NCT02486354

Brief Summary

This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at below P25 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

June 28, 2015

Last Update Submit

June 28, 2015

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    6 months

Secondary Outcomes (3)

  • overall survival

    12 months

  • objective response rate

    2 months

  • number of patients suffered adverse events

    15 months

Study Arms (1)

icotinib

EXPERIMENTAL

Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.

Drug: icotinib

Interventions

icotinibDRUG

Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.

Also known as: Conmana
icotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer \[AJCC\] 6th edition of tumor-node-metastasis \[TNM\] staging system) NSCLC patients
  • Progressed after at least one platinum-based chemotherapy regimen at entry
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0
  • Adequate hematologic and biochemical values

You may not qualify if:

  • Patients with symptomatic brain metastases
  • Malignant tumor within the previous five years
  • Severe infection; congestive heart failure
  • Previous treatment with drugs targeting EGFR
  • History of interstitial lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Bejing Cancer Hospital

Beijing, Beijing Municipality, 100036, China

Location

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

Location

Beijing Chest Hospital

Beijing, Beijing Municipality, 101149, China

Location

Third Affiliated Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Sun yat-sen Univerisity Cancer Center

Guanzhou, Guangdong, 510060, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (2)

  • 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.

    PMID: 23948351RESULT

  • Hu X, Zhang L, Shi Y, Zhou C, Liu X, Wang D, Song Y, Li Q, Feng J, Qin S, Xv N, Zhou J, Zhang L, Hu C, Zhang S, Luo R, Wang J, Tan F, Wang Y, Ding L, Sun Y. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study. PLoS One. 2015 Nov 24;10(11):e0142500. doi: 10.1371/journal.pone.0142500. eCollection 2015.

    PMID: 26599904DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yan Sun, MD

    Cancer Hospital Chinese Academy of Medical Science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2015

First Posted

July 1, 2015

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

CN(10)