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NCT Number: NCT02486354

Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

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.

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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 3

Primary location

307 Hospital of PLA, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Icotinib

Drug

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

Other names: Conmana

Primary outcomes

  1. progression-free survival

    Time frame: 6 months

Secondary outcomes

  1. overall survival

    Time frame: 12 months

  2. objective response rate

    Time frame: 2 months

  3. number of patients suffered adverse events

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 1, 2015
Registry last updated
Jul 1, 2015

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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