Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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icotinib

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

Group Type EXPERIMENTAL

icotinib

Intervention Type 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.

Interventions

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icotinib

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

Intervention Type DRUG

Other Intervention Names

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Conmana

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Sun, MD

Role: STUDY_CHAIR

Cancer Hospital Chinese Academy of Medical Science

Locations

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