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Icotinib as Consolidation Therapy After Chemoradiotherapy in EGFR-Mutant Stage IIIA-IIIB Non-small Cell Lung Cancer

Primary Purpose

EGFR Gene Mutation, Non Small Cell Lung Cancer Stage IIIA, Non Small Cell Lung Cancer Stage IIIB

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Icotinib

About this trial

This is an interventional treatment trial for EGFR Gene Mutation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method
Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan
Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease )
Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin)
3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times
ECOG score 0-1
Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy
Expected survival more than 12 weeks

Exclusion Criteria:

Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma
In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy
Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease
Upper vena cava syndrome at baseline
Idiopathic pulmonary fibrosis detected by CT at baseline
Definite neurological or psychiatric disorders, including epilepsy or dementia
Pregnant or lactating women

Sites / Locations

Cancer Hospital, Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib

Arm Description

Patients with EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib with a dose of 125 mg three times per day orally till progressive disease or unaccepted toxicity as consolidation therapy after synchronous or sequential chemoradiotherapy.

Outcomes

Primary Outcome Measures

Relapse Free Survival of participants

Relapse Free Survival was defined as the time from randomization to relapse of disease or death from any cause.

Secondary Outcome Measures

Overall survival of participants

Overall survival was defined as the time from participants' randomization to their death due to any cause.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug.

Full Information

NCT ID

NCT03396185

First Posted

December 28, 2017

Last Updated

July 17, 2018

Sponsor

Betta Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03396185

Brief Title

Icotinib as Consolidation Therapy After Chemoradiotherapy in EGFR-Mutant Stage IIIA-IIIB Non-small Cell Lung Cancer

Official Title

Icotinib as Consolidation Therapy After Synchronous or Sequential Chemoradiotherapy in Stage IIIA-IIIB Non-small Cell Lung Cancer With EGFR Sensitive Mutation: A Single Center, Single Arm, Open Label and Prospective Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 9, 2018 (Actual)

Primary Completion Date

February 1, 2022 (Anticipated)

Study Completion Date

February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the relapse free survival of patients who have EGFR-mutant stage IIIA-IIIB Non-small Cell Lung Cancer and receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy.

Detailed Description

This is a single center, single arm, open label and prospective clinical study. Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy. The primary objective of this study is relapse free survival. The secondary objectives are overall survival, the frequency of adverse events and patients' quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

EGFR Gene Mutation, Non Small Cell Lung Cancer Stage IIIA, Non Small Cell Lung Cancer Stage IIIB

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Icotinib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Icotinib

Other Intervention Name(s)

Conmana

Intervention Description

Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib with a dose of 125 mg three times per day orally till progressive disease or unaccepted toxicity as consolidation therapy after synchronous or sequential chemoradiotherapy.

Primary Outcome Measure Information:

Title

Relapse Free Survival of participants

Description

Relapse Free Survival was defined as the time from randomization to relapse of disease or death from any cause.

Time Frame

three years

Secondary Outcome Measure Information:

Title

Overall survival of participants

Description

Overall survival was defined as the time from participants' randomization to their death due to any cause.

Time Frame

three years

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug.

Time Frame

three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease ) Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin) 3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times ECOG score 0-1 Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy Expected survival more than 12 weeks Exclusion Criteria: Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease Upper vena cava syndrome at baseline Idiopathic pulmonary fibrosis detected by CT at baseline Definite neurological or psychiatric disorders, including epilepsy or dementia Pregnant or lactating women

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junling Li, MD

Phone

13801178891

drlijunling@vip.163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Puyuan Xing, MD

Facility Information:

Facility Name

Cancer Hospital, Chinese Academy of Medical Science

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junling Li, MD

Phone

13801178891

drlijunling@vip.163.com

First Name & Middle Initial & Last Name & Degree

Puyuan Xing, MD

Phone

18611417207

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Icotinib as Consolidation Therapy After Chemoradiotherapy in EGFR-Mutant Stage IIIA-IIIB Non-small Cell Lung Cancer

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