubMed 21144613

  • Shi Y, Zhang L, Liu X, Zhou C, Zhang L, Zhang S, Wang D, Li Q, Qin S, Hu C, Zhang Y, Chen J, Cheng Y, Feng J, Zhang H, Song Y, Wu YL, Xu N, Zhou J, Luo R, Bai C, Jin Y, Liu W, Wei Z, Tan F, Wang Y, Ding L, Dai H, Jiao S, Wang J, Liang L, Zhang W, Sun Y. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial. Lancet Oncol. 2013 Sep;14(10):953-61. doi: 10.1016/S1470-2045(13)70355-3. Epub 2013 Aug 13.

    PubMed 23948351

  • Tan F, Shen X, Wang D, Xie G, Zhang X, Ding L, Hu Y, He W, Wang Y, Wang Y. Icotinib (BPI-2009H), a novel EGFR tyrosine kinase inhibitor, displays potent efficacy in preclinical studies. Lung Cancer. 2012 May;76(2):177-82. doi: 10.1016/j.lungcan.2011.10.023. Epub 2011 Nov 22.

    PubMed 22112293

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Icotinib and Gefitinib in people with Non-small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 27 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 2-7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01040780, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.

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