Icotinib as an Adjuvant Therapy for Patients With Stage I... | NCT02044328

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

NCT02044328

Sponsor

Betta Pharmaceuticals Co., Ltd.

Status

Completed

Last Update Posted

Feb 8, 2022Actual

Enrollment

79Actual

Phase

Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

Icotinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Oct 2021Actual

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2022

Last Update Posted Date

Feb 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Icotinib	Experimental	Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.	Drug: Icotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Icotinib	Drug	Icotinib is administered 125 mg three times per day.	Icotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free survival		2 years

Secondary Outcomes

Measure	Description	Time Frame
1-year Survival Rates		1 year
3-year Survival Rates		3 years
Number of patients suffered adverse events

Other Outcomes

Measure	Description	Time Frame
Difference of disease-free survival by status of Bcl-2 interacting mediator of cell death	Compare the disease-free survival between patients with positive Bcl-2 interacting mediator of cell death mutation and patients without this mutation.	2 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhang Yi, MD	Xuanwu Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital, Capital Medical University		Beijing	Beijing Municipality	100053	China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531470	icotinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided