NCT01929200

Brief Summary

This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

August 21, 2013

Last Update Submit

May 21, 2015

Conditions

Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival

    6 months

Secondary Outcomes (1)

  • Overall survival

    6 months

Study Arms (2)

1-year treatment with icotinib

EXPERIMENTAL

Patients will receive 1-year treatment with icotinib after operation.

Drug: 1-year treatment with icotinib

2-year treatment with icotinib

EXPERIMENTAL

Patients will receive 2-year treatment with icotinib after operation.

Drug: 2-year treatment with icotinib

Interventions

1-year treatment with icotinibDRUG

Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.

Also known as: Commana, BPI-2009
1-year treatment with icotinib
2-year treatment with icotinibDRUG

Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.

Also known as: Commana, BPI-2009
2-year treatment with icotinib

Eligibility Criteria

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

You may qualify if:

  • The patients signed the written informed consent
  • The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
  • The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
  • The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

You may not qualify if:

  • Patients with unresected tumor
  • Wild EGFR type
  • Allergic to the study drug
  • Patients have severe non-cancerous diseases
  • Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer hospital

Beijing, 100142, China

RECRUITING

Related Publications (2)

  • Lv C, Ma Y, Feng Q, Fang F, Bai H, Zhao B, Yan S, Wu N, Zheng Q, Li S, Chen J, Wang J, Feng Y, Wang Y, Pei Y, Fang J, Yang Y. A pilot study: sequential gemcitabine/cisplatin and icotinib as induction therapy for stage IIB to IIIA non-small-cell lung adenocarcinoma. World J Surg Oncol. 2013 Apr 26;11:96. doi: 10.1186/1477-7819-11-96.

    PMID: 23621919BACKGROUND

  • Lv C, Wang R, Li S, Yan S, Wang Y, Chen J, Wang L, Liu Y, Guo Z, Wang J, Pei Y, Yu L, Wu N, Lu F, Gao F, Chen J, Liu Y, Wang X, Li S, Han B, Zhang L, Ma Y, Ding L, Wang Y, Yuan X, Yang Y. Randomized phase II adjuvant trial to compare two treatment durations of icotinib (2 years versus 1 year) for stage II-IIIA EGFR-positive lung adenocarcinoma patients (ICOMPARE study). ESMO Open. 2023 Aug;8(4):101565. doi: 10.1016/j.esmoop.2023.101565. Epub 2023 Jun 20.

    PMID: 37348348DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Therapeuticsicotinib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yue Yang, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Yang, MD

CONTACT

86-10-88196568zlyangyue@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 27, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

August 1, 2017

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

CN(1)