Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Brief Title

Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Official Title

A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation

Brief Summary

      This phase II trial studies how well icotinib works in treating patients with completely
      resected stage IB NSCLC harboring EGFR mutation.
    

Detailed Description

      Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages
      IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor
      receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR
      mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group
      of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had
      non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to
      see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR
      mutation.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Disease-free survival

Secondary Outcome

 Overall survival

Condition

Lung Neoplasms

Intervention

Icotinib

Study Arms / Comparison Groups

 Intervention group

Description:  Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

128

Start Date

January 2015

Completion Date

December 2025

Primary Completion Date

December 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent provided.

          -  Males or females, Aged 18-75 years.

          -  Able to comply with the required protocol and follow-up procedures, and able to
             receive oral medications.

          -  Had completely resected pathological confirmed stage IIA-IIIA NSCLC.

          -  EGFR activating mutation in exon 19 or 21.

          -  Patient who can start the investigational therapy within 3-6 weeks after the complete
             resection.

          -  ECOG performance status of 0-1.

          -  Had a life expectancy of 12 weeks or more.

          -  Adequate hematological function, adequate liver function and renal function.

          -  Female patients, except those who are postmenopausal or surgically sterilized, must
             have a negative pre-study serum or urine pregnancy test.

        Exclusion Criteria:

          -  Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g.
             erlotinib, gefitinib, cetuximab, trastuzumab).

          -  Inability to comply with protocol or study procedures.

          -  Had a history another malignancy in the last 5 years with the exception of cured basal
             cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured
             epithelial carcinoma of the bladder.

          -  Any evidence confirmed tumor recurrence before investigational therapy.

          -  Known severe hypersensitivity to icotinib or any of the excipients of this product.

          -  Evidence of clinically active interstitial lung disease.

          -  Eye inflammation not fully controlled or conditions predisposing the subject to this.

          -  Any unstable systemic disease (including active infection, uncontrolled hypertension,
             unstable angina, congestive heart failure, myocardial infarction within the previous 6
             months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic
             disease).

          -  Known human immunodeficiency virus (HIV) infection.

          -  Pregnancy or breast-feeding women.

          -  Ingredients mixed with small cell lung cancer patients.

          -  History of neurologic or psychiatric disorders.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Si-Yu Wang, MD, +86 20 87343314, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT02264210

Organization ID

GASTO1003

Secondary IDs

wsy004

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

Si-Yu Wang, MD, Principal Investigator, Guangdong Province Association Study of Thoracic Oncology

Verification Date

July 2021