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
Sponsored by
About this trial
This is an interventional treatment trial for EGFR Gene Mutation
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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.
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
No
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
Email
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
Email
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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