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

NCT02044328 | Completed Phase 2 DMC

• 1 other identifier: BD-IC-IV57
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  2 years

Secondary Outcomes (3)

• 1-year Survival Rates

  1 year

• 3-year Survival Rates

  3 years

• Number of patients suffered adverse events

  42 months

Other Outcomes (1)

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

  2 years

Study Arms (1)

Icotinib

EXPERIMENTAL

Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.

Drug: Icotinib

Interventions

Icotinib DRUG

Icotinib is administered 125 mg three times per day.

Also known as: Commana, BPI-2009

Icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhang Yi, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: October 1, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Locations

CN (1)