Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (ICOGEN)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Zhejiang Beta Pharma Inc.

ClinicalTrials.gov Identifier:

NCT01040780

First received: December 27, 2009

Last updated: August 27, 2012

Last verified: August 2012

History of Changes

Results First Received: February 21, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Non-small Cell Lung Cancer
Interventions:	Drug: Icotinib Drug: Gefitinib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled between 26 Febrary 2009 and 13 November 2010 across 27 study sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Icotinib	Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib	Gefitinib 250 mg every 24 hours by mouth

Participant Flow: Overall Study

	Icotinib	Gefitinib
STARTED	200	199
COMPLETED	199	196
NOT COMPLETED	1	3
Protocol Violation	1	3

Baseline Characteristics

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Reporting Groups

	Description
Icotinib	Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib	Gefitinib 250 mg every 24 hours by mouth
Total	Total of all reporting groups

Baseline Measures

	Icotinib	Gefitinib	Total
Number of Participants [units: participants]	200	199	399
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	164	159	323
>=65 years	36	40	76
Age [units: years] Mean ± Standard Deviation	55.52 ± 10.14	56.43 ± 9.43	55.98 ± 9.79
Gender [units: participants]
Female	82	85	167
Male	118	114	232
Region of Enrollment [units: participants]
China	200	199	399

Outcome Measures

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1. Primary:

Progression Free Survival [ Time Frame: 2-7 months ]

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2. Secondary:

Overall Survival [ Time Frame: From first study treatment until time of death ]

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3. Secondary:

Best Tumor Response [ Time Frame: While receiving study treatment; assessed every 21 days until progression ]

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4. Secondary:

Time To Progression [ Time Frame: 2-7 months ]

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5. Secondary:

Safety and Tolerability [ Time Frame: Assessed over two years ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	Events were collected by systematic assessment

Reporting Groups

	Description
Icotinib	Icotinib 125 mg three times daily (375 mg per day) by mouth
Gefitinib	Gefitinib 250 mg every 24 hours by mouth

Serious Adverse Events

	Icotinib	Gefitinib
Total, serious adverse events
# participants affected / at risk	13/200 (6.50%)	15/199 (7.54%)
Cardiac disorders
Cardiac failure ^{† 1}
# participants affected / at risk	2/200 (1.00%)	0/199 (0.00%)
# events	2	0
Cardio-respiratory failure ^{† 1}
# participants affected / at risk	1/200 (0.50%)	0/199 (0.00%)
# events	1	0
Gastrointestinal disorders
Vomiting ^{† 1}
# participants affected / at risk	0/200 (0.00%)	1/199 (0.50%)
# events	0	1
Intestinal obstruction ^{† 1}
# participants affected / at risk	1/200 (0.50%)	0/199 (0.00%)
# events	1	0
Anorexia ^{† 1}
# participants affected / at risk	0/200 (0.00%)	1/199 (0.50%)
# events	0	1
General disorders
Haemorrhage ^{† 1}
# participants affected / at risk	1/200 (0.50%)	0/199 (0.00%)
# events	1	0
Multi-organ failure ^{† 1}
# participants affected / at risk	1/200 (0.50%)	2/199 (1.01%)
# events	1	2
Hospitalization due to progression ^{† 1}
# participants affected / at risk	1/200 (0.50%)	0/199 (0.00%)
# events	1	0
Infections and infestations
Pneumonia ^{† 1}
# participants affected / at risk	0/200 (0.00%)	2/199 (1.01%)
# events	0	2
Injury, poisoning and procedural complications
Injury ^{* 1}
# participants affected / at risk	0/200 (0.00%)	1/199 (0.50%)
# events	0	1
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	1/200 (0.50%)	0/199 (0.00%)
# events	1	0
Respiratory, thoracic and mediastinal disorders
Respiratory failure ^{† 1}
# participants affected / at risk	4/200 (2.00%)	5/199 (2.51%)
# events	4	5
Haemoptysis ^{† 1}
# participants affected / at risk	1/200 (0.50%)	2/199 (1.01%)
# events	1	2
Pleural effusion ^{† 1}
# participants affected / at risk	1/200 (0.50%)	1/199 (0.50%)
# events	1	1

†	Events were collected by systematic assessment
*	Events were collected by non-systematic assessment
1	Term from vocabulary, CTCAE (3.0)

Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Yan Sun, M.D.
Organization: Cancer Hospital, Chinese Academy of Medical Sciences
phone: 0086-010-87788519
e-mail: zhangheping@csco.org.cn

No publications provided by Zhejiang Beta Pharma Inc.

Publications automatically indexed to this study:

Tan F, Shen X, Wang D, Xie G, Zhang X, Ding L, Hu Y, He W, Wang Y, Wang Y. Icotinib (BPI-2009H), a novel EGFR tyrosine kinase inhibitor, displays potent efficacy in preclinical studies. Lung Cancer. 2012 May;76(2):177-82. Epub 2011 Nov 22.

Responsible Party:	Zhejiang Beta Pharma Inc.
ClinicalTrials.gov Identifier:	NCT01040780 History of Changes
Other Study ID Numbers:	BPI-2009
Study First Received:	December 27, 2009
Results First Received:	February 21, 2012
Last Updated:	August 27, 2012
Health Authority:	China: Food and Drug Administration

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