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NCT Number: NCT02044328

Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma 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 ≤ 0-1
  • The patients signed the written informed consent

Exclusion criteria

  • 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

Treatment and study plan

Icotinib

Drug

Icotinib is administered 125 mg three times per day.

Other names: Commana, BPI-2009

Primary outcomes

  1. Disease-free survival

    Time frame: 2 years

Secondary outcomes

  1. 1-year Survival Rates

    Time frame: 1 year

  2. 3-year Survival Rates

    Time frame: 3 years

  3. Number of patients suffered adverse events

    Time frame: 42 months

    Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0

Other outcomes

  1. Difference of disease-free survival by status of Bcl-2 interacting mediator of cell death

    Time frame: 2 years

    Compare the disease-free survival between patients with positive Bcl-2 interacting mediator of cell death mutation and patients without this mutation.

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study

Acronym: ICAPE

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Jan 23, 2014
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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